Bristol-Myers Squibb has received manufacturing and marketing approval in Japan for Abecma (idecabtagene vicleucel) as a third-line therapy for relapsed or refractory multiple myeloma (RRMM).
Abecma is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy. It is now approved for RRMM patients who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
It recognises 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 an interim analysis of data from the Phase III KarMMa-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 versus 4.4 months in the standard regimen arm, demonstrating a 51% lower risk of disease progression or death.
The overall response rate, a key secondary endpoint, was 71.3% in the Abecma arm versus 41.7% in the standard regimen arm.