BMY, 2seventy’s Abecma Demonstrates Positive Results for Treatment of Multiple Myeloma

Bristol Myers Squibb (BMY) and 2seventy Bio Inc announced positive topline results from KarMMa-3 (NCT03651128), a global, open-label, phase 3, randomized study, evaluating idecabtagene vicleucel (Abecma) compared with the standard combination regimens in adults with relapsed and refractory multiple myeloma after 2 to 4 lines of prior therapy and refractory to the last regimen.

The study is the first randomized clinical trial to evaluate a CAR T-cell therapy for multiple myeloma.

“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,” Anne Kerber, PharmD, senior vice president and head of cell therapy development at BMY, said in a statement. “These data reinforce our commitment to unlocking the full potential of cell therapy as we strive to build on the company’s heritage of innovation in blood cancers and transform patients’ lives through science.”

The results of the interim analysis were conducted by an independent review committee and showed that the study met its primary endpoint of demonstrating a statistically significant improvement in progression-free survival.

Additionally, treatment with idecabtagene vicleucel showed an improvement in the key secondary endpoint of overall survival (OS) rates compared with standard regimens and will continue to be evaluated.

Safety results in the trial were consistent with the predictable and well-established safety profile of idecabtagene vicleucel in the KarMMa trial with no new safety signals reported.

The most common nonlaboratory adverse reactions that were reported included decreased appetite, diarrhea, fatigue, infections, musculoskeletal pain, and nausea.

“We are extremely pleased to have met the KarMMa-3 primary endpoint at an interim analysis. These results help to advance our efforts to make [idecabtagene vicleucel] available for earlier lines of treatment for patients and we look forward to discussing these results with regulatory authorities,” Steve Bernstein, MD, chief medical officer at 2seventy bio, said in the statement.

“[The] results are another important proof point for the transformative potential of autologous cell therapy and underscore the importance of continuing to study [idecabtagene vicleucel] in earlier treatment settings for multiple myeloma,” he said.

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

The FDA approved idecabtagene vicleucel in March 2021 for the treatment of individuals with relapsed or refractory multiple myeloma after 4 or more prior lines of therapy, including an anti-CD38 monoclonal antibody, an immunomodulator agent, and a proteasome inhibitor.

Idecabtagene vicleucel is a BCMA-directed, first-in-class CAR T-cell immunotherapy. The drug recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T-cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

Reference

Bristol Myers Squibb and 2seventy bio announce topline results from KarMMa-3 trial showing Abecma (idecabtagene vicleucel) significantly improves progression-free survival versus standard regimens in relapsed and refractory multiple myeloma. News release. August 10, 2022. Accessed August 10, 2022. https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-and-2seventy-bio-Announce-Topline-Results-from-KarMMa-3-Trial-Showing-Abecma-idecabtagene-vicleucel-Significantly-Improves-Progression-Free-Survival-Versus-Standard-Regimens-in-Relapsed-and-Refractory-Multiple-Myeloma/default.aspx