Bristol-Myers Squibb K.K. announced that the company has received manufacturing and marketing approval of the supplemental New Drug Application for an additional indication for Abecma (idecabtagene vicleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for patients with relapsed or refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
Abecma is the first-in-class BCMA-directed CAR T cell immunotherapy. Abecma recognizes and binds to BCMA on the surface of multiple myeloma cells, which leads to the proliferation of CAR T cells and cytokine release, resulting in the dissolution and death of BCMA-expressing cells.
Commenting on the approval, Makoto Sugita, Bristol Myers Squibb’s head of R&D in Japan, said, “Multiple myeloma is an intractable disease with recurrent relapses that are difficult to cure with existing therapies. Treatment options for patients with RRMM are limited, and we are pleased that Abecma is the first CAR T cell therapy to be approved for earlier use as a treatment option to address the unmet needs of these patients. We remain committed to researching and developing innovative therapies to transform patient lives with serious diseases through science.”
The approval is based on the interim analysis from KarMMa-3 (BB2121-MM-003), a global Phase 3 study that evaluated the efficacy and safety of Abecma in patients with RRMM who had received two to four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti CD38 monoclonal antibody daratumumab. The median progression-free survival (mPFS), the primary endpoint, was 13.3 months in the Abecma arm vs 4.4 months in the standard regimen arm, demonstrating a statistically significant and clinically meaningful increase in mPFS and a 51% lower risk of disease progression or death in the Abecma arm compared with the standard regimen arm [HR = 0.493 (95.0% CI: 0.377-0.645), p < 0.0001 (log-rank test with stratified factors)]. The overall response rate (ORR), a key secondary endpoint, was 71.3% in the Abecma arm vs 41.7% in the standard regimen arm, and a prespecified stratified test showed a statistically significant improvement for the Abecma arm compared with the standard regimen arm [odds ratio = 3.54 (95.0% CI: 2.26 to 5.54), p < 0.0001 (by a two-sided Cochran-Mantel-Haenszel test)]. The study found no new safety signals for Abecma in patients with RRMM previously treated with two to four therapies including an immunomodulatory agent, a proteasome inhibitor, and daratumumab.
Results from the Phase 3 KarMMa-3 study including final PFS analysis and interim overall survival analysis will be presented during the 65th American Society of Hematology Annual Meeting and Exposition in San Diego, California, December 9 – 12, 2023.