Aankondiging • Apr 06

U.S. Fda Approves Bristol Myers Squibb and 2Seventy Bio’S Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy

Bristol-Myers Squibb Company and 2seventy bio, Inc. have announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma®(idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial. This approval expands Abecma’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy. Abecma is administered as a one-time infusion, with a new recommended dose range of 300 to 510 x 106 CAR-positive T cells. Please see the Important Safety Information section below, including Boxed WARNINGS for Abecma regarding Cytokine Release Syndrome, Neurologic Toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome, Prolonged Cytopenia, and Secondary Hematological Malignancies. Despite advances in treatment, multiple myeloma remains an incurable disease characterized by periods of remission and relapse. In early lines of treatment, regimens consisting of combinations of IMiDs, PIs, and anti-CD38 monoclonal antibodies are often used to help manage the disease. Unfortunately, as many patients go on to relapse and/or become refractory to these classes of therapy, more patients are becoming triple-class exposed earlier in their treatment journey. There are limited options for these patients, and triple-class exposed relapsed and/or refractory multiple myeloma is associated with poor outcomes and a median progression-free survival (PFS) of three to five months. In this patient population with high unmet need, Abecma has demonstrated clinically meaningful and statistically significant improvements in PFS (95% CI: 13.3 months vs. 4.4 months [HR: 0.49; p<0.0001]). In addition, Abecma exhibited a well-established safety profile with mostly low-grade cytokine release syndrome and neurotoxicity. No cases of Parkinsonism were reported in the study. To support this approval and future expansions, Bristol Myers Squibb has made continuous investments to increase manufacturing capacity and has shown a consistently high manufacturing success rate of 94% for Abecma in the commercial setting. Abecma was recently approved in Japan, Switzerland and the European Union for adult patients with triple-class exposed relapsed and/or refractory multiple myeloma after two prior lines of therapy, making it the only CAR T cell therapy available globally for earlier lines of therapy for patients with triple-class exposed relapsed and/or refractory multiple myeloma. Abecma is also currently approved in Great Britain and Israel for adult patients with triple-class exposed relapsed and refractory multiple myeloma after three or more prior lines of therapy. The KarMMa-3 trial is a pivotal, Phase 3, open-label, global, randomized, controlled trial evaluating Abecma compared to standard regimens in patients with relapsed and refractory multiple myeloma who have received two to four prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and were refractory to the last treatment regimen, with 94% of patients with disease refractory to prior treatment with daratumumab. KarMMa-3 is the only Phase 3 trial to evaluate a CAR T cell therapy in a patient population consisting entirely of triple-class exposed relapsed and refractory multiple myeloma patients. The trial’s patient-centric design allowed for crossover from standard regimens to Abecma upon confirmed disease progression. At the time of the final progression-free survival (PFS) analysis, more than half (56%) of patients in the standard regimens arm crossed over to receive Abecma as a subsequent therapy. In the study, 254 patients were randomized to receive Abecma and 132 were randomized to receive standard regimens that consisted of combinations that included daratumumab, pomalidomide, and dexamethasone (DPd), daratumumab, bortezomib, and dexamethasone (DVd), ixazomib, lenalidomide, and dexamethasone (IRd), carfilzomib and dexamethasone (Kd) or elotuzumab, pomalidomide and dexamethasone (EPd) chosen based on their most recent treatment regimen and investigator discretion. In the Abecma arm, pretreatment consisted of leukapheresis and optional bridging therapy. The choice to use bridging therapy was at the discretion of the investigator.

Aankondiging • Dec 13

Bristol Myers Squibb and 2seventy bio, Inc. Announce Results from the Preplanned Final Progression-Free Survival Analysis of KarMMa-3

Bristol Myers Squibb and 2seventy bio, Inc. announced results from the preplanned final progression-free survival (PFS) analysis of KarMMa-3, the pivotal Phase 3, open-label, global, randomized controlled study evaluating Abecma (idecabtagene vicleucel) compared with standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (triple-class exposed), who were refractory to their last regimen. At a median follow-up of 30.9 months (range: 12.7-47.8), representing the longest follow-up for a randomized Phase 3 CAR T cell therapy trial in this patient population, significantly improved PFS was maintained with Abecma compared to standard regimens (95% CI: 13.8 months vs. 4.4 months), with a 51% reduction in the risk of disease progression or death (HR: 0.49; 95% CI: 0.38-0.63). These data are being presented on December 11, 2023 in an oral presentation at the 65thAmerican Society of Hematology (ASH) Annual Meeting and Exposition. With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens. The ORR with Abecma was 71% (95% CI: 66-77) with a complete response (CR) rate of 44% (95% CI: 38-50), which increased by 5% from the interim analysis. In comparison, the ORR for standard regimens was 41% (95% CI: 34-51), with a CR rate of 5% (95% CI: 2-9), which remained unchanged from the time of interim analysis. The PFS, ORR and CR rates observed in the KarMMa-3 trial in the standard regimens arm are consistent with those that have historically been observed in this heavily pre-treated triple-class exposed patient population, in which PFS is approximately four months and deep and durable responses are limited. With these data, Abecma is the first and only anti-BCMA CAR T cell therapy to demonstrate superiority over standard regimens in a randomized, controlled Phase 3 trial designed to evaluate patients with triple-class exposed relapsed and refractory multiple myeloma. In the study, which included a patient-centric design that allowed for crossover from standard regimens to Abecma upon confirmed disease progression, overall survival (OS) was a key secondary endpoint. Due to the median PFS observed with standard regimens, more than half (56%) of patients in the standard regimens arm crossed over to receive Abecma as a subsequent therapy. The median OS was 41.4 months with Abecma (95% CI: 30.9-NR) and 37.9 months with standard regimens (95% CI: 23.4-NR) (95% CI: 0.73-1.40; HR: 1.01). However, the prespecified sensitivity analyses adjusting for crossover showed a median OS of 41.4 months for Abecma (95% CI: 30.9-NR) and 23.4 months (95% CI: 17.9-NR) for standard regimens (95% CI: 0.45-1.09; HR: 0.69), suggesting a positive trend in OS benefit for Abecma compared with standard regimens. Historically, based on real-world evidence, median OS for patients with triple-class exposed relapsed and refractory multiple myeloma is approximately 13 months. In the KarMMa-3 study, Abecma continued toexhibit a well-established and generally predictable safety profile, including no new safety signals, with mostly low-grade occurrences of cytokine release syndrome (CRS) and neurotoxicity. In patients treated with Abecma with extended follow-up, occurrences of CRS and neurologic toxicities remained consistent with the interim analysis with88% of patients experiencing any grade CRS, and Grade 3/4 CRS events occurring in 4% of patients. Two patients (1%) experienced a Grade 5 CRS event. Any grade neurotoxicity occurred in 15% of patients, with Grade 3/4 neurotoxicity occurring in 3% of patients, and no Grade 5 events reported. Results from extended follow-up for Cohort 2c of the multicohort, Phase 2, multicenter KarMMa-2 study, evaluating Abecma in patients with multiple myeloma who had an inadequate response to frontline therapy with autologous stem cell transplantation (ASCT) are also being presented in a poster presentation at the meeting. At data cutoff with a median follow-up of 39.4 months, the ORR in patients treated with Abecma (n=31) was 87.1% (95% CI: 70.2-96.4), with a CR rate of 77.4% (95% CI: 58.9-90.4). Abecma is the first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy approved by the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Please see the Important Safety Information section below, including Boxed WARNINGS for Abecma regarding CRS, neurologic toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome and Prolonged Cytopenia. Abecma is also approved in the European Union, Switzerland, Canada, the United Kingdom and Israel for adult patients with triple-class exposed relapsed or refractory multiple myeloma after three to four or more prior lines of therapy. KarMMa-3 (NCT03651128) is a pivotal, Phase 3, open-label, global, randomized, controlled trial evaluating Abecma compared to standard regimens in patients with relapsed and refractory multiple myeloma who have received two to four prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and were refractory to the last treatment regimen. Patients were randomized to receive Abecma or standard regimens that consisted of combinations that included daratumumab, pomalidomide, and dexamethasone (DPd), daratumumab, bortezomib, and dexamethasone (DVd), ixazomib, lenalidomide, and dexamethasone (IRd), carfilzomib and dexamethasone (Kd) or elotuzumab, pomalidomide and dexamethasone (EPd) chosen based on their most recent treatment regimen and investigator discretion. The primary endpoint evaluated in this study is progression-free survival (PFS), defined as time from randomization to the first documentation of progressive disease or death due to any cause, whichever occurs first. Key secondary endpoints include overall response rate (ORR) and overall survival (OS). KarMMa-2 (NCT03601078) is a Phase 2, open-label, multicohort, multicenter study evaluating the efficacy and safety of Abecma in patients with relapsed and refractory multiple myeloma (Cohort 1), patients with multiple myeloma that has progressed within 18 months of initial treatment including autologous stem cell transplantation (ASCT) (Cohort 2a), or without ASCT (Cohort 2b) or, in patients with inadequate response post-ASCT during initial treatment (Cohort 2c), and patients with newly diagnosed multiple myeloma with suboptimal response to ASCT (Cohort 3).

Biotechs Groei van de industrie	17.04%
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Bedrijfsanalyse	2025/05/15 22:53
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Recente prestatie-updates uit het verleden

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