CAR-T Abecma Multiple Myeloma Treatment Increases PFS by More Than Three Times, and CAR-T Cell Therapy Targeting BCMA has been re Approved by the FDA
CAR-T Abecma Multiple Myeloma Treatment Increases PFS by More Than Three Times, and CAR-T Cell Therapy Targeting BCMA has been re Approved by the FDA
Bristol Myers Squibb and 2seventy bio recently announced that the U.S. FDA has approved Abecma (idecabtagene vicleucel), a CAR-T cell therapy targeting B-cell maturation antigen (BCMA), for the treatment of adult patients with relapsed or refractory multiple myeloma after receiving at least two prior therapies, including an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody, based on the results of the KarMMa-3 clinical trial. This approval expands the indication for Abecma, allowing it to treat earlier-stage multiple myeloma patients.
This approval was based on the positive results of the Phase 3 KarMMa-3 clinical trial. In this study, 254 patients were randomly assigned to receive Abecma, while 132 patients were randomly assigned to receive different types of standard treatment regimens based on their most recent treatment and the investigator’s judgment.
At a median follow-up of 15.9 months, compared to the standard regimen, Abecma more than tripled the median progression-free survival (PFS), the primary endpoint, reaching 13.3 months (95% CI: 11.8-16.1) versus 4.4 months (95% CI: 3.4-5.9) in the active control group, with a statistically significant difference (HR: 0.49; 95% CI: 0.38-0.64; p<0.0001). This indicates that the use of Abecma reduced the risk of disease progression or death by 51%.
Abecma also demonstrated a significant improvement in the overall response rate (p<0.0001), with the majority (71%) of patients receiving Abecma achieving a response, and 39% achieving a complete response or stringent complete response. In contrast, less than half (42%) of patients receiving the standard regimen achieved a response, and 5% experienced a complete response or stringent complete response. The median duration of response for Abecma treatment was 14.8 months (95% CI: 12.0-18.6).
Abecma is a CAR-T cell therapy that can recognize and bind to BCMA on the surface of multiple myeloma cells, leading to CAR-T cell proliferation, cytokine secretion, and subsequent killing of BCMA-expressing cells.