BMS and 2seventy bio announce positive results for multiple myeloma treatment

Bristol Myers Squibb (BMS) and 2seventy bio – a spin-out of bluebird bio – have announced positive phase 3 trial top-line results for Abecma (idecabtagene vicleucel) as a treatment for relapsed and refractory multiple myeloma.

The phase 2 KarMMa-3 study is a global, randomised, open-label study of Abecma compared to standard combination regimens in adults with multiple myeloma that is relapsed and refractory after two to four prior lines of therapy, and refractory to the last regimen.

Commenting on the positive results, Anne Kerber, senior vice president and head of Cell Therapy Development, BMS, said: “Results from the KarMMa-3 study clearly demonstrate the clinical benefit of using a CAR T-cell therapy earlier in the multiple myeloma treatment paradigm. This data reinforces our commitment to unlocking the full potential of cell therapy.”

The study met its primary endpoint of demonstrating a statistically significant improvement in progression-free survival. Treatment with Abecma also showed an improvement in the key secondary endpoint of overall response rate compared to standard regimens.

Follow-up for overall survival, a key secondary endpoint, remains ongoing. The safety profile for Abecma was consistent with previous studies and no new safety signals were reported.

Steve Bernstein, chief medical officer, 2seventy bio, said: “The results help to advance our efforts to make Abecma available for earlier lines of treatment for patients.

“Today’s results are another important proof point for the transformative potential of autologous cell therapy and underscore the importance of continuing to study Abecma in earlier treatment settings for multiple myeloma.”

Multiple myeloma is an incurable blood cancer that impacts plasma cells – a type of white blood cell – which are found in the bone marrow.

Abecma was approved by the US Food and Drug Administration (FDA) in March 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

The companies will complete a full evaluation of the KarMMa-3 data and present results at an upcoming medical meeting and discuss these results with health authorities.