The approval expands the prior indication of idecabtagene vicleucel (Abecma; Bristol Myers Squibb), which will make the drug available to patients in earlier lines.
The FDA has approved idecabtagene vicleucel (Abecma; Bristol Myers Squibb) for the treatment of relapsed or refractory multiple myeloma in adults who received 2 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The approval expands the drug’s prior indication, which will make the drug available to patients in earlier lines, according to a press release from the company.1
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“[Idecabtagene vicleucel] has demonstrated a progression-free survival benefit 3 times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the promise of cell therapy to patients earlier in their treatment journey,” Bryan Campbell, senior vice president of Head of Commercial in Cell Therapy at Bristol Myers Squibb, said in a press release. “This approval underpins our commitment to addressing the unmet needs of more patients living with multiple myeloma by improving upon the current treatment paradigm, and we remain steadfast in our pursuit of innovation and advancing cell therapy research to deliver potentially transformative therapies.”1
The approval was based on the KarMMa-3 trial, an open-label, randomized, controlled phase 3 trial that evaluated the drug against standard regimens for the treatment of individuals who had received 2 to 4 prior lines of therapy for relapsed or refractory multiple myeloma and were refractory to their last treatment. Individuals in the study received either idecabtagene vicleucel or a standard regimen treatment of daratumumab, pomalidomide, and dexamethasone; daratumumab, bortezomib, and dexamethasone; ixazomib, lenalidomide, and dexamethasone; carfilzomib and dexamethasone; or elotuzumab, pomalidomide, and dexamethasone.2
The primary endpoint included progression free survival (PFS), and secondary endpoints included overall response rate and overall survival. At the final PFS analysis, approximately 56% of individuals in the standard regimens arm crossed over to idecabtagene vicleucel as a subsequent therapy.1,2
There was an estimated median follow up of 15.9 months at the primary PFS analysis, according to the press release. Investigators reported that idecabtagene vicleucel resulted in a 51% reduction in the risk of disease progression or death. Furthermore, 71% of patients receiving idecabtagene vicleucel achieved a response with 39% achieving a complete or stringent complete response.1
With the standard regimens, only 42% achieved a response and 5% experienced a complete response. Duration of response with idecabtagene vicleucel was 14.8 months, and for those with a complete response or better, the median duration of response was 20 months.1
Furthermore, investigators reported that idecabtagene vicleucel had a well-established and consistent safety profile, with mostly low-grate cytokine release syndrome and neurotoxicity, according to the press release.1
Trial Name: Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
ClinicalTrials.gov ID: NCT03651128
Sponsor: Celgene
Completion Date (Estimated): April 8, 2027
“The results of the KarMMa-3 study are remarkable, especially given the historic outcomes with standard regimens for these patients with relapsed or refractory disease,” said Al-Ola A. Abdallah, MD, University of Kansas, Clinical Associate Professor, Clinical Director, Hematologic Malignancies and Cellular Therapeutics and chair of US Myeloma Innovations Research Collaborative. “With this approval, these patients now have an opportunity to be treated at an earlier line of therapy with a potentially transformative therapy that offers significantly improved progression-free survival for this difficult-to-treat disease that has had no established treatment approach.”1
Idecabtagene vicleucel has been recently approved in Japan, Switzerland, and the European Union for adults with triple0class exposed relapsed and/or refractory multiple myeloma after 2 lines of prior therapy. Further, it is approved in Great Britain and Israel for adult patients with triple-class exposed relapsed and refractory multiple myeloma after 3 or more prior lines of therapy.1
