Data from a clinical trial demonstrate a “clear clinical benefit” of using a CAR-T cell therapy in patients with multiple myeloma, according to the drugs manufacturer.
Abecma (idecabtagene vicleucel) significantly improved progression-free survival (time during and after treatment when the patient lives without disease progression) compared to standard combination regimens in patients with pretreated relapsed/refractory multiple myeloma, according to Bristol Myers Squibb, the co-manufacturer of the CAR-T cell therapy.
Data from the phase 3 clinical trial, KarMMa-3, also demonstrated an improved overall response rate (a percentage of patients with a partial or complete response to treatment) with Abecma. Safety results were consistent with the already known profile of Abecma, and no new side effects were reported.
“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 Abecma available for earlier lines of treatment for patients and we look forward to discussing these results with regulatory authorities,” said Dr. Steve Bernstein, chief medical officer of 2seventy bio, one of the drugs manufacturers, in a press release.
This is the first randomized clinical trial to evaluate a CAR-T cell therapy in multiple myeloma, according to the release. Patients included had relapsed or refractory disease after two to four prior lines of therapy and refractory to the last regimen.
Full data from the trial will be presented in detail at an upcoming medical meeting.
Abecma was previously approved by the U.S. Food and Drug Administration in March of 2021 for the treatment of patients with multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
“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,” said Anne Kerber, senior vice president, head of Cell Therapy Development at Bristol Myers Squibb.
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