NEW YORK – Bristol Myers Squibb and 2seventy bio on Wednesday said they will speak with regulators about positive interim data on Abecma (idecabtagene vicleucel) from the Phase III KarMMa-3 trial and advancing the CAR T-cell therapy as an earlier-line therapy for relapsed or refractory multiple myeloma patients. The autologous, BCMA-directed cell therapy is already approved for multiple myeloma patients after four or more prior lines of therapy based on the results of the single-arm Phase II KarMMa trial.
Now, the new interim data from the KarMMa-3 trial — the first randomized trial to evaluate a CAR T-cell therapy for multiple myeloma patients — show that patients receiving Abecma experienced longer progression-free survival than those receiving one of five standard-of-care combination regimens. BMS and 2seventy also said the interim analysis showed that patients experienced improvements in key secondary endpoints, including overall response rates.
BMS and 2seventy are jointly developing the autologous CAR T-cell therapy. Overall survival analysis is still ongoing in the trial.
Patients enrolled in the trial had to have between two and four previous therapies, an eligibility window that includes earlier-line patients than those who can already receive Abecma as a fifth-line treatment. Although BMS and 2seventy have not reported on the breakdown of results by treatment line in the KarMMa-3 trial, Anne Kerber, senior VP and head of cell therapy development at BMS, said in a statement that the results "clearly demonstrate the clinical benefit of using a CAR T-cell therapy earlier in the multiple myeloma treatment paradigm."
In addition to speaking with regulators, BMS and 2seventy plan to present detailed results from the KarMMa-3 trial at an upcoming medical meeting.