[Translation] A Phase III, multicenter, randomized, open-label study comparing ABBV-383 with existing standard of care in subjects with relapsed or refractory multiple myeloma (3rd-line and beyond RRMM monotherapy study)

评估 ABBV-383 单药疗法在既往至少接受过 2 线治疗（包括接受过蛋白酶体抑制剂 [PI]、免疫调节酰亚胺 [IMiD] 和抗 CD38 单克隆抗体 [mAb] 治疗）的复发性/难治性 (R/R) 多发性骨髓瘤 (MM) 成人受试者中的疗效、安全性和耐受性。

[Translation]

To evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy in adult subjects with relapsed/refractory (R/R) multiple myeloma (MM) who have received at least 2 prior lines of therapy, including treatment with a proteasome inhibitor [PI], an immunomodulatory imide [IMiD], and an anti-CD38 monoclonal antibody [mAb].

Start Date14 Aug 2024

Sponsor / Collaborator

AbbVie Deutschland GmbH & Co. KG

[+2]

NCT06223516 / RecruitingPhase 1

A Multicenter, Phase 1b, Open-label Study of ABBV-383 Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety and pharmacokinetics of ABBV-383 in adult participants with relapsed/refractory (R/R) MM.
ABBV-383 is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 25 sites across the world
In Arm A participants will receive one of two doses of ABBV-383 as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Start Date17 Jun 2024

Sponsor / Collaborator

AbbVie, Inc.

NCT06158841 / RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Open Label Study of ABBV-383 Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of ABBV-383 compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM.
ABBV-383 is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. . In Arm A, participants will receive ABBV-383 as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world.
In Arm A participants will receive ABBV-383 as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Start Date19 May 2024

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Etentamig

100 Translational Medicine associated with Etentamig

100 Patents (Medical) associated with Etentamig

Literatures (Medical) associated with Etentamig

01 Nov 2024·Clinical Lymphoma Myeloma & Leukemia

Comprehensive Review of Bispecific Antibody Constructs In Multiple Myeloma: Affinities, Dosing Strategies and Future Perspectives

Review

Author: Rasche, Leo ; Einsele, Hermann ; Waldschmidt, Johannes M ; Kortüm, K Martin

Despite significant advancements, multiple myeloma (MM) remains incurable, and there is still a pressing need for new therapeutic strategies with highly selective mechanisms of action and balanced off-target toxicity. In recent years, the development of "off-the-shelf" bispecific antibodies (bsAbs) has significantly enhanced our ability to treat relapsed or refractory MM. Teclistamab, elranatamab (both BCMA × CD3), and talquetamab (GPRC5D × CD3) are approved for treating MM patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Meanwhile, the range of available bsAbs is rapidly expanding, offering patients and healthcare providers a broad selection of options that vary in target antigens, binding domains, construct designs, dosing regimens, and side effects. As linvoseltamab, alnuctamab, and ABBV-383 (all BCMA × CD3), as well as forimtamig (GPRC5D × CD3) and cevostamab (FcRH5 × CD3) progress through late-stage clinical development, emerging trispecific antibodies are now available that target either 2 different MM-associated antigens or provide additional co-stimulatory signals to prevent T-cell exhaustion. Despite this plethora of therapeutic options, resistance to bsAbs is an inevitability, and the optimal positioning of these drugs within the current MM treatment landscape remains to be determined. In this review, we examine the available data on all clinically accessible bsAbs, evaluating their potential, current limitations, and implications for efficacy and safety, with the aim of achieving deeper responses and longer overall survival for MM patients.

02 Nov 2022·Cancer discovery

ABBV-383 Demonstrates Tolerability and Efficacy in Relapsed/Refractory MM

Article

Abstract:

The T cell–engaging bispecific antibody ABBV-383 was well tolerated in relapsed/refractory multiple myeloma (RRMM).

01 Nov 2022·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen × CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma

Article

Author: Kumar, Shaji ; Lee, Shane ; Bueno, Orlando F. ; Yue, Susan ; Rodriguez, Cesar ; Voorhees, Peter M. ; Vij, Ravi ; Freise, Kevin J. ; D'Souza, Anita ; Talati, Chetasi ; Weisel, Katja ; Polepally, Akshanth R. ; Jin, Ziyi ; Shah, Nina ; Buelow, Ben ; Ross, Jeremy A. ; Pothacamury, Rajvineeth K.

PURPOSE:

ABBV-383, a B-cell maturation antigen × CD3 T-cell engaging bispecific antibody, has demonstrated promising results in an ongoing first-in-human phase I study (ClinicalTrials.gov identifier: NCT03933735 ) in patients with relapsed/refractory multiple myeloma (RRMM). Herein, we report safety and efficacy outcomes of this phase I dose escalation/expansion study.

METHODS:

Patients with RRMM (≥ three prior lines including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody) were eligible. ABBV-383 was administered intravenously over 1-2 hours once every 3 weeks, without any step dosing. A 3 + 3 design with backfilling for dose escalation was used (intrapatient escalation to highest safe dose permitted) followed by initiation of dose expansion.

RESULTS:

As of January 8, 2022, 124 patients (dose escalation [0.025-120 mg], n = 73; dose expansion [60 mg], n = 51) have received ABBV-383; median age was 68 years (range, 35-92 years). The most common hematologic treatment-emergent adverse events (TEAEs) were neutropenia (all grades: 37%) and anemia (29%). The most common nonhematologic TEAEs were cytokine release syndrome (57%) and fatigue (30%). Seven deaths from TEAEs were reported with all considered unrelated to study drug by the investigator. For all efficacy-evaluable patients (n = 122; all doses), the objective response rate (ORR) was 57% and very good partial response (VGPR) or better (≥ VGPR) rate was 43%. In the 60 mg dose expansion cohort (n = 49), the ORR and ≥ VGPR rates were 59% and 39%, respectively; and in the ≥ 40 mg dose escalation plus dose expansion cohorts (n = 79) were 68% and 54%, respectively.

CONCLUSION:

ABBV-383 in patients with RRMM was well tolerated with an ORR of 68% at doses ≥ 40 mg. This novel therapy's promising preliminary antitumor activity in heavily pretreated patients warrants further clinical evaluation.

News (Medical) associated with Etentamig

31 Oct 2024

·endpts.com

AbbVie adds to T cell engager momentum, with EvolveImmune pact starting at $65M

AbbVie, already a leader in the T cell engager field with Epkinly and a Phase 3 program, is further digging into the field with a new discovery collaboration with EvolveImmune Therapeutics. The Chicago pharmaceutical company will pay EvolveImmune $65 million in upfront payments and equity, and it could dish out up to $1.4 billion in biobucks and fees if it elects to license the programs. The tie-up will focus on solid tumors and hematologic malignancies. The partnership is further validation of the R&D at EvolveImmune, which has raised about $72 million to date from VC investors as well as Bristol Myers Squibb and the corporate venture arms of Pfizer and Takeda. “There’s a next generation of T cell engagers, which we’re part of, that can bend the curve on treating patients,” EvolveImmune CEO Stephen Bloch told Endpoints News . He said the industry is “just at the beginning of that wave.” The deal arrives amid a week stacked with TCE-related deals and partnerships. GSK announced it’s paying $300 million upfront to buy an oncology T cell engager from Chimagen that it plans to study in lupus next year, and Genmab lined up a partnership with Revitope Oncology in solid tumors. Earlier this year, Merck paid $700 million for a Curon asset , Candid Therapeutics raised $370 million and Clasp Therapeutics nabbed $150 million. AbbVie is no stranger to T cell engagers. With Genmab, it markets the lymphoma treatment Epkinly. And in June, it also entered Phase 3 with another TCE, named ABBV-383. The money from AbbVie will help EvolveImmune get its lead internal program, named EVOLVE-104, into the clinic by the middle of next year, according to Bloch. The company likely won’t raise another private funding round before that Phase 1 but is open to additional financing in the future, he said. EvolveImmune has built a co-stimulatory molecule into its programs, which activates CD2, to improve durability. Bloch said T cell engagement through CD3 alone is “not enough” and leads to exhaustion and dysfunction of the T cells. “It’s a system, rather than folks who are thinking about multiple therapies or exogenous or multiple antibodies, to try to get to the same place,” Bloch said. Putting T cell engagers in studies for patients with autoimmune diseases has also become a focus in recent deals. Bloch said the company has a CD20 program that could be applied in autoimmune indications but will likely wait to see how other autoimmune TCEs read out in 2025. He’s not ruling out partnerships on the autoimmune front, though. “There’s a lot of competition,” he said, “and there’s also a lot of watching and seeing.” The startup, which has nearly 40 employees, previously did CRISPR/Cas9 discovery work in the CAR-T space. “The CAR-Ts obviously are incredibly important, but the T cell engagers open up cancer therapies to a much broader set of patients who may not be at academic medical centers,” Bloch said. He also pointed to the “very, very high” costs of administering CAR-Ts to patients.

Phase 3Cell Therapy

25 Jul 2024

·www.prnewswire.com

AbbVie Reports Second-Quarter 2024 Financial Results

Reports Second-Quarter Diluted EPS of $0.77 on a GAAP Basis, a Decrease of 32.5 Percent; Adjusted Diluted EPS of $2.65, a Decrease of 8.9 Percent; These Results Include an Unfavorable Impact of $0.52 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Second-Quarter Net Revenues of $14.462 Billion, an Increase of 4.3 Percent on a Reported Basis and 5.6 Percent on an Operational Basis Second-Quarter Global Net Revenues from the Immunology Portfolio Were $6.971 Billion, an Increase of 2.3 Percent on a Reported Basis, or 3.5 Percent on an Operational Basis; Global Humira Net Revenues Were $2.814 Billion; Global Skyrizi Net Revenues Were $2.727 Billion; Global Rinvoq Net Revenues Were $1.430 Billion Second-Quarter Global Net Revenues from the Oncology Portfolio Were $1.634 Billion, an Increase of 10.5 Percent on a Reported Basis, or 12.2 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $833 Million; Global Venclexta Net Revenues Were $637 Million Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.162 Billion, an Increase of 14.7 Percent on a Reported Basis, or 15.2 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $814 Million; Global Vraylar Net Revenues Were $774 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $381 Million Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.390 Billion, an Increase of 0.5 Percent on a Reported Basis, or 2.8 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $729 Million; Global Juvederm Net Revenues Were $343 Million Raises 2024 Adjusted Diluted EPS Guidance Range from $10.61 - $10.81 to $10.71 - $10.91, which Includes an Unfavorable Impact of $0.60 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2024 NORTH CHICAGO, Ill., July 25, 2024 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2024. "Our business continues to perform exceptionally well, with second quarter results meaningfully ahead of our expectations," said Robert A. Michael, chief executive officer, AbbVie. "Based upon the significant momentum of our ex-Humira growth platform, our continued investments in the business and our pipeline progress, we are very well positioned to deliver our top-tier long-term outlook." Second -Quarter Results Worldwide net revenues were $14.462 billion, an increase of 4.3 percent on a reported basis, or 5.6 percent on an operational basis. Global net revenues from the immunology portfolio were $6.971 billion, an increase of 2.3 percent on a reported basis, or 3.5 percent on an operational basis. Global Humira net revenues of $2.814 billion decreased 29.8 percent on a reported basis, or 28.9 percent on an operational basis. U.S. Humira net revenues were $2.360 billion, a decrease of 31.6 percent. Internationally, Humira net revenues were $454 million, a decrease of 18.9 percent on a reported basis, or 12.5 percent on an operational basis. Global Skyrizi net revenues were $2.727 billion, an increase of 44.8 percent on a reported basis, or 45.6 percent on an operational basis. Global Rinvoq net revenues were $1.430 billion, an increase of 55.8 percent on a reported basis, or 59.2 percent on an operational basis. Global net revenues from the oncology portfolio were $1.634 billion, an increase of 10.5 percent on a reported basis, or 12.2 percent on an operational basis. Global Imbruvica net revenues were $833 million, a decrease of 8.2 percent, with U.S. net revenues of $595 million and international profit sharing of $238 million. Global Venclexta net revenues were $637 million, an increase of 11.5 percent on a reported basis, or 15.8 percent on an operational basis. Global Elahere net revenues were $128 million. Global net revenues from the neuroscience portfolio were $2.162 billion, an increase of 14.7 percent on a reported basis, or 15.2 percent on an operational basis. Global Botox Therapeutic net revenues were $814 million, an increase of 8.7 percent on a reported basis, or 9.6 percent on an operational basis. Global Vraylar net revenues were $774 million, an increase of 17.6 percent. Global Ubrelvy net revenues were $231 million, an increase of 17.5 percent. Global Qulipta net revenues were $150 million, an increase of 56.3 percent. Global net revenues from the aesthetics portfolio were $1.390 billion, an increase of 0.5 percent on a reported basis, or 2.8 percent on an operational basis. Global Botox Cosmetic net revenues were $729 million, an increase of 6.4 percent on a reported basis, or 8.6 percent on an operational basis. Global Juvederm net revenues were $343 million, a decrease of 6.8 percent on a reported basis, or 3.1 percent on an operational basis. On a GAAP basis, the gross margin ratio in the second quarter was 70.9 percent. The adjusted gross margin ratio was 85.2 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 23.3 percent of net revenues. The adjusted SG&A expense was 22.9 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 13.5 percent of net revenues. The adjusted R&D expense was 13.3 percent of net revenues. Acquired IPR&D and milestones expense was 6.5 percent of net revenues. On a GAAP basis, the operating margin in the second quarter was 27.6 percent. The adjusted operating margin was 42.6 percent. Net interest expense was $506 million. On a GAAP basis, the tax rate in the quarter was 36.0 percent. The adjusted tax rate was 18.8 percent. Diluted EPS in the second quarter was $0.77 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.65. These results include an unfavorable impact of $0.52 per share related to acquired IPR&D and milestones expense. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Recent Events As previously announced, Robert A. Michael assumed the role of chief executive officer (CEO) and has joined AbbVie's Board of Directors, effective July 1, 2024. Mr. Michael succeeds Richard A. Gonzalez, who served as CEO since the company's inception in 2013. Mr. Gonzalez has become executive chairman of the board of directors. AbbVie announced the U.S. Food and Drug Administration (FDA) approved Skyrizi (risankizumab) for adults with moderately to severely active ulcerative colitis (UC). AbbVie also announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Skyrizi for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy. The FDA approval and positive CHMP opinion are based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that evaluated the efficacy and safety of Skyrizi in adults with moderately to severely active UC. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. AbbVie announced that it submitted applications for a new indication to the FDA and EMA for Rinvoq (upadacitinib) for the treatment of adult patients with giant cell arteritis (GCA). The regulatory submissions are supported by results from the SELECT-GCA Phase 3 study evaluating the safety and efficacy of Rinvoq in patients with GCA. At the 2024 Digestive Disease Week (DDW) Annual Meeting, AbbVie presented 15 abstracts, including three oral presentations, reinforcing AbbVie's commitment to advancing the standards of care in inflammatory bowel diseases (IBD). Highlights included data from the SEQUENCE head-to-head trial comparing Skyrizi versus Stelara (ustekinumab) in Crohn's disease (CD), as well as presentations that included efficacy and safety data evaluating clinical, endoscopic, and histologic outcomes from both the INSPIRE Phase 3 induction study and the COMMAND Phase 3 maintenance study of Skyrizi as a therapy for adults with moderately to severely active UC. AbbVie announced that it completed its acquisition of Landos Biopharma. The transaction adds the first-in-class investigational asset, ABBV-113 (NX-13), to AbbVie's pipeline, which has the potential to offer a novel approach to the treatment of UC and CD. AbbVie and FutureGen Biopharmaceutical announced a license agreement to develop FG-M701, a next generation anti-TL1A antibody for the treatment of IBD, currently in preclinical development. FG-M701 is uniquely engineered with potential best-in-class functional characteristics compared to first-generation anti-TL1A antibodies, with the goal to drive greater efficacy and less frequent dosing as a therapy for IBD. AbbVie announced the acquisition of Celsius Therapeutics, a privately held biotechnology company pioneering new therapies for patients with inflammatory disease. Celsius' lead investigational asset is CEL383, a potential first-in-class anti-TREM1 antibody for the treatment of IBD that has completed a Phase 1 clinical study. AbbVie announced the FDA approved Epkinly (epcoritamab) to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of prior therapy. AbbVie also announced that the EMA's CHMP adopted a positive opinion for Tepkinly (epcoritamab) for the treatment of adults with r/r FL. The FDA approval and positive CHMP opinion are based on results from the Phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of Epkinly/Tepkinly in adult patients with r/r FL. Epkinly/Tepkinly is being co-developed by AbbVie and Genmab. AbbVie announced positive topline results from the Phase 2 PICCOLO trial evaluating Elahere (mirvetuximab soravtansine) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The trial met its primary endpoint with an objective response rate (ORR) of 51.9% and demonstrated a median duration of response (DOR), a key secondary endpoint, of 8.25 months. The safety profile of Elahere was consistent with findings from previous studies, and no new safety concerns were identified. Full data from the PICCOLO study will be presented at a future medical meeting. AbbVie announced the start of the Phase 3 CERVINO clinical trial which will evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy compared with standard available therapies (SATs) in patients with r/r multiple myeloma (MM) who have received at least two lines of prior therapy. The start of the CERVINO trial marks an important step forward in AbbVie's continued commitment to advance new oncology treatments and elevate the standard of care for blood cancer patients. At the American Society of Clinical Oncology (ASCO) Annual Meeting, AbbVie showcased its solid tumor pipeline with new data from its innovative antibody-drug conjugate (ADC) platform. Highlights included new safety and efficacy data from a Phase 1 study of ABBV-400, a next-generation, potential best-in-class c-Met directed ADC, in patients with metastatic colorectal cancer (CRC); data from a first-in-human study of ABBV-706, a potential best-in-class SEZ6 directed ADC, in small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine neoplasms (NENs); data from the primary analysis of the Phase 2 LUMINOSITY trial evaluating Telisotuzumab vedotin (Teliso-V), a potential first-in-class c-Met directed ADC, in advanced non-small cell lung cancer (NSCLC); and data from the Phase 3 MIRASOL trial of Elahere in patients with platinum-resistant ovarian cancer (PROC) and high FRα expression. AbbVie announced it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). In its letter, the FDA cited observations that were identified during inspection of a third-party manufacturer listed in the NDA. The CRL did not identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device, and does not request that AbbVie conduct additional efficacy or safety trials related to the drug or device-related testing. AbbVie continues to work with the FDA to bring ABBV-951 to patients in the U.S. as quickly as possible. AbbVie and Gilgamesh Pharmaceuticals announced a collaboration and option-to-license agreement to develop next-generation therapies for psychiatric disorders. These next-generation therapies known as neuroplastogens target mechanisms that have shown potential to provide significant clinical benefits and are designed to minimize the challenging effects seen with first-generation compounds. This collaboration will leverage AbbVie's expertise in psychiatry and Gilgamesh's innovative research platform to discover novel neuroplastogens. Full-Year 2024 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2024 from $10.61 - $10.81 to $10.71 - $10.91, which includes an unfavorable impact of $0.60 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2024. The company's 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2024, as both cannot be reliably forecasted. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our second-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2024 and 2023 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks related to the proposed acquisition of Cerevel Therapeutics, including the possibility that the acquisition may not be consummated on the anticipated timeframe or at all, risks related to the ability to realize the anticipated benefits of the proposed acquisition on the anticipated timeframe or at all, risks that the costs to consummate the proposed acquisition or to obtain the anticipated benefits of the proposed acquisition could be greater than expected, the risk that an event occurs that could give rise to the right of AbbVie, on the one hand, or Cerevel Therapeutics, on the other hand, to terminate the acquisition agreement for such transaction, the risk that the business will not be integrated successfully, disruption from the proposed acquisition making it more difficult to maintain business and operational relationships, the diversion of management's attention from ongoing business operations and opportunities, negative effects of the consummation of the proposed acquisition on business or employee relationships or the market price of the Company's common stock and/or operating results, significant transaction costs, the assumption of unknown liabilities, the risk of litigation and/or regulatory actions related to the proposed acquisition of Cerevel Therapeutics's business, risks related to the financing of the proposed acquisition, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's and Cerevel Therapeutics's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information; Item 1A, "Risk Factors," of Cerevel Therapeutics's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that Cerevel Therapeutics subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie

Phase 1Clinical ResultPhase 3Phase 2Drug Approval

05 Jun 2024

·www.prnewswire.com

AbbVie Advances Oncology Pipeline With Start of Multiple Myeloma Phase 3 Clinical Trial for Investigational Asset ABBV-383

ABBV-383 is a B-cell maturation antigen (BCMA) bispecific antibody T-cell engager being evaluated in relapsed/refractory multiple myeloma (r/r MM) The CERVINO Phase 3 trial will evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy compared with standard available therapies (SATs) in patients with r/r MM who have received at least two lines of prior therapy NORTH CHICAGO, Ill., June 5, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the first patient has been treated with investigational ABBV-383 in the CERVINO Phase 3 study. ABBV-383 is a distinctive B-cell maturation antigen (BCMA) and CD3 bispecific antibody T-cell engager composed of bivalent BCMA-binding domains allowing for high BCMA-avidity and a low-affinity CD3 binding domain.1 ABBV-383 is being evaluated in a Phase 3, multicenter, randomized, open-label study compared with standard available therapies in patients with r/r MM who received at least two lines of prior therapy. "Despite notable advances in treatment, most patients with multiple myeloma will eventually relapse. Patients with advanced disease, especially in the community setting, often have limited access to novel treatment options and existing options have a high treatment burden, including frequent dosing," said Dr. Peter Voorhees, clinical professor of medicine, director of plasma cell disorders, Atrium Health Levine Cancer Institute. "The CERVINO Phase 3 trial is designed to evaluate the efficacy of ABBV-383 with monthly dosing and we look forward to seeing the data as it emerges." Multiple myeloma is a blood cancer characterized by abnormal proliferation of plasma cells, which can cause end-organ damage and is the second most commonly occurring blood cancer in the world.2 An estimated 176,000 people globally were diagnosed with multiple myeloma in 2020, and 117,000 people died from the disease.3 "The start of the CERVINO Phase 3 trial marks an important step forward in AbbVie's continued commitment to advance new oncology treatments and elevate the standard of care for blood cancer patients," said Mariana Cota Stirner, M.D., vice president, therapeutic area head oncology, hematology, AbbVie. "ABBV-383 is being evaluated with monthly dosing from the beginning of treatment, with the goal of maximizing treatment simplicity for physicians and patients, if proven in the clinical trials." About the CERVINO Study CERVINO (NCT06158841) is a global, Phase 3, multicenter, randomized, open-label, parallel-group study evaluating ABBV-383 in adult patients (≥18 years) with r/r MM and an Eastern Cooperative Oncology Group performance status ≤2 who received at least two prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb. Patients who received prior BCMA-targeted therapy will be excluded. Patients will be randomized 1:1 to receive intravenous ABBV-383 60mg Q4W or the investigator's choice of SAT (carfilzomib + dexamethasone, elotuzumab + pomalidomide + dexamethasone, or selinexor + bortezomib + dexamethasone), and will continue treatment until confirmed progressive disease or other discontinuation criteria are met. The dual primary end points are progression-free survival and overall response rate. Secondary end points include overall survival, complete response (CR) or better, very good partial response or better, rate of minimum residual disease negativity, and change in disease symptoms and physical functioning. Approximately 140 sites globally will enroll approximately 380 total patients. Additional information about the study can be found at under the identifier NCT06158841. About ABBV-383 ABBV-383 is an investigational distinctive BCMA x CD3 bispecific antibody T-cell engager composed of bivalent high-avidity BCMA-binding domains, a low-affinity CD3-binding domain designed to reduce cytokine release, and a silenced Fc tail designed for an extended half-life that may support once every 4-week (Q4W) dosing. Clinical relevance of these structure activity relationships has not been established. BCMA is highly expressed on the surface of malignant plasma cells in multiple myeloma, making it an ideal target for therapy. BCMA plays a crucial role in the survival of myeloma cells by promoting their growth and inhibiting their apoptosis (programmed cell death).4 About AbbVie in Oncology At AbbVie, we are committed to transforming standards of care for patients living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities including Antibody Drug Conjugates (ADCs), Immuno-Oncology, and bi-specific and CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio is comprised of approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit us at . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 1 Foureau DM, Bhutani M, Robinson M, et al: Ex vivo efficacy of BCMA-bispecific antibody TNB-383B in relapsed/refractory multiple myeloma. EJHaem 1:113-121, 2020 2 International Myeloma Foundation. What is Multiple Myeloma? 3 Cancer.Net. Multiple Myeloma: Statistics. . 4 Cho SF, Anderson KC, Tai YT: Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. Front Immunol 9:1821, 2018 SOURCE AbbVie

Phase 3ImmunotherapyASCO

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Myeloma	Phase 3	CZ	AbbVie, Inc.	19 May 2024
Multiple Myeloma	Phase 3	GB	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	US	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	CN	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	JP	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	AU	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	AT	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	BE	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	DK	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	FR	AbbVie, Inc.	19 May 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03933735 (ASCO2024)	Phase 1	Relapse multiple myeloma sBCMA \| IL-6 \| IL-8 ... View more	-	ABBV-383 20 mg Q3W	eylvojcxwv(lmycomjjka) = 89% reduction of CD8+ T cells from periphery eensdnrbgt (xpfglqzjea ) View more	Positive	24 May 2024
				ABBV-383 40 mg Q3W
NCT06158841 \| NCT03933735 (ASCO2024)	Phase 1	Relapse multiple myeloma BCMA- \| CD3	220	ABBV-383 20 mg Q3W	pvtfizkslv(fpxfexcrkg) = dsagmnfugg jhodhfnjvm (vgrbplxnts ) View more	Positive	24 May 2024
				ABBV-383 40 mg Q3W	pvtfizkslv(fpxfexcrkg) = lnjlktraml jhodhfnjvm (vgrbplxnts ) View more
NCT03933735 (ASCO2024)	Phase 1	Relapse multiple myeloma	220	ABBV-383 60mg Q4W	ohkiwynctd(lchcnxtmvq) = qpecbhykwf cpnqwbveyt (zuvpjokcfk ) View more	Positive	24 May 2024
				ABBV-383 40mg Q3W	ohkiwynctd(lchcnxtmvq) = bondeganro cpnqwbveyt (zuvpjokcfk ) View more
NCT03933735 (phase 1 trial, EHA2024)	Phase 1	Relapse multiple myeloma BCMA \| CD3	220	ABBV-383 60mg Q4W	obpvdtlkoi(shpxyuboso) = cuvfzscdla fkispdmpyo (wxjdccbcrx ) View more	Positive	14 May 2024
				ABBV-383 40mg Q3W	obpvdtlkoi(shpxyuboso) = sdhrkxgxfj fkispdmpyo (wxjdccbcrx ) View more
NCT03933735 (Phase 1 Study, ASH2023)	Phase 1	Relapse multiple myeloma	220	ABBV-383 20 mg	uzseinxqhw(zhzoslgria) = qrpedujcwj txrapnqmlp (wofqioqoly ) View more	-	10 Dec 2023
				ABBV-383 40 mg	uzseinxqhw(zhzoslgria) = hyeufvgqhp txrapnqmlp (wofqioqoly ) View more
IMS2023	Phase 1	Relapse multiple myeloma BCMA-positive \| CD3	-	ABBV-383	sqpitgyztf(jxwmvgdesa) = anemia (29%) sbxklmlhgf (phqddwgzfv ) View more	-	26 Sep 2023
NCT03933735 (Pubmed) Manual	Phase 1	Relapse multiple myeloma Last line	128	ABBV-383 (ESC+EXP)	rtpjdpglxc(eqbhckrkjo) = dbabuksoxj bwgherckeb (fmlllmlajr ) View more	Positive	27 Aug 2022
				ABBV-383 (EXP)	rtpjdpglxc(eqbhckrkjo) = dgijmcdfoj bwgherckeb (fmlllmlajr ) View more
NCT03933735 (IMS2022)	Phase 1	Relapse multiple myeloma	124	ABBV-383	vmjwftxiys(wmpkgskqng) = Among pts treated at 60mg (n=60; ESC+EXP), CRS occurred in 72% of the pts (48% G1; 22% G2; 2% G3) with the first dose, with median time to onset and resolution of 1 day (0% recurrence). Other AEs observed in >20% of all pts are fatigue (30%; G3-4, 1%), anemia (29%; G3-4, 16%), nausea (29%; G3-4, 2%), diarrhea (27%; G3-4, 2%), vomiting (24%; G3-4, 0%), and neutrophil count decreased (22%; G3-4, 19%) blmikgbnoo (gqvgtwfcvu ) View more	-	25 Aug 2022

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