A Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis (GMG). Anitocabtagene autoleucel (anito-cel) is a BCMA-directed CAR-T cell therapy.

Start Date01 Jan 2025

Sponsor / Collaborator

Arcellx, Inc.

NCT06413498 / RecruitingPhase 3

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug.
The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM as measured by progression-free survival (PFS) per blinded independent review committee (IRC).

Start Date23 Aug 2024

Sponsor / Collaborator

Kite Pharma, Inc.

[+1]

NCT05396885 / RecruitingPhase 2

A Phase II Study of CART-ddBCMA for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy.

Start Date09 Aug 2022

Sponsor / Collaborator

Kite Pharma, Inc.

[+1]

100 Clinical Results associated with Anitocabtagene autoleucel

100 Translational Medicine associated with Anitocabtagene autoleucel

100 Patents (Medical) associated with Anitocabtagene autoleucel

Literatures (Medical) associated with Anitocabtagene autoleucel

01 Nov 2023·Blood Cancer Discovery

IVIg Use Associated with Ten-Fold Reduction of Serious Infections in Multiple Myeloma Patients Treated with Anti-BCMA Bispecific Antibodies

Article

Author: Thibaud, Santiago ; Lurie, Alaina ; Avery, Lisa ; Cho, Hearn Jay ; Parekh, Samir S ; Sanchez, Larysa J ; Lancman, Guido ; Kotlarz, Krzysztof ; Jagannath, Sundar ; Parsa, Kian ; Chari, Ajai ; Lieberman-Cribbin, Alex ; Rossi, Adriana ; Richard, Shambavi ; Richter, Joshua ; Rodriguez, Cesar

AbstractBCMA-targeted bispecific antibodies (BiAb) are efficacious in relapsed/refractory multiple myeloma; however, serious infections have emerged as important toxicities. In this retrospective study, we characterized all infections and their risk factors, and evaluated the impact of infection prophylaxis in patients treated with BCMA-targeted BiAbs. Among 37 patients, 15 (41%) experienced a grade 3–5 infection, with two infection-related deaths during deep remissions. Most (84%) infections occurred during disease remissions. The cumulative probability of grade 3–5 infection increased over time with no plateau. Among responders (n = 26), profound hypogammaglobulinemia occurred in 100% and continued throughout the entire duration of treatment. During periods when patients were receiving intravenous immunoglobulin (IVIg), the rate of grade 3–5 infections was 90% lower than during observation (incidence rate ratio, 0.10; 95% confidence interval, 0.01–0.80; P = 0.0307). No other risk factors for infection were identified. This study demonstrates that profound hypogammaglobulinemia is universal with BCMA-targeted BiAbs, with intravenous immunoglobulin potentially abrogating most of the infection risk.Significance:To the best of our knowledge, this is the first study to comprehensively analyze risk factors and mitigation strategies to prevent infections in myeloma patients receiving anti-BCMA bispecific antibodies. Profound and prolonged hypogammaglobulinemia was universal among responders, while immunoglobulin replacement was associated with 90% lower rates of grade 3–5 infections.See related commentary by Garfall and Stadtmauer, p. 427 .This article is featured in Selected Articles from This Issue, p. 419

14 Mar 2023·Blood AdvancesQ2 · MEDICINE

Phase 1 study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma

Q2 · MEDICINE

Article

Author: Cook, Daniella ; Rosenblatt, Jacalyn ; Jakubowiak, Andrzej ; Bishop, Michael R ; Logan, Emma ; Shen, Angela ; Yee, Andrew J ; Griffin, Faith ; Frigault, Matthew J ; Daley, Heather ; Shaw, Kit ; Avigan, David E ; Raje, Noopur ; Maus, Marcela V ; Cornwell, Christine ; Heery, Christopher ; O'Donnell, Elizabeth K ; Nikiforow, Sarah

AbstractRelapsed and refractory multiple myeloma (RRMM) is a plasma cell neoplasm defined by progressively refractory disease necessitating chronic and increasingly intensive therapy. Despite recent advances, limited treatment options exist for RRMM. This single-arm, open label phase 1 study aimed to evaluate the safety of novel B-cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T construct that leverages a completely synthetic antigen-binding domain (CART-ddBCMA), which was specifically engineered to reduce immunogenicity and improve CAR cell surface stability. Thirteen patients ≥18 years with RRMM who received at least 3 prior regimens of systemic therapy were enrolled in the study. Patients received a single dose of 100 × 106 CART-ddBCMA (DL1) or 300 × 106 CART-ddBCMA (DL2) following standard lymphodepleting chemotherapy. The primary endpoints of the study were to evaluate the incidence of treatment emergent adverse events, including dose-limiting toxicities, and establish a recommended phase 2 dose. Results showed that CART-ddBCMA was well tolerated and demonstrated a favorable toxicity profile. Only 1 case of grade ≥3 cytokine release syndrome and 1 case of immune effector cell–associated neurotoxicity were reported; both were at DL2 and were manageable with standard treatment. No atypical neurological toxicities and Parkinson disease-like movement disorders were observed. The maximum tolerated dose was not reached. All infused patients responded to CART-ddBCMA, and 9/12 (75%) patients achieved complete response/stringent complete response. Responses deepened over time, and at the time of last data-cut (median follow-up 56 weeks), 8/9 (89%) evaluable patients achieved minimal residual disease negativity. In conclusion, the findings demonstrate the safety of CART-ddBCMA cells and document durable responses to CART-ddBCMA in patients with RRMM. This trial was registered at www.clinicaltrials.gov as #NCT04155749.

05 Jul 2022·Molecular Cancer Therapeutics

Preclinical Efficacy of BCMA-Directed CAR T Cells Incorporating a Novel D Domain Antigen Recognition Domain

Article

Author: Richman, Laura K. ; Zaritskaya, Liubov ; Edwards, Justin P. ; Witter, Alexandra R. ; Gupta, Ankit ; Tice, David A. ; Hilbert, David M. ; LaFleur, David W. ; Buonato, Janine M.

AbstractChimeric antigen receptor (CAR) T-cell therapies directed against B-cell maturation antigen (BCMA) have shown compelling clinical activity and manageable safety in subjects with relapsed and refractory multiple myeloma (RRMM). Prior reported CAR T cells have mostly used antibody fragments such as humanized or murine single-chain variable fragments or camelid heavy-chain antibody fragments as the antigen recognition motif. Herein, we describe the generation and preclinical evaluation of ddBCMA CAR, which uses a novel BCMA binding domain discovered from our D domain phage display libraries and incorporates a 4-1BB costimulatory motif and CD3-zeta T-cell activation domain. Preclinical in vitro studies of ddBCMA CAR T cells cocultured with BCMA-positive cell lines showed highly potent, dose-dependent measures of cytotoxicity, cytokine production, T-cell degranulation, and T-cell proliferation. In each assay, ddBCMA CAR performed as well as the BCMA-directed scFv-based C11D5.3 CAR. Furthermore, ddBCMA CAR T cells demonstrated in vivo tumor suppression in three disseminated BCMA-expressing tumor models in NSG-immunocompromised mice. On the basis of these promising preclinical data, CART-ddBCMA is being studied in a first-in-human phase I clinical study to assess the safety, pharmacokinetics, immunogenicity, efficacy, and duration of effect for patients with RRMM (NCT04155749).

News (Medical) associated with Anitocabtagene autoleucel

06 Nov 2024

·www.businesswire.com

Gilead Sciences Announces Third Quarter 2024 Financial Results

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) announced today its third quarter 2024 results of operations. “Gilead’s third quarter results are the strongest of the year to date, with 7% year-over-year revenue growth, including 13% year-over-year growth for Biktarvy. Based on this very strong topline growth and disciplined operating expense management, we are increasing our full year revenue, operating income, and earnings per share guidance,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “We are excited to further increase our impact for patients and communities in the months ahead. This includes building on the momentum from the U.S. launch of Livdelzi for primary biliary cholangitis and preparing for the potential launch of the first twice-yearly option for HIV prevention option, lenacapavir.” Third Quarter 2024 Financial Results Total third quarter 2024 revenue increased 7% to $7.5 billion compared to the same period in 2023, primarily due to higher sales in HIV as well as in Veklury ® (remdesivir), Oncology and Liver Disease. Diluted earnings per share (“EPS”) was $1.00 in the third quarter 2024 compared to $1.73 in the same period in 2023. The decrease was primarily driven by a pre-tax in-process research and development (“IPR&D”) impairment of $1.75 billion, or $1.04 per share net of tax impact, related to assets acquired by Gilead from Immunomedics, Inc. (“Immunomedics”) in 2020, as well as higher acquired IPR&D expense. This was partially offset by higher product sales and higher net unrealized gains on equity securities. Non-GAAP diluted EPS was $2.02 in the third quarter 2024 compared to $2.29 in the same period in 2023. The decrease was primarily driven by higher acquired IPR&D and tax expense, partially offset by higher product sales. As of September 30, 2024, Gilead had $5.0 billion of cash, cash equivalents and marketable debt securities compared to $8.4 billion as of December 31, 2023. The decrease primarily reflects the $3.9 billion acquisition of CymaBay Therapeutics, Inc. During the third quarter 2024 Gilead generated $4.3 billion in operating cash flow. During the third quarter 2024 Gilead paid dividends of $983 million and repurchased $300 million of common stock. Third Quarter 2024 Product Sales Total third quarter 2024 product sales increased 7% to $7.5 billion compared to the same period in 2023. Total third quarter 2024 product sales, excluding Veklury, increased 7% to $6.8 billion compared to the same period in 2023, primarily due to higher sales in HIV as well as in Oncology and Liver Disease. HIV product sales increased 9% to $5.1 billion in the third quarter 2024 compared to the same period in 2023, driven by higher average realized price, primarily due to shifts in channel mix, and higher demand, partially offset by inventory dynamics. Biktarvy ® (bictegravir 50mg/emtricitabine 200mg (“FTC”)/tenofovir alafenamide 25mg (“TAF”)) sales increased 13% to $3.5 billion in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand and average realized price, partially offset by inventory dynamics. Descovy ® (FTC 200mg/TAF 25mg) sales increased 15% to $586 million in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand and average realized price, partially offset by inventory dynamics. The Liver Disease portfolio sales increased 4% to $733 million in the third quarter 2024 compared to the same period in 2023. This was primarily driven by higher demand in viral hepatitis medicines, partially offset by unfavorable pricing dynamics. Veklury sales increased 9% to $692 million in the third quarter 2024 compared to the same period in 2023, primarily driven by increased rates of COVID-19 related hospitalizations, particularly in the United States. Cell Therapy product sales of $485 million in the third quarter 2024 were relatively flat compared to the same period in 2023. Yescarta ® (axicabtagene ciloleucel) sales decreased 1% to $387 million in the third quarter 2024 compared to the same period in 2023, reflecting increased in- and out-of-class competition in the United States, partially offset by increased demand in relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) in other regions. Tecartus ® (brexucabtagene autoleucel) sales increased 2% to $98 million in the third quarter 2024 compared to the same period in 2023, driven by increased demand in adult acute lymphoblastic leukemia (“ALL”). Trodelvy ® (sacituzumab govitecan-hziy) sales increased 17% to $332 million in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand across all regions. Third Quarter 2024 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin was 79.1% in the third quarter 2024 compared to 77.6% in the same period in 2023. Non-GAAP product gross margin was 86.8% in the third quarter 2024 compared to 85.9% in the same period in 2023. The increases in GAAP and non-GAAP were primarily driven by product mix. Research & development (“R&D”) expenses and non-GAAP R&D expenses were $1.4 billion in the third quarter 2024 compared to $1.5 billion in the same period in 2023. The decreases were primarily driven by the timing of clinical activities, including the wind-down of the magrolimab and obeldesivir COVID programs. Acquired IPR&D expenses were $505 million in the third quarter 2024, primarily driven by a $320 million charge related to the buy-out of global Livdelzi ® (seladelpar) royalties from Janssen Pharmaceutica NV, as well as payments related to ongoing collaborations. IPR&D impairment was $1.75 billion related to the assets acquired from Immunomedics in 2020 with no similar charges in 2023. Selling, general and administrative (“SG&A”) expenses and non-GAAP SG&A expenses were $1.4 billion in the third quarter 2024 compared to $1.3 billion in the same period in 2023. The increases reflect the timing of commercial activities, including the launch of Livdelzi in the United States, and other corporate activities. The effective tax rate (“ETR”) was (31.1)% in the third quarter 2024 compared to 6.3% in the same period in 2023. The decrease in ETR primarily reflects the impact of a legal entity restructuring and the aforementioned Immunomedics IPR&D impairment expense, partially offset by a prior year decrease in tax reserves that did not repeat. Non-GAAP ETR was 17.5% in the third quarter 2024 compared to 7.0% in the same period in 2023, primarily reflecting the impact of the prior year decrease in tax reserves. Guidance and Outlook For the full-year 2024, Gilead expects: (in millions, except per share amounts) November 6, 2024 Guidance Low End High End Comparison to August 8, 2024 Guidance Product sales $ 27,800 $ 28,100 Previously $27,100 to $27,500 Product sales, excluding Veklury $ 26,000 $ 26,300 Previously $25,800 to $26,200 Veklury $ 1,800 $ 1,800 Previously $1,300 Diluted EPS $ 0.05 $ 0.25 Previously $0.00 to $0.30 Non-GAAP diluted EPS $ 4.25 $ 4.45 Previously $3.60 to $3.90 Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2024 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below. Key Updates Since Our Last Quarterly Release Virology Announced results of PURPOSE 2, the second Phase 3 study of twice-yearly lenacapavir for HIV prevention, with data presented at the HIV Research for Prevention Conference. In the lenacapavir group, 99.9% of participants did not acquire HIV infection, with 2 incident cases among 2,179 participants. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence in cisgender men and gender-diverse people, and additionally demonstrated superiority to daily Truvada ® (FTC 200mg and tenofovir disoproxil fumarate 300mg; 89% relative risk reduction). Lenacapavir was generally well-tolerated and no significant or new safety concerns were identified. Gilead expects to file for U.S. Food and Drug Administration (“FDA”) approval before the end of the year, with global filings to follow. The use of lenacapavir for the prevention of HIV is investigational. Presented HIV treatment data at the Infection Disease Week (“IDWeek”) meeting, including Week 48 data from the Phase 2 study evaluating the investigational oral once-weekly combination regimen of lenacapavir with Merck’s, known as MSD outside of the United States and Canada (“Merck”), islatravir. In addition, Phase 1a data of the investigational once-weekly GS-1720 and 3-year follow up from the Phase 2/3 CAPELLA trial of twice-yearly lenacapavir in people with multi-drug resistant HIV were also highlighted. Signed royalty-free voluntary licensing agreements with six manufacturers to make and sell generic lenacapavir for HIV prevention and for HIV treatment in heavily treatment-experienced adults with multi-drug resistant HIV in 120 high-incidence, resource-limited countries, subject to regulatory approval of lenacapavir in those markets. Presented data at IDWeek from the Phase 3 BIRCH and OAKTREE trials of investigational obeldesivir in non-hospitalized participants at high-risk or standard-risk for severe COVID-19, respectively. Previously, Gilead announced the early termination of the BIRCH trial and top-line results from the OAKTREE trial which found that while the study did not meet its primary endpoint, obeldesivir was found to have a generally well tolerated safety profile. The detailed data presented add to the breadth of safety data on obeldesivir. Donated approximately 5,000 vials of remdesivir to the Rwanda Medical Supply in response to the Marburg Virus Disease (“MVD”) outbreak for emergency use. Remdesivir is not approved for the treatment of MVD anywhere globally, and the safety and efficacy of this use is not known. Oncology Announced abstracts for the American Society of Hematology 2024 Annual Meeting (“ASH”), including preliminary data from the registrational Phase 2 iMMagine-1 trial evaluating the Arcellx, Inc. (“Arcellx”) partnered investigational CAR T anito-cel (anitocabtagene autoleucel) in R/R multiple myeloma, as well as updated results from the Phase 1 trial. Additionally, the first patient has been dosed in the Phase 3 iMMagine-3 trial in 2L+ R/R multiple myeloma. Announced ASH abstracts for long-term follow-up of Yescarta in R/R indolent non-Hodgkin’s lymphoma and Tecartus in R/R mantle cell lymphoma, as well as real world data for Tecartus in B-cell precursor ALL. Presented Trodelvy data at the International Association for the Study of Lung Cancer World Conference on Lung Cancer across first- and second-line advanced or metastatic non-small cell lung cancer, as well as in extensive-stage small cell lung cancer. The use of Trodelvy for lung cancer is investigational. Announced plans to voluntarily withdraw the U.S. accelerated approval of Trodelvy for use in pre-treated adult patients with locally advanced or metastatic urothelial cancer, following the results of the Phase 3 TROPiCS-04 trial announced in May 2024. Received FDA Regenerative Medicine Advanced Therapy Designation for the evaluation of Yescarta as first-line treatment for adult patients with newly diagnosed, high-risk LBCL, an investigational use. Inflammation Received FDA accelerated approval for Livdelzi for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (“UDCA”) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis. Corporate Announced a strategic collaboration with Genesis Therapeutics, Inc. (“Genesis”) to discover and develop novel small molecule therapies across multiple targets using Genesis’ GEMS AI platform. The Board declared a quarterly dividend of $0.77 per share of common stock for the fourth quarter of 2024. The dividend is payable on December 30, 2024, to stockholders of record at the close of business on December 13, 2024. Future dividends will be subject to Board approval. Certain amounts and percentages in this press release may not sum or recalculate due to rounding. Conference Call At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on http://investors.gilead.com and will be archived on www.gilead.com for one year. Non-GAAP Financial Information The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with such exclusions as well as changes in tax-related laws and guidelines, transfers of intangible assets between certain legal entities, and legal entity restructurings. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilead’s ability to achieve its anticipated full year 2024 financial results, including as a result of the uncertainty of the amount and timing of Veklury revenues; Gilead’s ability to make progress on any of its long-term ambitions or priorities laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its virology, oncology and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including the arrangements with Arcellx, Genesis and Merck; patent protection and estimated loss of exclusivity for our products and product candidates; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timeframes or at all, the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Trodelvy, anito-cel, GS-1720, lenacapavir, and obeldesivir (such as the BIRCH, CAPELLA, iMMagine-1, iMMagine-3, OAKTREE, and PURPOSE-2 studies), and the risk that safety and efficacy data from clinical trials may not warrant further development of Gilead’s product candidates or the product candidates of Gilead’s strategic partners; Gilead’s ability to submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines, including for lenacapavir for HIV PrEP; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, and the risk that any such approvals, if granted, may be subject to significant limitations on use and may be subject to withdrawal or other adverse actions by the applicable regulatory authority; Gilead’s ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead’s products; pricing and reimbursement pressures from government agencies and other third parties, including required rebates and other discounts; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of Gilead’s products over other therapies and may therefore be reluctant to prescribe the products, including Livdelzi; and other risks identified from time to time in Gilead’s reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter ended September 30, 2024 are not necessarily indicative of operating results for any future periods. Gilead directs readers to its press releases, annual reports on Form 10-K, quarterly reports on Form 10-Q and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The reader is cautioned that forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD ® , GILEAD SCIENCES ® , KITE TM , AMBISOME ® , ATRIPLA ® , BIKTARVY ® , CAYSTON ® , COMPLERA ® , DESCOVY ® , DESCOVY FOR PREP ® , EMTRIVA ® , EPCLUSA ® , EVIPLERA ® , GENVOYA ® , HARVONI ® , HEPCLUDEX ® , HEPSERA ® , JYSELECA ® , LIVDELZI ® , LETAIRIS ® , ODEFSEY ® , SOVALDI ® , STRIBILD ® , SUNLENCA ® , TECARTUS ® , TRODELVY ® , TRUVADA ® , TRUVADA FOR PREP ® , TYBOST ® , VEKLURY ® , VEMLIDY ® , VIREAD ® , VOSEVI ® , YESCARTA ® and ZYDELIG ® . For more information on Gilead Sciences, Inc., please visit www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235). GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except per share amounts) 2024 2023 2024 2023 Revenues: Product sales $ 7,515 $ 6,994 $ 21,074 $ 19,864 Royalty, contract and other revenues 30 56 111 138 Total revenues 7,545 7,051 21,185 20,002 Costs and expenses: Cost of goods sold 1,574 1,565 4,670 4,408 Research and development expenses 1,395 1,457 4,266 4,310 Acquired in-process research and development expenses 505 91 4,674 808 In-process research and development impairment 1,750 — 4,180 — Selling, general and administrative expenses 1,433 1,315 4,184 4,482 Total costs and expenses 6,657 4,428 21,975 14,009 Operating income (loss) 888 2,623 (790 ) 5,993 Interest expense 238 232 728 692 Other (income) expense, net (306 ) 72 (41 ) 95 Income (loss) before income taxes 956 2,318 (1,477 ) 5,206 Income tax (benefit) expense (297 ) 146 (174 ) 1,010 Net income (loss) 1,253 2,172 (1,303 ) 4,196 Net loss attributable to noncontrolling interest — (8 ) — (40 ) Net income (loss) attributable to Gilead $ 1,253 $ 2,180 $ (1,303 ) $ 4,236 Basic earnings (loss) per share attributable to Gilead $ 1.00 $ 1.75 $ (1.04 ) $ 3.39 Shares used in basic earnings (loss) per share attributable to Gilead calculation 1,247 1,248 1,247 1,249 Diluted earnings (loss) per share attributable to Gilead $ 1.00 $ 1.73 $ (1.04 ) $ 3.37 Shares used in diluted earnings (loss) per share attributable to Gilead calculation 1,254 1,257 1,247 1,259 Supplemental Information: Cash dividends declared per share $ 0.77 $ 0.75 $ 2.31 $ 2.25 Product gross margin 79.1 % 77.6 % 77.8 % 77.8 % Research and development expenses as a % of revenues 18.5 % 20.7 % 20.1 % 21.5 % Selling, general and administrative expenses as a % of revenues 19.0 % 18.6 % 19.8 % 22.4 % Operating margin 11.8 % 37.2 % (3.7 )% 30.0 % Effective tax rate (31.1 )% 6.3 % 11.8 % 19.4 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Product sales: HIV $ 5,073 $ 4,667 9% $ 14,160 $ 13,482 5% Liver Disease 733 706 4% 2,302 2,093 10% Oncology 816 769 6% 2,446 2,167 13% Other 201 216 (7)% 705 658 7% Total product sales excluding Veklury 6,823 6,358 7% 19,613 18,400 7% Veklury 692 636 9% 1,461 1,465 —% Total product sales 7,515 6,994 7% 21,074 19,864 6% Royalty, contract and other revenues 30 56 (46)% 111 138 (19)% Total revenues $ 7,545 $ 7,051 7% $ 21,185 $ 20,002 6% GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION (1) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Non-GAAP: Cost of goods sold $ 995 $ 985 1% $ 2,933 $ 2,717 8% Research and development expenses $ 1,382 $ 1,453 (5)% $ 4,120 $ 4,268 (3)% Acquired IPR&D expenses (2) $ 505 $ 91 NM $ 4,674 $ 808 NM Selling, general and administrative expenses $ 1,405 $ 1,298 8% $ 4,051 $ 4,464 (9)% Other (income) expense, net $ (48 ) $ (96 ) (50)% $ (189 ) $ (261 ) (28)% Diluted earnings per share attributable to Gilead $ 2.02 $ 2.29 (12)% $ 2.72 $ 5.00 (46)% Shares used in non-GAAP diluted earnings per share attributable to Gilead calculation 1,254 1,257 —% 1,254 1,259 —% Product gross margin 86.8 % 85.9 % 84 bps 86.1 % 86.3 % -24 bps Research and development expenses as a % of revenues 18.3 % 20.6 % -229 bps 19.4 % 21.3 % -189 bps Selling, general and administrative expenses as a % of revenues 18.6 % 18.4 % 21 bps 19.1 % 22.3 % -320 bps Operating margin 43.2 % 45.7 % -255 bps 25.5 % 38.7 % -1320 bps Effective tax rate 17.5 % 7.0 % 1052 bps 30.0 % 14.5 % 1552 bps ________________________________ NM - Not Meaningful (1) Refer to Non-GAAP Financial Information section above for further disclosures on non-GAAP financial measures. A reconciliation between GAAP and non-GAAP financial information is provided in the tables below. (2) Equal to GAAP financial information. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,574 $ 1,565 $ 4,670 $ 4,408 Acquisition-related – amortization (1) (579 ) (581 ) (1,737 ) (1,691 ) Restructuring — — 1 — Non-GAAP cost of goods sold $ 995 $ 985 $ 2,933 $ 2,717 Product gross margin reconciliation: GAAP product gross margin 79.1 % 77.6 % 77.8 % 77.8 % Acquisition-related – amortization (1) 7.7 % 8.3 % 8.2 % 8.5 % Restructuring — % — % (— )% — % Non-GAAP product gross margin 86.8 % 85.9 % 86.1 % 86.3 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,395 $ 1,457 $ 4,266 $ 4,310 Acquisition-related – other costs (2) (9 ) 1 (78 ) (37 ) Restructuring (5 ) (5 ) (68 ) (5 ) Non-GAAP research and development expenses $ 1,382 $ 1,453 $ 4,120 $ 4,268 IPR&D impairment reconciliation: GAAP IPR&D impairment $ 1,750 $ — $ 4,180 $ — IPR&D impairment (1,750 ) — (4,180 ) — Non-GAAP IPR&D impairment $ — $ — $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,433 $ 1,315 $ 4,184 $ 4,482 Acquisition-related – other costs (2) (5 ) — (88 ) (2 ) Restructuring (23 ) (17 ) (45 ) (17 ) Non-GAAP selling, general and administrative expenses $ 1,405 $ 1,298 $ 4,051 $ 4,464 Operating income (loss) reconciliation: GAAP operating income (loss) $ 888 $ 2,623 $ (790 ) $ 5,993 Acquisition-related – amortization (1) 579 581 1,737 1,691 Acquisition-related – other costs (2) 13 (1 ) 167 39 Restructuring 28 22 112 22 IPR&D impairment 1,750 — 4,180 — Non-GAAP operating income $ 3,258 $ 3,224 $ 5,406 $ 7,745 Operating margin reconciliation: GAAP operating margin 11.8 % 37.2 % (3.7 )% 30.0 % Acquisition-related – amortization (1) 7.7 % 8.2 % 8.2 % 8.5 % Acquisition-related – other costs (2) 0.2 % — % 0.8 % 0.2 % Restructuring 0.4 % 0.3 % 0.5 % 0.1 % IPR&D impairment 23.2 % — % 19.7 % — % Non-GAAP operating margin 43.2 % 45.7 % 25.5 % 38.7 % Other (income) expense, net reconciliation: GAAP other (income) expense, net $ (306 ) $ 72 $ (41 ) $ 95 Gain (loss) from equity securities, net 258 (168 ) (148 ) (356 ) Non-GAAP other (income) expense, net $ (48 ) $ (96 ) $ (189 ) $ (261 ) Income (loss) before income taxes reconciliation: GAAP income (loss) before income taxes $ 956 $ 2,318 $ (1,477 ) $ 5,206 Acquisition-related – amortization (1) 579 581 1,737 1,691 Acquisition-related – other costs (2) 13 (1 ) 167 39 Restructuring 28 22 112 22 IPR&D impairment 1,750 — 4,180 — (Gain) loss from equity securities, net (258 ) 168 148 356 Non-GAAP income before income taxes $ 3,068 $ 3,088 $ 4,866 $ 7,314 GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Income tax (benefit) expense reconciliation: GAAP income tax (benefit) expense $ (297 ) $ 146 $ (174 ) $ 1,010 Income tax effect of non-GAAP adjustments: Acquisition-related – amortization (1) 121 120 363 347 Acquisition-related – other costs (2) 2 — 39 8 Restructuring 4 5 21 5 IPR&D impairment 440 — 1,051 — (Gain) loss from equity securities, net (46 ) 4 (52 ) 5 Discrete and related tax charges (3) 314 (58 ) 214 (314 ) Non-GAAP income tax expense $ 538 $ 216 $ 1,461 $ 1,061 Effective tax rate reconciliation: GAAP effective tax rate (31.1 )% 6.3 % 11.8 % 19.4 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments (3) 48.6 % 0.7 % 18.2 % (4.9 )% Non-GAAP effective tax rate 17.5 % 7.0 % 30.0 % 14.5 % Net income (loss) attributable to Gilead reconciliation: GAAP net income (loss) attributable to Gilead $ 1,253 $ 2,180 $ (1,303 ) $ 4,236 Acquisition-related – amortization (1) 458 461 1,374 1,345 Acquisition-related – other costs (2) 11 (1 ) 128 31 Restructuring 24 17 92 17 IPR&D impairment 1,310 — 3,129 — (Gain) loss from equity securities, net (212 ) 164 200 351 Discrete and related tax charges (3) (314 ) 58 (214 ) 314 Non-GAAP net income attributable to Gilead $ 2,531 $ 2,879 $ 3,405 $ 6,293 Diluted earnings (loss) per share reconciliation: GAAP diluted earnings (loss) per share $ 1.00 $ 1.73 $ (1.04 ) $ 3.37 Acquisition-related – amortization (1) 0.37 0.37 1.10 1.07 Acquisition-related – other costs (2) 0.01 — 0.10 0.02 Restructuring 0.02 0.01 0.07 0.01 IPR&D impairment 1.04 — 2.51 — (Gain) loss from equity securities, net (0.17 ) 0.13 0.16 0.28 Discrete and related tax charges (3) (0.25 ) 0.05 (0.17 ) 0.25 Difference in shares used for GAAP vs. Non-GAAP — — (0.01 ) — Non-GAAP diluted earnings per share $ 2.02 $ 2.29 $ 2.72 $ 5.00 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 581 $ 1,736 $ 1,691 Research and development expenses adjustments 13 4 146 42 IPR&D impairment adjustments 1,750 — 4,180 — Selling, general and administrative expenses adjustments 28 17 133 19 Total non-GAAP adjustments to costs and expenses 2,370 602 6,196 1,752 Other (income) expense, net adjustments (258 ) 168 148 356 Total non-GAAP adjustments before income taxes 2,113 770 6,343 2,108 Income tax effect of non-GAAP adjustments above (521 ) (129 ) (1,421 ) (364 ) Discrete and related tax charges (3) (314 ) 58 (214 ) 314 Total non-GAAP adjustments to net income attributable to Gilead $ 1,278 $ 699 $ 4,708 $ 2,057 ________________________________ (1) Relates to amortization of acquired intangibles. (2) Adjustments include integration expenses, contingent consideration fair value adjustments and other expenses associated with Gilead’s acquisitions of MYR GmbH, MiroBio, Ltd., Tmunity Therapeutics, Inc., XinThera, Inc. and CymaBay Therapeutics, Inc. (3) Represents discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and in-process research and development, transfers of intangible assets from a foreign subsidiary to Ireland and the United States, and legal entity restructurings. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP 2024 FULL-YEAR GUIDANCE (1) (unaudited) (in millions, except percentages and per share amounts) Provided February 6, 2024 Updated April 25, 2024 Updated August 8, 2024 Updated November 6, 2024 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 76.0% - 77.0% 76.0% - 77.0% 76.0% - 77.0% 78.0% Acquisition-related expenses and restructuring expenses ~ 9.0% ~ 9.0% ~ 9.0% ~ 8.0% Non-GAAP projected product gross margin 85.0% - 86.0% 85.0% - 86.0% 85.0% - 86.0% 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $8,700 - $9,200 $1,900 - $2,400 $2,100 - $2,500 $1,100 - $1,400 IPR&D impairment, acquisition-related and restructuring expenses ~ 2,500 ~ 5,100 ~ 5,100 ~ 6,900 Non-GAAP projected operating income $11,200 - $11,700 $7,000 - $7,500 $7,200 - $7,600 $8,000 - $8,300 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 21% ~ 65% ~ 87% ~ 56% Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments (~ 2%) (~ 35%) (~ 57%) (~ 29%) Non-GAAP projected effective tax rate ~ 19% ~ 30% ~ 30% ~ 27% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.15 - $5.55 $0.10 - $0.50 $0.00 - $0.30 $0.05 - $0.25 IPR&D impairment, acquisition-related and restructuring expenses, fair value adjustments of equity securities and discrete and related tax adjustments ~ 1.70 ~ 3.35 ~ 3.60 ~ 4.20 Non-GAAP projected diluted EPS $6.85 - $7.25 $3.45 - $3.85 $3.60 - $3.90 $4.25 - $4.45 ________________________________ (1) Our full-year guidance excludes the potential impact of any (i) acquisitions or business development transactions that have not been executed, (ii) future fair value adjustments of equity securities and (iii) discrete tax charges or benefits associated with changes in tax related laws and guidelines that have not been enacted, as Gilead is unable to project such amounts. The non-GAAP full-year guidance includes non-GAAP adjustments to actual current period results as well as adjustments for the known future impact associated with events that have already occurred, such as future amortization of our intangible assets and the future impact of discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and in-process research and development, transfers of intangible assets from a foreign subsidiary to Ireland and the United States, and legal entity restructurings. GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) September 30, December 31, (in millions) 2024 2023 Assets Cash, cash equivalents and marketable debt securities $ 5,037 $ 8,428 Accounts receivable, net 4,587 4,660 Inventories 3,435 3,366 Property, plant and equipment, net 5,391 5,317 Intangible assets, net 20,546 26,454 Goodwill 8,314 8,314 Other assets 7,215 5,586 Total assets $ 54,525 $ 62,125 Liabilities and Stockholders’ Equity Current liabilities $ 11,725 $ 11,280 Long-term liabilities 24,409 28,096 Stockholders’ equity (1) 18,390 22,749 Total liabilities and stockholders’ equity $ 54,525 $ 62,125 ________________________________ (1) As of September 30, 2024 and December 31, 2023, there were 1,246 shares of common stock issued and outstanding. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 4,309 $ 1,756 $ 7,853 $ 5,837 Net cash used in investing activities (710 ) (229 ) (3,224 ) (1,538 ) Net cash used in financing activities (1,379 ) (1,518 ) (5,693 ) (4,026 ) Effect of exchange rate changes on cash and cash equivalents 44 (7 ) 15 20 Net change in cash and cash equivalents 2,265 1 (1,049 ) 293 Cash and cash equivalents at beginning of period 2,772 5,704 6,085 5,412 Cash and cash equivalents at end of period $ 5,037 $ 5,705 $ 5,037 $ 5,705 Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 4,309 $ 1,756 $ 7,853 $ 5,837 Capital expenditures (140 ) (122 ) (376 ) (370 ) Free cash flow (1) $ 4,169 $ 1,633 $ 7,478 $ 5,467 ________________________________ (1) Free cash flow is a non-GAAP liquidity measure. Please refer to our disclosures in the Non-GAAP Financial Information section above. GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2024 2023 2024 2023 HIV Biktarvy – U.S. $ 2,826 $ 2,504 $ 7,726 $ 7,104 Biktarvy – Europe 375 313 1,110 920 Biktarvy – Rest of World 272 268 814 717 3,472 3,085 9,649 8,741 Descovy – U.S. 534 460 1,339 1,314 Descovy – Europe 24 25 75 75 Descovy – Rest of World 28 26 82 86 586 511 1,496 1,475 Genvoya – U.S. 384 433 1,088 1,305 Genvoya – Europe 44 47 138 157 Genvoya – Rest of World 21 23 66 81 449 503 1,292 1,544 Odefsey – U.S. 248 257 705 754 Odefsey – Europe 69 74 217 223 Odefsey – Rest of World 9 11 30 33 326 343 952 1,011 Symtuza - Revenue share (1) – U.S. 103 96 338 278 Symtuza - Revenue share (1) – Europe 33 32 101 101 Symtuza - Revenue share (1) – Rest of World 3 3 9 10 139 131 448 390 Other HIV (2) – U.S. 65 56 190 192 Other HIV (2) – Europe 26 28 96 91 Other HIV (2) – Rest of World 9 9 36 38 100 94 322 321 Total HIV – U.S. 4,161 3,807 11,386 10,949 Total HIV – Europe 570 519 1,737 1,568 Total HIV – Rest of World 342 341 1,038 965 5,073 4,667 14,160 13,482 Liver Disease Sofosbuvir / Velpatasvir (3) – U.S. 222 215 737 643 Sofosbuvir / Velpatasvir (3) – Europe 67 76 230 250 Sofosbuvir / Velpatasvir (3) – Rest of World 96 85 299 266 385 377 1,266 1,159 Vemlidy – U.S. 126 112 338 295 Vemlidy – Europe 11 9 33 28 Vemlidy – Rest of World 95 106 328 322 232 228 699 645 Other Liver Disease (4) – U.S. 45 49 134 113 Other Liver Disease (4) – Europe 54 33 148 112 Other Liver Disease (4) – Rest of World 17 20 55 64 116 102 337 289 Total Liver Disease – U.S. 393 376 1,210 1,051 Total Liver Disease – Europe 132 119 411 390 Total Liver Disease – Rest of World 207 211 682 652 733 706 2,302 2,093 Veklury Veklury – U.S. 393 258 784 607 Veklury – Europe 81 65 204 227 Veklury – Rest of World 219 313 473 630 692 636 1,461 1,465 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2024 2023 2024 2023 Oncology Cell Therapy Tecartus – U.S. 63 64 181 179 Tecartus – Europe 29 27 102 83 Tecartus – Rest of World 6 4 22 11 98 96 305 272 Yescarta – U.S. 145 197 502 624 Yescarta – Europe 182 154 509 408 Yescarta – Rest of World 60 40 170 99 387 391 1,181 1,130 Total Cell Therapy – U.S. 208 261 683 802 Total Cell Therapy – Europe 211 181 611 491 Total Cell Therapy – Rest of World 66 45 192 109 485 486 1,485 1,402 Trodelvy Trodelvy – U.S. 226 201 655 551 Trodelvy – Europe 80 62 217 169 Trodelvy – Rest of World 26 21 88 44 332 283 960 764 Total Oncology – U.S. 433 462 1,338 1,354 Total Oncology – Europe 291 243 828 660 Total Oncology – Rest of World 92 65 280 153 816 769 2,446 2,167 Other AmBisome – U.S. 6 12 37 39 AmBisome – Europe 71 63 210 192 AmBisome – Rest of World 52 39 176 150 130 115 424 381 Other (5) – U.S. 47 69 203 197 Other (5) – Europe 8 9 26 31 Other (5) – Rest of World 16 23 52 49 71 101 281 277 Total Other – U.S. 53 82 241 236 Total Other – Europe 80 72 236 224 Total Other – Rest of World 68 62 228 199 201 216 705 658 Total product sales – U.S. 5,433 4,985 14,958 14,196 Total product sales – Europe 1,154 1,017 3,416 3,069 Total product sales – Rest of World 928 992 2,700 2,599 $ 7,515 $ 6,994 $ 21,074 $ 19,864 ________________________________ (1) Represents Gilead’s revenue from cobicistat (“C”), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company. (2) Includes Atripla, Complera/Eviplera, Emtriva, Sunlenca, Stribild, Truvada and Tybost. (3) Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”). (4) Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Livdelzi, Sovaldi, Viread and Vosevi. (5) Includes Cayston, Jyseleca, Letairis, Ranexa and Zydelig.

Clinical ResultPhase 2Phase 3Breakthrough TherapyDrug Approval

05 Nov 2024

·www.businesswire.com

Kite to Highlight Industry-Leading CAR T-Cell Therapy Portfolio at ASH 2024, Including Positive Survival Outcomes in Both Clinical Trials and the Real-World

SANTA MONICA, Calif.--( BUSINESS WIRE )--Kite, a Gilead Company (Nasdaq: GILD), will share 18 presentations, including six oral presentations, demonstrating the strength of its CAR T-cell therapy portfolio across a spectrum of blood cancers during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition (December 7-10). “ Our data underscore our commitment to helping people with blood cancers live longer and demonstrate the benefit of CAR T-cell therapy as a mainstay of blood cancer treatment,” said Dominique Tonelli, M.D., VP, Global Head of Medical Affairs, Kite. “ Notably for this year, along with our partner Arcellx, we are excited to share clinically meaningful data from the Phase 1 study and the iMMagine-1 Phase 2 registrational study of anito-cel for the treatment of relapsed/refractory multiple myeloma.” Anito-cel Data from Partner, Arcellx Key presentations for anitocabtagene autoleucel (anito-cel) include data from the Phase 1 study that demonstrate a 30.2-month median progression-free survival (PFS) with a median follow-up of 38.1 months and the median overall survival not yet reached; and preliminary results from 58 patients in the Phase 2 iMMagine-1 study that demonstrate a 95% objective response rate (ORR) and a 62% complete response / stringent complete response (CR/sCR) at a median follow-up of 10.3 months. Additional patients with a more recent data cut for the Phase 2 iMMagine-1 study will be presented in an oral presentation. Both the Phase 1 and Phase 2 iMMagine-1 studies highlight durable responses in patients with relapsed or refractory (R/R) multiple myeloma (MM) and show no delayed neurotoxicities have been observed to date, including no parkinsonism, no cranial nerve palsies, and no Guillain Barre syndrome. Positive Survival Outcomes with Yescarta ® and Tecartus ® Key presentations for Yescarta ® (axicabtagene ciloleucel) include a five-year follow-up analysis from ZUMA-5 evaluating response rate and long-term survival in patients with R/R indolent non-Hodgkin lymphoma (iNHL), including follicular lymphoma and marginal zone lymphoma. Additionally, Yescarta is the only treatment to have demonstrated superior overall survival versus standard therapy for patients with early R/R large B-cell lymphoma (LBCL), and this continues to be seen in the largest real-world analysis of patients with R/R LBCL who received second-line Yescarta. Additional research will focus on improvements in Yescarta manufacturing for patients with R/R LBCL. Key presentations for Tecartus ® (brexucabtagene autoleucel) include five-year outcomes from ZUMA-2 cohorts 1 and 2 and a primary analysis of ZUMA-2 cohort 3, both highlighting durable responses in adult patients with R/R mantle cell lymphoma (MCL) and showing that Tecartus continues to deliver unprecedented efficacy in R/R MCL three years after its approval. Also to be presented are real-world outcomes in adults with R/R B-cell precursor acute lymphoblastic leukemia (B-ALL) treated with Tecartus, highlighting the CAR T-cell therapy’s high effectiveness in a broader R/R B-ALL patient population. Advancements in Kite’s pipeline will also be highlighted, including data presented on Kite’s next generation CAR T-cell therapy KITE-753, an autologous anti-CD19/CD20 CAR T-cell therapy for the treatment of B-cell malignancies. Kite is also collaborating with independent investigators and respected institutions including The Lymphoma Study Association, Sarah Cannon Transplant and Cellular Therapy Network, and Dana-Farber Cancer Institute to share additional insights on Kite’s CAR T-cell therapies. Dates and times* for accepted abstracts and presentations of note are as follows: *Times listed are in PT Oral Presentations Abstract Details Titles Axicabtagene ciloleucel Abstract #526 Sunday, December 8, 2024 10:15 AM Marriott Marquis San Diego Marina, Pacific Ballroom Salons 24-26 Real-World Early Outcomes of Second-Line Axicabtagene Ciloleucel (Axi-Cel) Therapy in Patients (Pts) With Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) Abstract #527 Sunday, December 8, 2024 10:30 AM Marriott Marquis San Diego Marina, Pacific Ballroom Salons 24-26 Real-world Trends of Cytokine Release Syndrome and Neurologic Events, and Pattern of Their Management among Patients Receiving Axicabtagene Ciloleucel for Relapsed or Refractory (r/r) Large B-cell Lymphoma (LBCL) in the US: a CIBMTR Report Abstract #609 Sunday, December 8, 2024 12:30 PM Marriott Marquis San Diego Marina, Marriott Grand Ballroom 2-4 Predictors of Early Safety Outcomes with Axicabtagene Ciloleucel (axi-cel) in Patients with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) Abstract #864 Monday, December 9, 2024 4:00 PM Marriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13 5-Year Follow-Up Analysis From ZUMA-5: a Phase 2 Trial of Axicabtagene Ciloleucel (Axi-Cel) in Patients With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma Brexucabtagene autoleucel Abstract #748 Monday, December 9, 2024 11:15 AM Marriott Marquis San Diego Marina, Marriott Grand Ballroom 8-9 Primary Analysis of ZUMA-2 Cohort 3: Brexucabtagene Autoleucel (Brexu-Cel) in Patients (Pts) With Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Who Were Naive to Bruton Tyrosine Kinase Inhibitors (BTKi) Anitocabtagene autoleucel Abstract #1031 Monday, December 9, 2024 5:30 PM Marriott Marquis San Diego Marina, Pacific Ballroom 24-26 Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma: Preliminary Results From the iMMagine-1 Trial *Led by Arcellx Poster Presentations Axicabtagene ciloleucel Abstract #2367 Saturday, December 7, 2024 5:30 PM - 7:30 PM San Diego Convention Center, Halls G-H Treatment Patterns and Predictors of Survival after First Line Therapy in Large B-Cell Lymphoma in a Real-World US Cohort Abstract #3347 Sunday, December 8, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Improvements in Axicabtagene Ciloleucel Manufacturing Result in High Delivery Success and More Predictable Turnaround Time for Patients With Relapsed/Refractory Large B-Cell Lymphoma Abstract #4368 Monday, December 9, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Impact of Inflammation, Tumor and Product Attributes on Clinical Outcomes in Patients with Relapsed/Refractory Follicular Lymphoma Treated with Axicabtagene Ciloleucel Abstract #5037 Monday, December 9, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Estimating the Impact on Survival of Not Receiving CAR T Therapy Despite Being Eligible in Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Patients in Germany Brexucabtagene autoleucel Abstract #4388 Monday, December 9, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Five-Year Outcomes of Patients (Pts) With Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Treated With Brexucabtagene Autoleucel (Brexu-cel) in ZUMA-2 Cohorts 1 and 2 Abstract #5092 Monday, December 9, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Real-World (RW) Outcomes for Brexucabtagene Autoleucel (Brexu-Cel) Treatment in Patients (Pts) With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) by High-Risk Features and Prior Treatments: Updated Evidence From the CIBMTR® Registry Abstract #4193 Monday, December 9, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Impact of disease burden, CAR-T expansion, and mononuclear cell recovery on overall response and duration of response in ZUMA-3 pivotal study Anitocabtagene autoleucel Abstract #4825 Monday, December 9, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM): Efficacy and Safety With 34-Month Median Follow-up *Led by Arcellx Kite next generation CAR T-cell therapies Abstract #3481 Sunday, December 8, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H KITE-753: An Autologous Rapid Manufactured Anti-CD19/CD20 CAR-T Product for the Treatment of B-cell Malignancies Investigator-Sponsored / Collaboration** Abstract #4505 Sunday, December 8, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Health-related quality of life after Axi-cel as a second-line therapy in patients with high-risk relapsed/refractory large B-cell lymphoma who are ineligible for autologous stem cell transplantation: results of the ALYCANTE phase II trial *Led by The Lymphoma Study Association Abstract #4721 Monday, December 9, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Health Related Quality of Life (HRQoL) in Relapsed/Refractory Multiple Myeloma (RRMM): A Systematic Literature Review (SLR) and Meta-Analysis *Investigator led Abstract #3734 Sunday, December 8, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H The Patient Journey and Treatment Outcomes Comparing Inpatient Versus Outpatient Axicabtagene Ciloleucel in Non-Hodgkin’s Lymphoma (NHL) - a Large, Multicenter Study *In collaboration with Sarah Cannon Transplant and Cellular Therapy Network Abstract #3124 Sunday, December 8, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H CAR T-cells for relapsed/refractory B-cell lymphoma in people living with HIV (PLWH): a LYSA study from the DESCAR-T registry *Led by The Lymphoma Study Association Abstract #2031 Saturday, December 7, 2024 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Early MRD detection after CAR-T Associated with Poor Outcome in LBCL *In collaboration with Dana-Farber Cancer Institute Abstract #239 Saturday, December 7, 2024 3:00 PM Session: 623 (2:00 - 3:30 PM) Marriot Grand Ballroom 11-13 Outcome of patients with Mantle cell lymphoma after failure of anti-CD19 CAR T-cell therapy: a DESCAR-T Study By Lysa Group *Led by The Lymphoma Study Association Abstract # Date TBD Time TBD Room TBD A Real-World Weighted Comparison of Tisagenlecleucel and Axicabtagene Ciloleucel CAR T Cells in Relapsed or Refractory Diffuse Large B Cell Lymphoma Aged 75 Years and Older: A Lysa Study from the Descar-T Registry *Led by The Lymphoma Study Association Publication Only Abstract #7775 Real-World Interim PET/CT Scan Use During Frontline (1L) Therapy and Subsequent Treatment Characteristics in Patients with Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Abstract #7607 Short-term Costs Associated With Outpatient Use of Axicabtagene Ciloleucel in Second-line Relapsed/Refractory Large B-cell Lymphoma Based on ZUMA-24 Clinical Trial Abstract #7592 A United States (US) Cost-Effectiveness Analysis of Axicabtagene Ciloleucel Compared to Odronextamab in Third Line or Later (3L+) Diffuse Large B-Cell Lymphoma Abstract #6962 Treatment Patterns and Outcomes in Triple-Class Exposed Patients with Relapsed and Refractory Multiple Myeloma: Findings from the Flatiron Database Abstract #7159 In Vitro and In Vivo Characterization of Axicabtagene Ciloleucel Identifies Features Associated with Treatment Resistance in Patients, Including a Dysfunctional CD8+ T Cell State Characterized by Overexpression of GATA3 Transcript For more information, including a complete list of abstract titles at the meeting, please visit: https://ash.confex.com/ash/2024/webprogram/start.html **Presentations independently led and sponsored feature Kite CAR T-cell therapies but are not included in total number of Kite accepted abstracts. About Yescarta Please see full Prescribing Information , including BOXED WARNING and Medication Guide. YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma. Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). U.S. IMPORTANT SAFETY INFORMATION BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids, as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program. CYTOKINE RELEASE SYNDROME (CRS) CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL) receiving YESCARTA, including ≥ Grade 3 (Lee grading system1) CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 CRS in 9%. Among patients with LBCL who died after receiving YESCARTA, four had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1 to 12 days) and the median duration of CRS was 7 days (range: 2 to 58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1 to 10 days) and the median duration was 7 days (range: 2 to 43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, one patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1 to 20 days) and the median duration was 6 days (range: 1 to 27 days) for patients with iNHL. Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) . The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in two subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events. CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1 to 8 days) and the median duration of CRS was 7 days (range: 2 to 16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS at which point the patients were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 or higher CRS. The median time to onset of CRS was 5 days (range: 1 to 15 days) and the median duration of CRS was 4 days (range: 1 to 10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities. Ensure that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. NEUROLOGIC TOXICITIES Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life- threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1- 133 days) and median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL. The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred. The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset and decrease the duration of CRS. Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly. REMS Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483). HYPERSENSITIVITY REACTIONS Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA. SERIOUS INFECTIONS Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including ≥ Grade 3 or higher infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. PROLONGED CYTOPENIAS Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion. HYPOGAMMAGLOBULINEMIA B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment. SECONDARY MALIGNANCIES Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period. ADVERSE REACTIONS The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting. The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias. The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness. About Tecartus Please see full FDA Prescribing Information , including BOXED WARNING and Medication Guide. Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). U.S. IMPORTANT SAFETY INFORMATION BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving Tecartus. Do not administer Tecartus to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurologic toxicities, including life-threatening reactions, occurred in patients receiving Tecartus, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Tecartus. Provide supportive care and/or corticosteroids as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program. Cytokine Release Syndrome (CRS) , including life-threatening reactions, occurred following treatment with Tecartus. CRS occurred in 92% (72/78) of patients with ALL, including ≥ Grade 3 (Lee grading system) CRS in 26% of patients. Three patients with ALL had ongoing CRS events at the time of death. The median time to onset of CRS was five days (range: 1 to 12 days) and the median duration of CRS was eight days (range: 2 to 63 days) for patients with ALL. Ensure that a minimum of two doses of tocilizumab are available for each patient prior to infusion of Tecartus. Following infusion, monitor patients for signs and symptoms of CRS daily for at least seven days at the certified healthcare facility, and for four weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Neurologic Events , including those that were fatal or life-threatening, occurred following treatment with Tecartus. Neurologic events occurred in 87% (68/78) of patients with ALL, including ≥ Grade 3 in 35% of patients. The median time to onset for neurologic events was seven days (range: 1 to 51 days) with a median duration of 15 days (range: 1 to 397 days) in patients with ALL. For patients with MCL, 54 (66%) patients experienced CRS before the onset of neurological events. Five (6%) patients did not experience CRS with neurologic events and eight patients (10%) developed neurological events after the resolution of CRS. Neurologic events resolved for 119 out of 134 (89%) patients treated with Tecartus. Nine patients (three patients with MCL and six patients with ALL) had ongoing neurologic events at the time of death. For patients with ALL, neurologic events occurred before, during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of patients; respectively. Three patients (4%) had neurologic events without CRS. The onset of neurologic events can be concurrent with CRS, following resolution of CRS or in the absence of CRS. The most common neurologic events (>10%) were similar in MCL and ALL and included encephalopathy (57%), headache (37%), tremor (34%), confusional state (26%), aphasia (23%), delirium (17%), dizziness (15%), anxiety (14%), and agitation (12%). Serious events including encephalopathy, aphasia, confusional state, and seizures occurred after treatment with Tecartus. Monitor patients daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility and for four weeks following infusion for signs and symptoms of neurologic toxicities and treat promptly. REMS Program: Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program which requires that: Healthcare facilities that dispense and administer Tecartus must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of two doses of tocilizumab are available for each patient for infusion within two hours after Tecartus infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer Tecartus are trained in the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483). Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus. Severe Infections: Severe or life-threatening infections occurred in patients after Tecartus infusion. Infections (all grades) occurred in 56% (46/82) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 30% of patients with ALL and MCL. Tecartus should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Tecartus infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 6% of patients with MCL and 35% of patients with ALL after Tecartus infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) of patients with ALL includes events of “febrile neutropenia” (11 (14%)) plus the concurrent events of “fever” and “neutropenia” (16 (21%)). In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies (e.g., fungal and viral infections such as HHV-6 and progressive multifocal leukoencephalopathy) should be considered in patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Tecartus infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 55% (45/82) of patients and included thrombocytopenia (38%), neutropenia (37%), and anemia (17%). In patients with ALL who were responders to Tecartus treatment, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following Tecartus infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%). Monitor blood counts after Tecartus infusion. Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Tecartus. Hypogammaglobulinemia was reported in 16% (13/82) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with Tecartus and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following Tecartus treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least six weeks prior to the start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery following treatment with Tecartus. Secondary Malignancies may develop. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing. Effects on Ability to Drive and Use Machines: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Tecartus infusion. Advise patients to refrain from driving and engaging in hazardous activities, such as operating heavy or potentially dangerous machinery, during this period. Adverse Reactions: The most common non-laboratory adverse reactions (≥ 20%) were fever, cytokine release syndrome, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. The most common serious adverse reactions (≥ 2%) were cytokine release syndrome, febrile neutropenia, hypotension, encephalopathy, fever, infection with pathogen unspecified, hypoxia, tachycardia, bacterial infections, respiratory failure, seizure, diarrhea, dyspnea, fungal infections, viral infections, coagulopathy, delirium, fatigue, hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema, and paraparesis. Please see full Prescribing Information , including BOXED WARNING and Medication Guide. About Kite Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial supply and commercial product manufacturing. For more information on Kite, please visit www.kitepharma.com . About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Gilead acquired Kite in 2017. About Arcellx and Kite Collaboration Arcellx and Kite, a Gilead Company, formed a global strategic collaboration and license agreement to co-develop and co-commercialize anito-cel for patients with relapsed or refractory multiple myeloma, RRMM. Anito-cel is currently being developed in a Phase 2 registrational pivotal study and a Phase 3 randomized controlled study for RRMM. Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States. About Anitocabtagene autoleucel (anito-cel) Anitocabtagene autoleucel (anito-cel, previously CART-ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration. About iMMagine-3 Global Phase 3 Randomized Controlled Clinical Study iMMagine-3 is a global Phase 3, randomized controlled study designed to compare the efficacy and safety of anitocabtagene autoleucel (anito-cel) with standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody. iMMagine-3 will enroll approximately 450 adult patients. Prior to randomization, investigator’s choice of SOC regimens include: pomalidomide, bortezomib, and dexamethasone (PVd); daratumumab, pomalidomide, and dexamethasone (DPd); carfilzomib, daratumumab and dexamethasone (KDd); or carfilzomib and dexamethasone (Kd). Patients in the anito-cel arm will undergo leukapheresis and optional bridging therapy (with the SOC regimen selected by the investigator prior to randomization) followed by lymphodepleting chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300 mg/m2/d for 3 days) and one infusion of anito-cel (115×106 CAR+ T cells) on Day 1. The primary endpoint is progression free survival (PFS) per blinded independent review according to the 2016 IMWG uniform response criteria for MM with the hypothesis that anito-cel will prolong PFS compared to SOC. Key secondary endpoints include complete response rate (CR/sCR), minimal residual disease negativity, overall survival, and safety. The iMMagine-3 study initiated in the second half of 2024 at approximately 130 study sites across North America, Europe, and rest of world. Forward-Looking Statements This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Tecartus, Yescarta anito-cel and KITE-753 (such as iMMagine-1, ZUMA-2, ZUMA-3 and ZUMA-5); uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation; the possibility that Gilead and Kite may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements. Tecartus, Yescarta, Gilead, the Gilead logo, Kite, the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information on Kite, please visit the company’s website at www.kitepharma.com . Follow Kite on social media on X (@KitePharma) and LinkedIn .

Phase 2Clinical ResultCell TherapyImmunotherapyASH

05 Nov 2024

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Arcellx to Present Clinical Data for Its Phase 1 and iMMagine-1 Studies in Patients with Relapsed or Refractory Multiple Myeloma at the 66th ASH Annual Meeting and Exposition and Announces Progress in iMMagine-3 Study

REDWOOD CITY, Calif.--( BUSINESS WIRE )--Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced that it will present clinical data in a poster presentation from its Phase 1 study (abstract #4825) of anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma (RRMM); preliminary clinical data in an oral presentation from its iMMagine-1 study (abstract #1031) in patients with RRMM; and a health-related quality of life systematic literature review and meta-analysis (abstract #4721) in patients with RRMM in a poster presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 7-10, 2024, in San Diego, California. Additionally, an abstract (#6962) describing the treatment patterns and outcomes in triple-class exposed patients with RRMM will be published in a supplemental issue of Blood in November 2024. The company will also have a medical affairs booth (#1615) in Hall E of the San Diego Convention Center. Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma: Preliminary Results From the iMMagine-1 Trial (abstract #1031) As detailed in the abstract (#1031) as of June 1, 2024, 58 patients had received anito-cel infusion with ≥2 months of follow-up after infusion, with a median follow-up of 10.3 months (range, 2.0-17.8). The median age was 66 years (range, 38-77). Patients had received a median of four prior lines of treatment (range, 3-8) with 26 patients (45%) having received only three prior lines of treatment. Forty patients (69%) were triple-class refractory and 20 (34%) were penta-class refractory. Investigator-assessed overall response rate (ORR) per International Myeloma Working Group (IMWG) criteria was 95% (55/58) with a complete response/stringent complete response (CR/sCR) rate of 62% (36/58). Of those evaluable for minimal residual disease (MRD) testing (n=39), 36 (92%) achieved MRD negativity at least to the level of 10 -5 . The Kaplan–Meier-estimated 6-month progression-free survival (PFS) and overall survival (OS) rates (95% CI) were 90% (77-96) and 95% (85-98), respectively. Median (mPFS) and median OS have not yet been reached. No delayed neurotoxicities, including no parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome have been observed to date. Forty-six patients (79%) had either no cytokine release syndrome (CRS) (n=9, 16%) or Grade (Gr) 1 CRS (n=37, 64%). Thirty-one patients (53%) had no fever or CRS in the first four days of anito-cel. Any Grade CRS was observed in 49 patients (84%; Gr3/4 0%). Any Grade ICANS was observed in 5 patients (9%; Gr3 2%), with all cases resolved without sequelae. Three deaths occurred due to adverse events (AEs) (both related and unrelated; retroperitoneal hemorrhage, CRS, and fungal infection). No additional treatment or therapy-related deaths or Grade ≥3 CRS or ICANs events have occurred to date. Cytopenias were the most common Grade ≥3 treatment-emergent AEs; 36 patients (62%) had Grade ≥3 neutropenia, 15 (26%) had Grade ≥3 thrombocytopenia, and 15 (26%) had Grade ≥3 anemia. Conclusions Preliminary results from the first 58 patients in the Phase 2 iMMagine-1 study demonstrate deep and durable responses and manageable safety in a high-risk fourth line or higher (4L+) RRMM population including triple- and penta-class refractory disease. Notably, no delayed neurotoxicities, including no cranial nerve palsies, Guillain-Barré syndrome, or Parkinsonian-like symptoms have been observed with anito-cel to date. Updated Phase 2 data with a more recent data cut will be presented at the oral presentation during ASH. Presentation details: Speaker : Ciara Freeman, M.D., Ph.D., H. Lee Moffitt Cancer Center Session Name : 655. Multiple Myeloma: Cellular Therapies: Unleashing Cell Therapies Against Myeloma Session Date : Monday, December 9, 2024 Session Time : 4:30 p.m. - 6:00 p.m. Presentation Time : 5:30 p.m. Location : Marriott Marquis San Diego Marina, Pacific Ballroom Salons 24-26 Publication Number : 1031 Submission ID : 198499 Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) (abstract #4825) In the Phase 1 study, 40 patients were enrolled and 38 patients received anito-cel. All 38 patients demonstrated investigator-assessed clinical response per 2016 IMWG criteria, (ORR, 100%) with 30 CR/sCR (≥CR rate, 79%), 5 very good partial response (≥VGPR rate, 92%), and 3 partial response (PR). Of those evaluable for MRD testing (n=28), 25 (89%) achieved MRD negativity at 10 -5 . With a median follow-up of 38.1 months, median OS was not reached and median PFS was 30.2 months. The safety profile was manageable with no delayed neurotoxicities observed to date, including no parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome. Further investigations of anito-cel are ongoing in 4L+ RRMM (iMMagine-1, NCT05396885) and in earlier lines (iMMagine-3, NCT06413498). Presentation details: Speaker : Michael R. Bishop, M.D., The University of Chicago Session Name : 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities Session Date : Monday, December 9, 2024 Presentation Time : 6:00 p.m. - 8:00 p.m. Location : San Diego Convention Center, Halls G-H Publication Number : 4825 Submission ID : 201080 Health Related Quality of Life (HRQoL) in Relapsed/Refractory Multiple Myeloma (RRMM): A Systematic Literature Review (SLR) and Meta-Analysis (abstract #4721) Quantifying pre-treatment HRQoL burden is important as a reference for contextualizing baseline patient burden as emerging therapies for RRMM continue to evolve. This SLR synthesized studies that reported data for key multiple myeloma HRQoL instruments. It found that patients with RRMM had clinically meaningful impairments from population norms in important domains, such as Global Health Status and cognitive, physical, and emotional functioning. The SLR also found that pre-treatment HRQoL worsened with increasing lines of therapy. Presentation details: Speaker : Rahul Banerjee, M.D., Fred Hutchinson Cancer Center Session Name : 653. Multiple Myeloma: Clinical and Epidemiological: Poster III Session Date : Monday, December 9, 2024 Presentation Time : 6:00 p.m. - 8:00 p.m. Location : San Diego Convention Center, Halls G-H Treatment Patterns and Outcomes in Triple-Class Exposed Patients with Relapsed and Refractory Multiple Myeloma: Findings from the Flatiron Database (abstract #6962) In order to understand the contemporary unmet need in the rapidly evolving treatment landscape for patients with triple-class exposed RRMM - those exposed to immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies - in the 4L+ setting, a retrospective cohort study using the Flatiron Health electronic health record (HER) was conducted (sample size=594). This study found no clear standard of care in the 4L+ setting, and suboptimal health outcomes under the current treatment landscape (ORR=34%, PFS=4.1 months, and OS=15.4 months), emphasizing an urgent need for more effective and durable therapies for patients in this setting. This abstract will be published in a supplemental issue of Blood in November 2024. Webcast Event: Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Monday, December 9, 2024 at 8:30 p.m. PT. The event will be accessible from Arcellx's website at www.arcellx.com in the Investors section. A webcast replay will be archived and available for 30 days following the event. About Multiple Myeloma Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient's immune function. Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering. About Anitocabtagene Autoleucel (anito-cel) Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration. About iMMagine-3, A Global Phase 3 Randomized Controlled Clinical Study iMMagine-3 is a global Phase 3, randomized controlled study designed to compare the efficacy and safety of anitocabtagene autoleucel (anito-cel) with standard of care in patients with relapsed and/or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody. iMMagine-3 will enroll approximately 450 adult patients. Prior to randomization, investigator’s choice of SOC regimens include: pomalidomide, bortezomib, and dexamethasone (PVd); daratumumab, pomalidomide, and dexamethasone (DPd); carfilzomib, daratumumab, and dexamethasone (KDd); or carfilzomib and dexamethasone (Kd). Patients in the anito-cel arm will undergo leukapheresis and optional bridging therapy (with the SOC regimen selected by the investigator prior to randomization) followed by lymphodepleting chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300 mg/m2/d for 3 days) and one infusion of anito-cel (115×106 CAR+ T cells) on Day 1. The primary endpoint is progression-free survival (PFS) per blinded independent review according to the 2016 IMWG uniform response criteria for MM with the hypothesis that anito-cel will prolong PFS compared to SOC. Key secondary endpoints include complete response rate (CR/sCR), minimal residual disease negativity, overall survival, and safety. The iMMagine-3 study initiated in the second half of 2024 at approximately 130 study sites across North America, Europe, and the rest of the world. About Arcellx and Kite Collaboration Arcellx and Kite, a Gilead Company, formed a global strategic collaboration and license agreement to co-develop and co-commercialize anito-cel for patients with relapsed or refractory multiple myeloma, RRMM. Anito-cel is currently being developed in a Phase 2 registrational pivotal study and a global Phase 3 randomized controlled study for RRMM. Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States. About Arcellx, Inc. Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx's mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. For more information on Arcellx, please visit www.arcellx.com . Follow Arcellx on X @arcellx and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including Arcellx’s plans for the clinical development of its product candidates; anticipated announcements of additional data; anito-cel tolerability and toxicity trends; Arcellx’s competitive positioning; expectations regarding manufacturing time; the potential commrical launch of anito-cel, subject to FDA approval; and the potential impact of Arcellx’s product candidates and platforms on patients and cell therapy. The forward-looking statements contained herein are based upon Arcellx’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in Part II, Item 1A (Risk Factors) in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission (SEC) on August 8, 2024, and the other documents that Arcellx may file from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Myeloma	Phase 3	US	Kite Pharma, Inc.	23 Aug 2024
Multiple Myeloma	Phase 3	US	Arcellx, Inc.	23 Aug 2024
Plasma cell myeloma refractory	Phase 2	US	Arcellx, Inc.	09 Aug 2022
Plasma cell myeloma refractory	Phase 2	US	Kite Pharma, Inc.	09 Aug 2022
Relapse multiple myeloma	Phase 2	US	Arcellx, Inc.	09 Aug 2022
Relapse multiple myeloma	Phase 2	US	Kite Pharma, Inc.	09 Aug 2022
Muscle Weakness	Phase 1	-	Arcellx, Inc.	01 Jan 2025
Myasthenia Gravis	Phase 1	-	Arcellx, Inc.	01 Jan 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05396885 (iMMagine-1, ASH2024) Manual	Phase 2	Multiple Myeloma Last line	58	Anitocabtagene autoleucel	(okorpvsika) = gzwtdxjlad tfnsdutlza (ouuvcygwtx ) View more	Positive	09 Dec 2024
ASH2024 Manual	Phase 1	Multiple Myeloma	38	Anitocabtagene autoleucel (anito-cel)	(ouhejnxqil) = vxozmrgyel oxucpomcbm (gygowwxntt ) View more	Positive	09 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	Anitocabtagene autoleucel	bsfktkcgzf(xchhocnxkq) = dtzvmzudeb izhsqphlcv (drnqvnmkmr, 77 - 96) View more	-	09 Dec 2024
NCT04155749 (IMS2024 \| NEWS) Manual	Phase 1	Multiple Myeloma	38	anitocabtagene autoleucel	(uanszdqzbp) = One grade 5 adverse event (AE) of unrelated cardiac arrest attributed to a non-study drug overdose occurred post study. The most common grade 3/4 hematologic AEs (n = 38) that were not attributable to cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome were decreased neutrophil count (81.6%), anemia (57.9%), and thrombocytopenia (42.1%). Among non-hematologic AEs, the most common were hypertension (7.9%), increased aspartate aminotransferase levels (5.3%), and cellulitis (5.3%). rviykkbtzx (lmqyllmyrr )	Positive	24 Sep 2024
NCT04155749 (IMS2024 \| NEWS) Manual	Phase 1	Multiple Myeloma	38	anitocabtagene autoleucel (patients with extramedullary disease)		Positive	24 Sep 2024
NCT04155749 (EHA2024) Manual	Phase 1	Multiple Myeloma Last line	40	Anitocabtagene autoleucel (anito-cel)	(ownuhppelr) = bpvloqxuae jxnkljseev (vxwibpasqn ) View more	Positive	14 May 2024
ASH2023 Manual	Phase 1	Multiple Myeloma Last line	38	CART-ddBCMA	(mgqtkjjnbp) = pgkxafiqid rftzfwmhcj (ibjekqfoyw ) View more	Positive	11 Dec 2023
PRNewswire Manual	Phase 1	Multiple Myeloma	38	CART-ddBCMA	(oposatpgir) = qpvgpnejhn olmidsitmb (memzittybx ) View more	Positive	08 Dec 2023
ASH2022 Manual	Phase 1	Relapse multiple myeloma \| Plasma cell myeloma refractory	31	Fludarabine 30 mg/m2/day+Cyclophosphamide 300 mg/m2/day+CART-Ddbcma	(omqvmzasnz) = iqinaxuzdc djgulppvsh (uhlxzpelml ) View more	Positive	15 Nov 2022
NCT04155749 (ARC-101, ESMO2022) Manual	Phase 1	Multiple Myeloma Last line	25	CART-ddBCMA 100x10^6/300x10^6 CAR+T cells	(wmjtotmkvq) = epbuowmurs brhsvcgnyk (klywtnshpy ) View more	Positive	10 Sep 2022
NCT04155749 (ARC-101, ESMO2022) Manual	Phase 1	Multiple Myeloma Last line	25	CART-ddBCMA 100x10^6/300x10^6 CAR+T cells (DL1)	(wmjtotmkvq) = goopiitvrf brhsvcgnyk (klywtnshpy ) View more	Positive	10 Sep 2022
IMS2022	Phase 1	Relapse multiple myeloma	33	CART-ddBCMA	gpsxbfomvp(lftfhynwua) = ffjislhtdo kaivvftnyx (kegqlilkvj ) View more	Positive	25 Aug 2022

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