Paula Rodríguez Otero, MD, PhD, on Demonstrating Ide-cel's PFS Superiority in Triple-Class-Exposed R/R Multiple Myeloma
The hematologist at the University of Navarra discussed updated data from the phase KarMMa-3 trial.
“After a median follow up of 31 months, ide-cel continued to show significantly longer and clinically meaningful improvement in progression-free survival versus the standard regimens...”
Idecabtagene vicleucel (ide-cel; Bristol Myers Squibb, 2seventybio) is a BCMA-directed chimeric antigen receptor (CAR) T-cell therapy marketed under the name Abecma. It is currently FDA-approved for the treatment of patients with relapsed/refractory (r/r) multiple myeloma (MM) after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.1 Although, it is currently under clinical evaluation as a potential option for earlier lines of treatment. The ongoing phase 3 KarMMa-3 clinical trial (NCT03651128) is currently evaluating the cell therapy against standard of care (SOC) combination regimens for patients with early-line (2 to 4 prior lines) triple-class-exposed r/r MM.2
An updated analysis of progression-free survival (PFS) data from KarMMa-3 was recently presented by Paula Rodríguez Otero, MD, PhD, a hematologist at the University of Navarra, at the 2023 American Society of Hematology (ASH) Annual Meeting & Exposition, held December 9-12, in San Diego, California. The new data, which was the final analysis of PFS for the trial, demonstrated ide-cel's superiority over SOC regimens in terms of PFS for the population of treated patients.
Shortly after the close of the conference, CGTLive™ sat down with Otero to learn more about the analysis she presented. Otero gave an overview of the key data presented, noting that in addition to the PFS results she also presented interim data for overall survival, which was a secondary end point in KarMMa-3. She pointed out that although the study was not powered to give definitive results for OS and that the data was confounded by patient crossover from SOC to ide-cel use, a planned sensitivity analysis adjusting for crossover favored ide-cel over SOC for OS. Otero also touched on ide-cel's safety profile in KarMMa-3 and the importance of effective bridging therapy in CAR-T studies of this type.
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REFERENCES
1. U.S. Food and Drug Administration approves Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel), the first anti-BCMA CAR T cell therapy for relapsed or refractory multiple myeloma. News release. Bristol Myers Squibb and bluebird bio. March 26, 2021. Accessed December 14, 2023. https://bwnews.pr/39jWjjd
2. Otero PR, Ailawadhi S, Arnulf B, et al.Idecabtagene vicleucel (ide-cel) versus standard (std) regimens in patients (pts) with triple-class–exposed (TCE) relapsed and refractory multiple myeloma (RRMM): updated analysis from KarMMa-3. Presented at: ASH 2023 Annual Meeting & Exposition. December 9-12; San Diego, CA. Abstract #1028
Considerations for Administering Hemoglobinopathy Gene Therapies From a Pharmacist’s Perspective
April 20th 2024Alexis Kuhn, PharmD, BCOP, a pediatric oncology pharmacist at Mayo Clinic, discussed the incorporation of the recently FDA-approved gene therapies for SCD and TDT into the work of pharmacists.
