[Translation] Bioequivalence study of ixazomib citrate capsules after single oral administration on an empty stomach in Chinese patients with multiple myeloma

主要研究目的：观察中国多发性骨髓瘤患者空腹单剂量口服枸橼酸伊沙佐米胶囊（规格：4 mg/粒，江苏天士力帝益药业有限公司生产）后的药物体内代谢过程，以恩莱瑞®（规格：4 mg/粒，Takeda Pharma A/S生产）为参比制剂，以药代动力学参数为终点指标，评价空腹状态下口服两种制剂的生物等效性。次要研究目的：观察枸橼酸伊沙佐米胶囊在中国多发性骨髓瘤患者中的安全性。

[Translation]

Main study objectives: To observe the in vivo metabolism of ixazomib citrate capsules (specification: 4 mg/capsule, produced by Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.) after fasting single-dose oral administration in Chinese patients with multiple myeloma, and to evaluate the bioequivalence of the two oral preparations in the fasting state with Enlari® (specification: 4 mg/capsule, produced by Takeda Pharma A/S) as the reference preparation and pharmacokinetic parameters as the endpoint indicators. Secondary study objectives: To observe the safety of ixazomib citrate capsules in Chinese patients with multiple myeloma.

Start Date31 May 2024

Sponsor / Collaborator

Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

ChiCTR2400084725 / SuspendedPhase 4IIT

An open and exploratory clinical trial of ixazomib combined with melphalan/prednisone (IMP) in the treatment of elderly patients with multiple myeloma

Start Date31 May 2024

Sponsor / Collaborator

Qingdao Municipal Hospital

NCT04305691 / RecruitingPhase 2IIT

A Phase 2 Trial of Ixazomib for Kaposi Sarcoma

This phase II trial studies how well ixazomib works in treating patients with Kaposi sarcoma. Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Start Date07 Nov 2023

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Ixazomib citrate

100 Translational Medicine associated with Ixazomib citrate

100 Patents (Medical) associated with Ixazomib citrate

614

Literatures (Medical) associated with Ixazomib citrate

01 Dec 2024·EUROPEAN JOURNAL OF HAEMATOLOGY

Efficacy of ixazomib, lenalidomide, dexamethasone regimen in daratumumab‐exposed relapsed/refractory multiple myeloma patients: A retrospective analysis

Article

Author: Boichuk, Ivanna ; Krejci, Marta ; Radova, Lenka ; Fidrichova, Anna ; Ondrouskova, Eva ; Fric, Dominik ; Knechtova, Zdenka ; Sandecka, Viera ; Jarosova, Marie ; Adam, Zdenek ; Pour, Ludek ; Stork, Martin

Abstract:

We performed retrospective analysis of relapsed/refractory multiple myeloma (RRMM) patients previously exposed to daratumumab treated with ixazomib, lenalidomide, dexamethasone (IRd) regimen in real clinical practice. Our aim was to evaluate efficacy of IRd in these patients and select a subset of patients that would benefit from this treatment the most. In total, we analyzed 43 daratumumab‐exposed RRMM patients treated in our center. Minimal response or better was achieved by 53.5% of patients from the cohort. Median progression free survival (PFS) was 4.56 months (95% CI: 2.56, 8.03) and median overall survival (OS) was 28.92 months (95% CI: 5.4, NR). Duration of response (DOR) was evaluable in 28 patients and reached a median of 21.3 months (95% CI: 6.85, NR). Next, we evaluated hazard ratios (HR) for OS and PFS. There was improved OS in patients that were not‐triple refractory or worse (HR = 0.39, 95%Cl (0.14; 1.10), p = .07) and in patients, that had less than three previous lines of treatment (LOT) (HR = 0.13, 95%Cl (0.03; 0.6) p = .003). Similar to OS, there was improved PFS in patients, that were not triple‐refractory or worse (HR = 0.52, 95%Cl (0.25; 1.10), p = .08). We concluded, that the best survival benefit for RRMM patients pretreated with daratumumab to IRd regimen was observed in patients that were not triple‐refractory and had less than three previous lines of treatment (LOT). The DOR in these patients was 21.3 months (95% CI: 6.85, NR).

01 Nov 2024·DRUG DEVELOPMENT RESEARCH

Discovery of Novel SIRT3 Inhibitors for the Cancer Differentiation Therapy by Structural Modification

Article

Author: Xu, Guangzhao ; Li, Fahui ; Li, Honggang ; Du, Yanmei ; Zhang, Lihui ; Zhang, Lei ; Zhang, Daopeng

ABSTRACT:

Inhibition of SIRT3 triggered differentiation of multiple myeloma (MM) cells. In discovery of potent SIRT3 inhibitors for cancer differentiation therapy, structural modification was performed on the previously developed lead compound S27. A total of 49 compounds divided into two series were designed and synthesized. In the enzyme inhibitory assay, several molecules (A7, A13, B15, and B26) exhibited potent SIRT3 inhibitory activity and selectivity. Significantly, representative compounds, especially A7, promoted differentiation of MM cells from cancer phenotype to normal cells, accompanied by increased expression of antigen CD49e, human immunoglobulin light chain λ‐IgLG and κ‐IgLG. Additionally, molecule A7 reversed growth factor IL‐6 induced MM cell proliferation, improved the antiproliferative activity of Ixazomib and increased the apoptotic rate of MM cells treated with Ixazomib. Collectively, potent SIRT3 inhibitors with MM cell differentiation potency were developed for the cancer therapy used alone or in combination.

01 Nov 2024·Lancet Haematology

Ixazomib as consolidation and maintenance versus observation in patients with relapsed multiple myeloma eligible for salvage autologous stem-cell transplantation (Myeloma XII [ACCoRD]): interim analysis of a multicentre, open-label, randomised, phase 3 trial

Article

Author: Parrish, Christopher ; Hockaday, Anna ; Boyd, Kevin ; de Tute, Ruth ; Yong, Kwee ; Ashcroft, A John ; Garg, Mamta ; Senior, Ethan ; Owen, Roger G ; Sati, Hamdi ; Drayson, Mark T ; Snowden, John A ; Cairns, David A ; Cook, Gordon ; Olivier, Catherine ; Cavenagh, Jamie D ; Cook, Mark ; Richards, Jeanine ; Roberts, Lesley ; Gillson, Sharon

BACKGROUND:

The efficacy of consolidation and maintenance in the context of salvage autologous haematopoietic stem-cell transplantation (HSCT) for relapsed multiple myeloma remains unclear. We aimed to assess whether consolidation after salvage autologous HSCT, using ixazomib, thalidomide, and dexamethasone, followed by maintenance with single agent ixazomib is superior to observation.

METHODS:

This is an interim analysis of Myeloma XII (ACCorD; referred to as ACCorD hereafter), an open-label, randomised, controlled, phase 3 trial done at 79 hospitals in the UK. Eligible patients were aged 18 years or older, had relapsed multiple myeloma with measurable disease, an ECOG performance status of 2 or less with adequate renal, hepatobiliary, pulmonary, and cardiac function, and required treatment for first progressive disease occurring at least 12 months after first autologous HSCT. In a first randomisation, patients were assigned (1:1) to receive either conventional autologous HSCT with melphalan or augmented autologous HSCT with melphalan and ixazomib. In the second randomisation, reported here, patients were assigned (1:1) to consolidation using ixazomib, thalidomide, and dexamethasone (oral ixazomib 4 mg per day on days 1, 8, and 15, oral thalidomide 100 mg per day on days 1-28, and oral dexamethasone 40 mg per day on days 1, 8, 15 and 22 of 28-day cycles), followed by maintenance with single agent ixazomib (oral ixazomib 4 mg per day on days 1, 8, and 15 of 28-day cycles until disease progression or intolerance), or observation. The primary endpoint was progression-free survival, analysed by intention-to-treat. Safety was analysed per-protocol. This study is registered with ISRCTN, ISRCTN10038996, and EudraCT, 2016-000905-35, and recruitment is complete.

FINDINGS:

Between Dec 12, 2017, and April 21, 2023, 206 patients entered the second randomisation (103 in the consolidation and maintenance group and 103 in the observation group). This prespecified interim analysis (data cutoff April 21, 2023), was done at a median follow-up of 27 months (IQR 13-38). Median progression-free survival was 20 months (95% CI 15-29) in the consolidation and maintenance group and 13 months (11-18) in the observation group (hazard ratio 0·55 [95% CI 0·39-0·78]; p=0·0006). Serious adverse events were reported in 29 (32%) of 92 patients in the consolidation and maintenance group compared with seven (7%) of 103 patients in the observation group. The most common serious adverse events were infections and infestations in both the consolidation and maintenance group and the observation group. The most common grade 3, 4, or 5 adverse events for patients in the consolidation and maintenance group were upper respiratory infection (seven [8%] of 92 patients). No deaths in the consolidation and maintenance group were deemed treatment related.

INTERPRETATION:

ACCorD provides evidence that an orally administered, deliverable, and tolerable post-salvage autologous HSCT treatment regimen can improve the durability of response for transplantation-eligible patients at first relapse. The findings are of relevance to patients who had durable disease control from autologous HSCT in the first line, representing a viable alternative to continuous parentally-administered relapse therapies.

FUNDING:

Cancer Research UK, Takeda Oncology.

News (Medical) associated with Ixazomib citrate

17 Jul 2024

·www.prnewswire.com

Alltrna Announces Updates to Its Board of Directors

Chris Schade appointed as Board Chairperson Lynne Parshall, Robert Plenge, M.D., Ph.D., and Nancy Simonian, M.D., appointed to Board of Directors CAMBRIDGE, Mass., July 17, 2024 /PRNewswire/ -- Alltrna, a Flagship Pioneering company unlocking transfer RNA (tRNA) biology and pioneering tRNA therapeutics to regulate the protein universe and resolve disease, today announced the appointment of Chris Schade, Growth Partner at Flagship Pioneering, as Chairperson of the Board, succeeding Noubar Afeyan, Ph.D., Co-Founder of Alltrna and Founder and CEO of Flagship Pioneering. In addition, Alltrna also announced the appointments to the company's Board of Directors of Lynne Parshall, founding Chief Operating Officer of Ionis Pharmaceuticals, Robert Plenge, M.D., Ph.D., Executive Vice President, Chief Research Officer and Head of Research at Bristol Myers Squibb, and Nancy Simonian, M.D., Founding CEO of Syros Pharmaceuticals. They join Board Directors Michelle Werner, Alltrna CEO and Flagship Pioneering CEO-Partner, and Lovisa Afzelius, Ph.D., MBA, Alltrna Co-Founder and Flagship Pioneering General Partner. "As a Co-Founder of Alltrna and Board Chairperson since 2018, I've been honored to guide Alltrna from ideation to platform creation to in vivo preclinical proof-of-concept," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering and Co-Founder of Alltrna. "As Alltrna looks to bring its first tRNA medicines into the clinic, Chris' expertise in company development, partnering, and financing will be indispensable. With Chris leading the Board and the additions of Lynne, Robert, and Nancy, Alltrna is exceptionally well-positioned to fulfill this enormous opportunity leveraging the unique biology of tRNA to scale the development of genetic medicines for many diseases." "Noubar's extraordinary vision as Board Chairperson during Alltrna's critical formative years have brought us to our leadership position in the genetic medicines community today, and Chris's diverse experience and insights in helping grow biotech companies will be invaluable as we build on this momentum to pioneer tRNA medicine and further build Alltrna and its platform to support innovation and scale," added Michelle C. Werner, CEO of Alltrna and CEO-Partner of Flagship Pioneering. "I also look forward to working closely with Lynne, Robert, and Nancy and leveraging their extensive experience to advance our first universal medicine for Stop Codon Disease to the clinic." "I am honored to be Chairperson and look forward to continuing to work with Michelle and Lovisa at this pivotal time as Alltrna charts its path to clinical trials and beyond," said Chris Schade, Board Chairperson, Alltrna and Growth Partner, Flagship Pioneering. "With proof-of-concept in vivo data showing its platform can be leveraged to engineer and modify tRNAs for universal readthrough of a shared genetic mutation found in thousands of rare diseases, Alltrna is leading the field in turning tRNA's sophisticated biology into scalable genetic medicines. I am also thrilled to welcome Lynne, Robert, and Nancy to Alltrna's Board of Directors. Their diverse expertise spanning all aspects of drug development, from translational research to operations and strategy, will serve Alltrna well as the company advances this completely new class of RNA medicines." Christian S. Schade Mr. Schade has more than 30 years of private and public pharmaceutical and biotechnology industry experience, as well as broad corporate finance expertise from his tenure in investment banking. Prior to Flagship, he served as the Chairman and CEO of Aprea Therapeutics Inc. (NASDAQ: APRE), a clinical-stage biopharmaceutical company. Prior to Aprea, Schade's previous roles include CEO of Novira (acquired by Johnson & Johnson), Executive Vice President (EVP) and Chief Financial Officer (CFO) of Omthera Pharmaceuticals, Inc. (NASDAQ: OMTH, acquired by AstraZeneca Plc), EVP and CFO at NRG Energy Inc. (NYSE: NRG), and Senior Vice President of Administration and CFO at Medarex, Inc. (NASDAQ: MEDX, acquired by Bristol Myers Squibb). Before Medarex, Schade served as Managing Director at Merrill Lynch in London and held various corporate finance and capital markets positions in New York and London for both Merrill Lynch and JP Morgan Chase & Co. Schade currently serves as Chair of the Board of Directors of Omega Therapeutics, Inc. (NASDAQ: OMGA), and serves on the Boards of Ring Therapeutics, Valo Health, and Integra LifeSciences Inc. (NASDAQ:IART), where he chairs the Audit and Finance Committees. Lynne Parshall Ms. Parshall is a seasoned biotechnology leader with more than 35 years in industry. An attorney by training, she spent more than 30 years as the founding Chief Operating Officer of Ionis Pharmaceuticals and subsequently as a Strategic Advisor to the CEO, overseeing legal, finance, business development, portfolio management, strategic planning, manufacturing, regulatory, alliance management, and other functions. While at Ionis she was responsible for raising more than $6 billion in financing from equity-based securities and corporate partner transactions. Ms. Parshall has sat on numerous public and private company Boards of Directors and has extensive Audit Committee and corporate governance experience. She currently is on the Boards of Ionis Pharmaceuticals (NASDAQ: IONS), Cytokinetics (NASDAQ: CYTK), Foghorn Therapeutics (NASDAQ: FHTX), Ring Therapeutics, Repertoire Immune Medicines, and Celdara Medical. She was previously Chair of the Board of Akcea Therapeutics prior to its acquisition. Prior to working in industry, she was a partner at the Cooley law firm with a practice focusing on securities law and biotechnology corporate partnering. Robert Plenge, M.D., Ph.D. Dr. Plenge is Executive Vice President, Chief Research Officer and Head of Research at Bristol Myers Squibb (BMS). He leads scientific activities across eleven research sites around the world all focused on transforming patients' lives through science. Prior to his current role, Dr. Plenge served as head of Discovery & Translational Sciences at BMS, which spanned all therapeutic areas at the company. He joined BMS as part of the acquisition of Celgene in November 2019. At Celgene, he served as Vice President, Immunology & Inflammation portfolio, Research & Early Development. Prior to joining Celgene, Dr. Plenge was Vice President and Head of Translational Medicine at Merck. Prior to his roles in industry, he was an Assistant Professor of Medicine at Harvard Medical School and an Associate Member of the Broad Institute while practicing clinical rheumatology and running a research laboratory at Brigham & Women's Hospital. Dr. Plenge is an author of more than 125 manuscripts published in peer-reviewed journals and a recipient of several academic and corporate awards. He currently serves on the Board of Directors for the PhRMA Foundation. Nancy Simonian, M.D. Dr. Simonian is a physician-scientist who has dedicated her career to developing drugs for people with serious diseases. She is the Founding CEO and a member of the Board of Directors of Syros Pharmaceuticals, a biopharmaceutical company committed to advancing novel approaches to treating cancer based on altering gene expression. Prior to Syros, she was Chief Medical Officer at Millennium Pharmaceuticals and Vice President of Clinical Development at Biogen. At Millennium, Dr. Simonian oversaw the successful development of VELCADE® to treat multiple myeloma, and mantle cell lymphoma, NINLARO® to treat multiple myeloma and ENTYVIO® to treat inflammatory bowel disease. At Biogen, she played a central role in developing AVONEX® and TYSABRI® for multiple sclerosis. Dr. Simonian started her career as an assistant professor at Harvard Medical School and Massachusetts General Hospital. She currently serves as a Director of Syros (NASDAQ: SYRS) and the Damon Runyon Cancer Research Foundation. She previously served as a Director of Seagen (NASDAQ: SGEN; acquired by Pfizer in 2023), Evelo (NASDAQ: EVLO), and ArQule (NASDAQ: ARQL; acquired by Merck in 2020). About Stop Codon Disease Stop Codon Disease encompasses thousands of rare and common diseases that stem from premature termination codons (PTC) also called nonsense mutations, where the code for an amino acid has been mutated into a premature "stop" codon. This results in a truncated or shortened protein product with no or altered biological activity that causes disease. Approximately 10% of all people with a genetic disease have Stop Codon Disease, representing approximately 30 million people worldwide. Alltrna is engineering tRNA medicines that can read these PTC mutations and deliver the desired amino acid, thereby restoring the production of the full-length protein. About Alltrna Alltrna unlocks tRNA biology to treat disease. The company's platform incorporates AI/ML tools to develop and deliver diverse programmable molecules with broad therapeutic potential. Alltrna has an unprecedented opportunity to advance a single tRNA medicine to readthrough premature stop codons and unify treatment across a wide range of diseases with the same underlying genetic mutations. Alltrna was founded in 2018 by Flagship Pioneering. For more info, visit . About Flagship Pioneering Flagship Pioneering invents and builds bioplatform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $75 billion in aggregate value. To date, Flagship has deployed over $3.8 billion in capital toward the founding and growth of its pioneering companies alongside more than $27 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 40 companies, including Foghorn Therapeutics (NASDAQ: FHTX), Moderna (NASDAQ: MRNA), Sana Biotechnology (NASDAQ: SANA), Generate Biomedicines, Inari, Indigo Agriculture, and Tessera Therapeutics. Media Contacts Jessica Yingling, Ph.D., Little Dog Communications Inc., [email protected], +1.858.344.8091 Josephine Zorbo, Ph.D., Flagship Pioneering, [email protected] SOURCE Alltrna

Executive ChangeAcquisition

31 May 2024

·www.globenewswire.com

Adaptive Biotechnologies Announces Data Supporting the Clinical Benefits of MRD Assessment with clonoSEQ® To Be Presented at the Upcoming 2024 ASCO Annual Meeting and EHA2024 Hybrid Congress

More than 20 abstracts will be presented from clinical trials and real-world evidence using clonoSEQ for MRD assessment across multiple types of blood cancersSEATTLE, May 31, 2024 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in several oral and poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4 in Chicago and at the European Hematology Association (EHA) Hybrid Congress taking place June 13-16 in Madrid and virtually. “The data that will be presented at ASCO and EHA this year build on the expansive evidence base supporting the clinical significance and actionability of MRD testing with clonoSEQ within the quickly evolving blood cancer treatment landscape,” said Susan Bobulsky, chief commercial officer, MRD, Adaptive Biotechnologies. “clonoSEQ continues to be the gold standard in MRD assessment, empowering clinicians with the most reliable insights to navigate complex treatment decisions and arming drug developers with a highly sensitive and standardized assay to confidently advance the most promising therapeutics.” MRD status is a powerful predictor of outcomes in blood cancers. Routine MRD testing offers a personalized approach to monitor and evaluate an individual’s response to treatment, identify early signs of relapse before symptoms occur, and inform shared decision-making to optimize care. Beyond clinical applications, clonoSEQ assay technology is used extensively in drug development as a robustly validated tool to understand treatment efficacy and determine depth and kinetics of response. It is also increasingly being used as a primary endpoint in clinical trials. The clinical trial data and real-world evidence to be presented at ASCO and EHA further underscore the clinical benefit of specific and sensitive MRD assessment with clonoSEQ. Highlights include: In a Children’s Oncology Group-led study of pediatric patients with acute lymphoblastic leukemia (ALL), evidence from the largest analysis to date comparing bone marrow MRD assessment to peripheral blood MRD assessment with clonoSEQ showed a strong correlation between blood and marrow, independent of patient risk group. These data support the potential for a less invasive method to monitor MRD and track a patient’s response to therapy in ALL.In various stages of multiple myeloma (MM), real-world evidence and clinical trial results reinforced the clinical significance of sustained MRD negativity and importance of depth of response in predicting patient outcomes, including overall survival (OS) and progression-free survival (PFS), and illustrated how clonoSEQ could inform treatment discontinuation or de-escalation decisions. Follow-up data generated from the University of Chicago prospective MRD2STOP study indicated that MRD testing with clonoSEQ at 10–6 may help identify patients who can safely and effectively discontinue maintenance therapy and sustain MRD negativity off treatment.An MRD analysis from the PERSEUS study, conducted by the Cancer Center Clinica Universidad de Navarra in Spain, compared bortezomib/lenalidomide/dexamethasone (VRd) with or without daratumumab (D) in transplant-eligible patients with newly diagnosed MM. MRD negativity at both 10–5 and 10–6 was associated with improved PFS. Of note, the higher rates of deeper responses (10–6) in the D-VRd/D-R arm were associated with a clinically meaningful benefit of improved PFS.Multiple trials evaluating the safety and efficacy of novel chimeric antigen receptor T cell (CAR-T) therapies demonstrated the value of utilizing clonoSEQ to measure deep responses during or after therapy in often difficult-to-treat patient populations and showed MRD negativity as assessed by clonoSEQ testing is associated with PFS. In patients with chronic lymphocytic leukemia (CLL), data from clinical trials highlighted the use of clonoSEQ to support individualized MRD-guided treatment modification. clonoSEQ-related data to be presented at both ASCO and EHA: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaASCO Oral Presentation6504Obecabtagene Autoleucel (Obe-Cel, AUTO1) In Adults With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): Overall Survival (OS), Event-Free Survival (EFS) And The Potential Impact Of Chimeric Antigen Receptor (CAR)-T Cell Persistency And Consolidative Stem Cell Transplantation (SCT) In The Open-Label, Single-Arm FELIX Phase Ib/II StudyFriday, May 313:57–4:09 p.m. CDTEHA Oral PresentationS114Obecabtagene Autoleucel In Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia: Survival And Potential Impact Of CAR-T Cell Persistence And Stem Cell Transplantation In The FELIX StudyFriday, June 143:45–4 p.m. CESTMultiple MyelomaASCO Oral Presentation7505Efficacy And Safety Of Ciltacabtagene Autoleucel ± Lenalidomide Maintenance In Newly Diagnosed Multiple Myeloma With Suboptimal Response To Frontline Autologous Stem Cell Transplant: CARTITUDE-2 Cohort DMonday, June 34:24–4:36 p.m. CDTEHA Oral PresentationS205Ciltacabtagene Autoleucel ± Lenalidomide Maintenance In Newly Diagnosed Multiple Myeloma With Suboptimal Response To Frontline Autologous Stem Cell Transplant: CARTITUDE-2 Cohort DSaturday, June 154:30–4:45 p.m. CESTASCO Oral Presentation7510Efficacy Of Venetoclax-Dexamethasone (Vendex) V Pomalidomide-Dexamethasone (Pomdex) In Patients (Pts) With T(11;14)-Positive Relapsed/Refractory Multiple Myeloma [T(11;14)+ RRMM]: Phase 3 CANOVA Study Biomarker Subgroup AnalysisMonday, June 34:24–4:36 p.m. CDTEHA Poster PresentationP912Efficacy Of Venetoclax-Dexamethasone V Pomalidomide-Dexamethasone In Patients With T(11;14)-Positive Relapsed/Refractory Multiple Myeloma [T(11;14)+ RRMM]:Phase 3 CANOVA Biomarker Subgroup AnalysisFriday, June 146 p.m. CESTASCO Oral Presentation7502Daratumumab (DARA) + Bortezomib/Lenalidomide/Dexamethasone (VRd) In Transplant-Eligible (TE) Patients (Pts) With Newly Diagnosed Multiple Myeloma (NDMM): Analysis Of Minimal Residual Disease (MRD) In the PERSEUS TrialMonday, June 33:24–3:36 p.m. CDTEHA Oral PresentationS201Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma: Analysis of Minimal Residual Disease in the PERSEUS TrialSaturday, June 1511:45 a.m.–12 p.m. CESTASCO Oral Presentation7504Ciltacabtagene Autoleucel Vs Standard of Care in Patients With Functional High-Risk Multiple Myeloma: CARTITUDE-4 Subgroup AnalysisMonday, June 34:12–4:24 p.m. CDTEHA Poster PresentationP978Ciltacabtagene Autoleucel Vs Standard of Care in Lenalidomide-Refractory Multiple Myeloma: Phase 3 CARTITUDE-4 Subgroup Analysis By Cytogenetic RiskFriday, June 146 p.m. CEST Additional data to be presented at ASCO: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaOral Presentation10014Comparison Of Immunoglobulin High-Throughput Sequencing MRD in Bone Marrow And Peripheral Blood In Pediatric B-ALL: A Report From The Children's Oncology Group AALL1731Monday, June 312:54–1:06 p.m. CDTFollicular LymphomaOral Presentation7015EPCORE NHL1 Follicular Lymphoma (FL) Cycle (C) 1 Optimization (OPT) Cohort: Expanding The Clinical Utility of Epcoritamab in Relapsed o-r Refractory (R/R) FLSunday, June 25:30–5:36 p.m. CDTMultiple MyelomaOral Presentation106Discontinuation of Maintenance Therapy in Multiple Myeloma Guided By Multimodal Measurable Residual Disease Negativity (MRD2STOP)Monday, June 310:01–10:13 a.m. CDTOral Presentation7500Phase 3 Study Results of Isatuximab, Bortezomib, Lenalidomide, And Dexamethasone (Isa-Vrd) Versus Vrd For Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma (IMROZ)Monday, June 33–3:12 p.m. CDTOral Presentation7501Phase 3 Randomized Study of Isatuximab (Isa) Plus Lenalidomide And Dexamethasone (Rd) With Bortezomib Versus Isard in Patients With Newly Diagnosed Transplant Ineligible Multiple Myeloma (NDMM TI)Monday, June 33:12–3:24 p.m. CDTPoster Presentation7527Association Of Patient (Pt) Factors And Pharmacodynamic Biomarkers With Progression-Free Survival (PFS) After Idecabtagene Vicleucel (Ide-Cel) In Pts From KarMMa-3Monday, June 39 a.m.–12 p.m. CDTPoster Presentation7535Ciltacabtagene Autoleucel In Patients With Lenalidomide-Refractory Multiple Myeloma: CARTITUDE-2 Cohort A Expansion SubgroupMonday, June 39 a.m.–12 p.m. CDTPoster Presentation7557Effect Of Dose-Adjusted Melphalan On MRD-Negativity To Full Dose Melphalan in Patients With Multiple Myeloma Post-Autologous Stem Cell TransplantMonday, June 39 a.m.–12 p.m. CDTPoster Presentation7560Indirect Comparison of Linvoseltamab Versus Teclistamab For Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM)Monday, June 39 a.m.–12 p.m. CDT Additional data to be presented at EHA: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaPoster PresentationP413Brexucabtagene Autoleucel (Brexu-Cel) As Consolidation Treatment in Adults With B-Cell Acute Lymphoblastic Leukemia With Marrow Blasts <5%, Including Patients (Pts) With NGS MRD Negative DiseaseFriday, June 146 p.m. CESTChronic Lymphocytic LeukemiaOral PresentationS164Combined Pirtobrutinib, Venetoclax, And Obinutuzumab in First-Line Treatment of Patients With Chronic Lymphocytic Leukemia (CLL): A Phase 2 TrialFriday, June 143:45–4 p.m. CESTPoster Presentation P1837Postinfusion Resource Use And Cost of Lisocabtagene Maraleucel By Response Status And Prior Lines of Therapy In Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia From TRANSCEND CLL 004Friday, June 146 p.m. CESTPoster PresentationP672A Phase 2 Study of Minimal Residual Disease (MRD)-Adapted, Time-Limited Acalabrutinib And Obinutuzumab For The Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL): MRD OutcomesFriday, June 146 p.m. CESTFollicular LymphomaOral PresentationS234Epcoritamab Induces Deep Responses in Relapsed Or Refractory (R/R) Follicular Lymphoma (FL): Safety And Pooled Efficacy Data From EPCORE NHL‑1 Pivotal And Cycle (C) 1 Optimization (OPT) FL CohortsSaturday, June 155:30–5:45 p.m. CESTPoster Presentation P1137Undetectable Measurable Residual Disease (MRD) Is Associated With Improved Long-Term Outcome in Patients With Follicular Lymphoma (FL) Treated With Chemo-Immunotherapy: Results From SWOG S0016Friday, June 146 p.m. CESTPoster PresentationP2059Minimal Residual Disease (MRD), Pharmacokinetic (PK), And Pharmacodynamic (PD) Assessment of Epcoritamab 2- Vs 3-Step Step-Up Dosing in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL)Friday, June 146 p.m. CESTMultiple MyelomaPoster Presentation P974Daratumumab (DARA)/Bortezomib/Lenalidomide/Dexamethasone (D-VRd) With D-R Maintenance (Maint) In Transplant-Eligible (TE) Newly Diagnosed Myeloma (NDMM): Analysis of PERSEUS Based On Cytogenetic RiskFriday, June 146 p.m. CESTPoster Presentation P943Oral Ixazomib Maintenance Following Autologous Stem Cell Transplant (ASCT) In Patients With Newly Diagnosed Multiple Myeloma (NDMM): Final Overall Survival (OS) Analysis From The TOURMALINE-MM3 StudyFriday, June 146 p.m. CEST About clonoSEQ clonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test service to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) patients is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle, WA. clonoSEQ leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, ALL, and DLBCL. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary. About Adaptive BiotechnologiesAdaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. Forward Looking Statements This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections regarding the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. ADAPTIVE INVESTORSKarina Calzadilla, Vice President, Investor Relations201-396-1687investors@adaptivebiotech.com ADAPTIVE MEDIAErica Jones, Associate Corporate Communications Director206-279-2423media@adaptivebiotech.com

ASCOClinical ResultPhase 2ImmunotherapyCell Therapy

31 May 2024

·www.biospace.com

Adaptive Biotechnologies Announces Data Supporting the Clinical Benefits of MRD Assessment with clonoSEQ® To Be Presented at the Upcoming 2024 ASCO Annual Meeting

SEATTLE, May 31, 2024 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in several oral and poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4 in Chicago and at the European Hematology Association (EHA) Hybrid Congress taking place June 13-16 in Madrid and virtually. “The data that will be presented at ASCO and EHA this year build on the expansive evidence base supporting the clinical significance and actionability of MRD testing with clonoSEQ within the quickly evolving blood cancer treatment landscape,” said Susan Bobulsky, chief commercial officer, MRD, Adaptive Biotechnologies. “clonoSEQ continues to be the gold standard in MRD assessment, empowering clinicians with the most reliable insights to navigate complex treatment decisions and arming drug developers with a highly sensitive and standardized assay to confidently advance the most promising therapeutics.” MRD status is a powerful predictor of outcomes in blood cancers. Routine MRD testing offers a personalized approach to monitor and evaluate an individual’s response to treatment, identify early signs of relapse before symptoms occur, and inform shared decision-making to optimize care. Beyond clinical applications, clonoSEQ assay technology is used extensively in drug development as a robustly validated tool to understand treatment efficacy and determine depth and kinetics of response. It is also increasingly being used as a primary endpoint in clinical trials. The clinical trial data and real-world evidence to be presented at ASCO and EHA further underscore the clinical benefit of specific and sensitive MRD assessment with clonoSEQ. Highlights include: In a Children’s Oncology Group-led study of pediatric patients with acute lymphoblastic leukemia (ALL), evidence from the largest analysis to date comparing bone marrow MRD assessment to peripheral blood MRD assessment with clonoSEQ showed a strong correlation between blood and marrow, independent of patient risk group. These data support the potential for a less invasive method to monitor MRD and track a patient’s response to therapy in ALL. In various stages of multiple myeloma (MM), real-world evidence and clinical trial results reinforced the clinical significance of sustained MRD negativity and importance of depth of response in predicting patient outcomes, including overall survival (OS) and progression-free survival (PFS), and illustrated how clonoSEQ could inform treatment discontinuation or de-escalation decisions. Follow-up data generated from the University of Chicago prospective MRD2STOP study indicated that MRD testing with clonoSEQ at 10–6 may help identify patients who can safely and effectively discontinue maintenance therapy and sustain MRD negativity off treatment. An MRD analysis from the PERSEUS study, conducted by the Cancer Center Clinica Universidad de Navarra in Spain, compared bortezomib/lenalidomide/dexamethasone (VRd) with or without daratumumab (D) in transplant-eligible patients with newly diagnosed MM. MRD negativity at both 10–5 and 10–6 was associated with improved PFS. Of note, the higher rates of deeper responses (10–6) in the D-VRd/D-R arm were associated with a clinically meaningful benefit of improved PFS. Multiple trials evaluating the safety and efficacy of novel chimeric antigen receptor T cell (CAR-T) therapies demonstrated the value of utilizing clonoSEQ to measure deep responses during or after therapy in often difficult-to-treat patient populations and showed MRD negativity as assessed by clonoSEQ testing is associated with PFS. In patients with chronic lymphocytic leukemia (CLL), data from clinical trials highlighted the use of clonoSEQ to support individualized MRD-guided treatment modification. clonoSEQ-related data to be presented at both ASCO and EHA: Presentation Type and Number Title Presentation Timing B-Cell Acute Lymphoblastic Leukemia ASCO Oral Presentation 6504 Obecabtagene Autoleucel (Obe-Cel, AUTO1) In Adults With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): Overall Survival (OS), Event-Free Survival (EFS) And The Potential Impact Of Chimeric Antigen Receptor (CAR)-T Cell Persistency And Consolidative Stem Cell Transplantation (SCT) In The Open-Label, Single-Arm FELIX Phase Ib/II Study Friday, May 31 3:57–4:09 p.m. CDT EHA Oral Presentation S114 Obecabtagene Autoleucel In Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia: Survival And Potential Impact Of CAR-T Cell Persistence And Stem Cell Transplantation In The FELIX Study Friday, June 14 3:45–4 p.m. CEST Multiple Myeloma ASCO Oral Presentation 7505 Efficacy And Safety Of Ciltacabtagene Autoleucel ± Lenalidomide Maintenance In Newly Diagnosed Multiple Myeloma With Suboptimal Response To Frontline Autologous Stem Cell Transplant: CARTITUDE-2 Cohort D Monday, June 3 4:24–4:36 p.m. CDT EHA Oral Presentation S205 Ciltacabtagene Autoleucel ± Lenalidomide Maintenance In Newly Diagnosed Multiple Myeloma With Suboptimal Response To Frontline Autologous Stem Cell Transplant: CARTITUDE-2 Cohort D Saturday, June 15 4:30–4:45 p.m. CEST ASCO Oral Presentation 7510 Efficacy Of Venetoclax-Dexamethasone (Vendex) V Pomalidomide-Dexamethasone (Pomdex) In Patients (Pts) With T(11;14)-Positive Relapsed/Refractory Multiple Myeloma [T(11;14)+ RRMM]: Phase 3 CANOVA Study Biomarker Subgroup Analysis Monday, June 3 4:24–4:36 p.m. CDT EHA Poster Presentation P912 Efficacy Of Venetoclax-Dexamethasone V Pomalidomide-Dexamethasone In Patients With T(11;14)-Positive Relapsed/Refractory Multiple Myeloma [T(11;14)+ RRMM]:Phase 3 CANOVA Biomarker Subgroup Analysis Friday, June 14 6 p.m. CEST ASCO Oral Presentation 7502 Daratumumab (DARA) + Bortezomib/Lenalidomide/Dexamethasone (VRd) In Transplant-Eligible (TE) Patients (Pts) With Newly Diagnosed Multiple Myeloma (NDMM): Analysis Of Minimal Residual Disease (MRD) In the PERSEUS Trial Monday, June 3 3:24–3:36 p.m. CDT EHA Oral Presentation S201 Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma: Analysis of Minimal Residual Disease in the PERSEUS Trial Saturday, June 15 11:45 a.m.–12 p.m. CEST ASCO Oral Presentation 7504 Ciltacabtagene Autoleucel Vs Standard of Care in Patients With Functional High-Risk Multiple Myeloma: CARTITUDE-4 Subgroup Analysis Monday, June 3 4:12–4:24 p.m. CDT EHA Poster Presentation P978 Ciltacabtagene Autoleucel Vs Standard of Care in Lenalidomide-Refractory Multiple Myeloma: Phase 3 CARTITUDE-4 Subgroup Analysis By Cytogenetic Risk Friday, June 14 6 p.m. CEST Additional data to be presented at ASCO: Presentation Type and Number Title Presentation Timing B-Cell Acute Lymphoblastic Leukemia Oral Presentation 10014 Comparison Of Immunoglobulin High-Throughput Sequencing MRD in Bone Marrow And Peripheral Blood In Pediatric B-ALL: A Report From The Children's Oncology Group AALL1731 Monday, June 3 12:54–1:06 p.m. CDT Follicular Lymphoma Oral Presentation 7015 EPCORE NHL1 Follicular Lymphoma (FL) Cycle (C) 1 Optimization (OPT) Cohort: Expanding The Clinical Utility of Epcoritamab in Relapsed o-r Refractory (R/R) FL Sunday, June 2 5:30–5:36 p.m. CDT Multiple Myeloma Oral Presentation 106 Discontinuation of Maintenance Therapy in Multiple Myeloma Guided By Multimodal Measurable Residual Disease Negativity (MRD2STOP) Monday, June 3 10:01–10:13 a.m. CDT Oral Presentation 7500 Phase 3 Study Results of Isatuximab, Bortezomib, Lenalidomide, And Dexamethasone (Isa-Vrd) Versus Vrd For Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma (IMROZ) Monday, June 3 3–3:12 p.m. CDT Oral Presentation 7501 Phase 3 Randomized Study of Isatuximab (Isa) Plus Lenalidomide And Dexamethasone (Rd) With Bortezomib Versus Isard in Patients With Newly Diagnosed Transplant Ineligible Multiple Myeloma (NDMM TI) Monday, June 3 3:12–3:24 p.m. CDT Poster Presentation 7527 Association Of Patient (Pt) Factors And Pharmacodynamic Biomarkers With Progression-Free Survival (PFS) After Idecabtagene Vicleucel (Ide-Cel) In Pts From KarMMa-3 Monday, June 3 9 a.m.–12 p.m. CDT Poster Presentation 7535 Ciltacabtagene Autoleucel In Patients With Lenalidomide-Refractory Multiple Myeloma: CARTITUDE-2 Cohort A Expansion Subgroup Monday, June 3 9 a.m.–12 p.m. CDT Poster Presentation 7557 Effect Of Dose-Adjusted Melphalan On MRD-Negativity To Full Dose Melphalan in Patients With Multiple Myeloma Post-Autologous Stem Cell Transplant Monday, June 3 9 a.m.–12 p.m. CDT Poster Presentation 7560 Indirect Comparison of Linvoseltamab Versus Teclistamab For Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM) Monday, June 3 9 a.m.–12 p.m. CDT Additional data to be presented at EHA: Presentation Type and Number Title Presentation Timing B-Cell Acute Lymphoblastic Leukemia Poster Presentation P413 Brexucabtagene Autoleucel (Brexu-Cel) As Consolidation Treatment in Adults With B-Cell Acute Lymphoblastic Leukemia With Marrow Blasts <5%, Including Patients (Pts) With NGS MRD Negative Disease Friday, June 14 6 p.m. CEST Chronic Lymphocytic Leukemia Oral Presentation S164 Combined Pirtobrutinib, Venetoclax, And Obinutuzumab in First-Line Treatment of Patients With Chronic Lymphocytic Leukemia (CLL): A Phase 2 Trial Friday, June 14 3:45–4 p.m. CEST Poster Presentation P1837 Postinfusion Resource Use And Cost of Lisocabtagene Maraleucel By Response Status And Prior Lines of Therapy In Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia From TRANSCEND CLL 004 Friday, June 14 6 p.m. CEST Poster Presentation P672 A Phase 2 Study of Minimal Residual Disease (MRD)-Adapted, Time-Limited Acalabrutinib And Obinutuzumab For The Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL): MRD Outcomes Friday, June 14 6 p.m. CEST Follicular Lymphoma Oral Presentation S234 Epcoritamab Induces Deep Responses in Relapsed Or Refractory (R/R) Follicular Lymphoma (FL): Safety And Pooled Efficacy Data From EPCORE NHL‑1 Pivotal And Cycle (C) 1 Optimization (OPT) FL Cohorts Saturday, June 15 5:30–5:45 p.m. CEST Poster Presentation P1137 Undetectable Measurable Residual Disease (MRD) Is Associated With Improved Long-Term Outcome in Patients With Follicular Lymphoma (FL) Treated With Chemo-Immunotherapy: Results From SWOG S0016 Friday, June 14 6 p.m. CEST Poster Presentation P2059 Minimal Residual Disease (MRD), Pharmacokinetic (PK), And Pharmacodynamic (PD) Assessment of Epcoritamab 2- Vs 3-Step Step-Up Dosing in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL) Friday, June 14 6 p.m. CEST Multiple Myeloma Poster Presentation P974 Daratumumab (DARA)/Bortezomib/Lenalidomide/Dexamethasone (D-VRd) With D-R Maintenance (Maint) In Transplant-Eligible (TE) Newly Diagnosed Myeloma (NDMM): Analysis of PERSEUS Based On Cytogenetic Risk Friday, June 14 6 p.m. CEST Poster Presentation P943 Oral Ixazomib Maintenance Following Autologous Stem Cell Transplant (ASCT) In Patients With Newly Diagnosed Multiple Myeloma (NDMM): Final Overall Survival (OS) Analysis From The TOURMALINE-MM3 Study Friday, June 14 6 p.m. CEST About clonoSEQ clonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test service to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) patients is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle, WA. clonoSEQ leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, ALL, and DLBCL. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit . About Adaptive Biotechnologies Adaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. Forward Looking Statements This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections regarding the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. ADAPTIVE INVESTORS Karina Calzadilla, Vice President, Investor Relations 201-396-1687 investors@adaptivebiotech.com ADAPTIVE MEDIA Erica Jones, Associate Corporate Communications Director 206-279-2423 media@adaptivebiotech.com

Clinical ResultASCOPhase 3Phase 2Cell Therapy

100 Deals associated with Ixazomib citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D10131	Ixazomib citrate	L01XX50	DB09570

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Myeloma	US	Takeda Pharmaceuticals U.S.A., Inc.	20 Nov 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plasmacytoma	Phase 3	US	Biologics, Inc.	01 Dec 2015
Plasmacytoma	Phase 3	US	Millennium Pharmaceuticals, Inc.	01 Dec 2015
Spondylocarpotarsal Synostosis	Phase 3	US	Takeda Pharmaceutical (China) Co. Ltd.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	US	Millennium Pharmaceuticals, Inc.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	US	Haupt Pharma Amareg GmbH	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	JP	Takeda Pharmaceutical (China) Co. Ltd.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	JP	Millennium Pharmaceuticals, Inc.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	JP	Haupt Pharma Amareg GmbH	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	AR	Millennium Pharmaceuticals, Inc.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	AR	Haupt Pharma Amareg GmbH	17 Mar 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	Multiple Myeloma	-	Ixazomib-lenalidomide-dexamethasone (IRd)	toltgnqsjz(zllhdjxsrx) = Any grade TEAEs reported in ≥25% of pts were diarrhea (26%) in the 1−3 cycles group; PN not elsewhere classified (NEC; 34%), fatigue (34%), diarrhea (34%), and edema NEC (26%) in the 4−9 cycles group; and diarrhea (68%), PN NEC (53%), fatigue (42%), edema NEC (38%), arthralgia (35%), nausea (33%), and back pain (29%) in the >9 cycles group. oclfoucvto (yoqnoixzam ) View more	-	09 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	Ixazomib	nfxjyscsod(xexayjztbk) = chxgytncxl hsnihchagp (yduaokggev ) View more	-	08 Dec 2024
				Lenalidomide	nfxjyscsod(xexayjztbk) = zwzosjjuys hsnihchagp (yduaokggev ) View more
NCT02004275 (Alliance A061202, Pubmed \| Blood Adv) Manual	Phase 2	Relapse multiple myeloma	30	Ixazomib, Pomalidomide, Dexamethasone	cfwdeisxue(tysvnikxxx) = More hematologic toxicities were seen with the triplet therapy zylblpcade (lxzclrfakn ) View more	Positive	08 Oct 2024
				Pomalidomide, Dexamethasone
NCT03941860 (CTgov)	Phase 3	Residual Neoplasm \| Multiple Myeloma	1	Bone Marrow Biopsy+Lenalidomide+Ixazomib Citrate (Arm A (Lenalidomide, Ixazomib Citrate))	gqbkmyggoq(ytgkrjwrgd) = lvtkbcvbzi txulzpjyby (kfcebrymaw, vydcidwcub - johkqgpgwt) View more	-	01 Aug 2024
				Bone Marrow Biopsy+Lenalidomide (Arm B (Lenalidomide, Placebo))	gqbkmyggoq(ytgkrjwrgd) = nkygzclnba txulzpjyby (kfcebrymaw, ppsfgrdyei - thiutnjekx) View more
NCT04998786 (I2D, ASCO2024)	Phase 2	Relapse multiple myeloma	70	Iberdomide	abieyamanv(zsthppxebt) = ggzwgvsxip vumlhagdbr (zhyyrzumnp ) View more	Positive	24 May 2024
				Ixazomib	rujlxvpjzb(gsviijzqvc) = cmzhwasqyn xgtonipkup (moaffwtcoh )
NCT03457142 (CTgov)	Phase 2	Recurrent Multiple Myeloma \| Refractory Multiple Myeloma	15	Laboratory Biomarker Analysis+Abatacept+Ixazomib Citrate+Dexamethasone	eellzfuovt(odzutltwvp) = ooushhnwfz tdudwcwilh (zycoptwpbt, jiqsalvfup - hssvcluhuw) View more	-	16 May 2024
NCT02181413 (TOURMALINE-MM3, EHA2024) Manual	Phase 3	Multiple Myeloma Maintenance \| First line	656	Ixazomib	jksdozeeke(ordcwnhctx) = dwwnhchagn eskfufrkex (owkxowlnrp ) View more	Negative	14 May 2024
				Placebo	jksdozeeke(ordcwnhctx) = shklsckvqu eskfufrkex (owkxowlnrp ) View more
NCT03683277 (IFM2014-01, EHA2024) Manual	Phase 2	Multiple Myeloma	26	IXAZOMIB+POMALIDOMIDE+DEXAMETHASONE	sphnzohbaa(llhveszxev) = kcrsxphihw ldjsgtbpfk (uxqqkvdsnx, 4.4 - NR) View more	Positive	14 May 2024
EHA2024	Not Applicable	Multiple Myeloma Maintenance FISH high-risk group \| standard-risk group	121	Ixazomib maintenance therapy	uljvcobbue(cvsjdddzsp) = agfdjiogne oyhcrsdstr (zqkzhptbit )	Positive	14 May 2024
				Lenalidomide maintenance therapy	uljvcobbue(cvsjdddzsp) = xysjuyfbfz oyhcrsdstr (zqkzhptbit )
EHA2024	Not Applicable	Multiple Myeloma \| Peripheral Nervous System Diseases rs2839629 \| rs915854	126	Ixazomib	uthksbbvdw(gzjuonqsfv) = qygcrnykih lwvlwjggni (uuswrxxnkp ) View more	-	14 May 2024
				Ixazomib-dexamethasone	uthksbbvdw(gzjuonqsfv) = nrhvjbebfv lwvlwjggni (uuswrxxnkp ) View more

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