Abecma May Be Effective Early Therapy for Hard-to-treat Myeloma
Treatment led to an improvement in overall response rate in KarMMa-3 trial
Note: This story was updated Sept. 26, 2022, to correct the fact that Abecma is approved for patients in Europe and Japan who have undergone at least three prior therapies, not four as originally stated.
The CAR T-cell therapy Abecma (idecabtagene vicleucel) significantly extended survival without signs of disease worsening in adults with relapsed or refractory multiple myeloma who received two to four prior therapies and failed to respond to the last regimen, top-line trial results show.
The KarMMa-3 Phase 3 clinical trial, which has met its primary goal, also showed that the treatment safely led to an improvement in the overall response rate — a key secondary goal that assessed the proportion of patients who achieved a partial or complete response to the therapy — compared to standard regimens.
The findings, from a pre-specified interim analysis conducted by an independent review committee, support the efficacy of Abecma as an early treatment for multiple myeloma, according to Bristol Myers Squibb and 2seventy bio, the therapy’s developers in the U.S.
Abecma is approved in Europe and Japan for myeloma patients who have received at least three prior therapies, including one immunomodulatory drug, one proteasome inhibitor, and one CD38 inhibitor. In the U.S., it’s approved for patients who have undergone at least four prior therapies.
What did the KarMMa-3 Phase 3 trial find?
“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, MD, senior vice president, head of Cell Therapy Development at Bristol Myers Squibb, said in a press release.
“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,” Kerber added.
Follow-up analysis of overall survival, a key secondary endpoint, remains underway. No new safety signs were reported. The companies will conduct a full analysis of the data, which will be presented at upcoming medical meetings and discussed with health authorities.
“We are extremely pleased to have met the KarMMa-3 primary endpoint at an interim analysis,” said Steve Bernstein, MD, chief medical officer at 2seventy bio. “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.”
CAR T-cell therapy is a type of immunotherapy in which researchers collect a patient’s own (autologous) T-cells — immune cells with anti-cancer activity — and engineer them in the lab to recognize and eliminate cancer cells. This is done by introducing a gene in the cells’ genome that codes for a man-made receptor — called a chimeric antigen receptor, or CAR — which recognizes and targets a specific cancer molecule.
Abecma recognizes the BCMA protein that is found at particularly high levels on the surface of myeloma cells. The engineered cells are then expanded and infused back into the patient. By targeting BCMA only, the modified T-cells are expected to trigger the death of myeloma cells, while leaving healthy cells largely unharmed.
KarMMa-3 (NCT03651128) is an international, open-label trial evaluating Abecma’s safety and effectiveness versus standard regimens in relapsed and refractory myeloma patients who received two to four prior treatment regimens and failed to respond to their last one.
“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,” said Bernstein.