The approval was based on the interim analysis of 386 patients in the Phase 3 KarMMa-3 study in which mPFS was 13.3 months in the Abecma arm in comparison to 4.4 months in the standard regimen arm
Bristol-Myers Squibb K.K. has obtained manufacturing and marketing approval of the supplemental New Drug Application for an additional indication for Abecma (idecabtagene vicleucel) to treat certain multiple myeloma patients in Japan.
Abecma is a chimeric antigen receptor (CAR) T-cell immunotherapy directed at the B-cell maturation antigen (BCMA).
The latest approval is intended for patients with relapsed or refractory multiple myeloma (RRMM) who previously received a minimum of two therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
The approval was based on the interim analysis of 386 patients in the Phase 3 KarMMa-3 study of Abecma in RRMM patients.
The trial assessed the safety and efficacy of CAR T-cell immunotherapy against standard treatments, with median progression-free survival (mPFS) as its primary endpoint.
According to the results, mPFS was 13.3 months in the Abecma arm in comparison to 4.4 months in the standard regimen arm.
The findings showed a statistically significant and clinically meaningful growth in mPFS and a 51% reduced risk of disease progression or casualty risk in the Abecma arm compared to the standard regimen.
The overall response rate (ORR), which was the key secondary endpoint, was observed at 71.3% in the Abecma arm against 41.7% in the standard regimen arm.
KarMMa-3 recorded no new safety concerns in the trial subjects.
Bristol Myers Squibb Japan research and development head Makoto Sugita said: “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.”
In a separate development, BMS expanded its partnership with IMIDomics to accelerate research and development in immune-mediated inflammatory diseases (IMIDs) treatment.
Under the collaboration, both firms will collect clinical and epidemiological data from patients with Sjögren’s disease and atopic dermatitis to generate advanced biomolecular data.