Bristol-Myers Squibb, bluebird bio submit biologics license application for advanced multiple myeloma CAR-T
Bristol-Myers Squibb and bluebird bio have submitted a biologics license application to the FDA for idecabtagene vicleucel — an investigational chimeric antigen receptor T-cell therapy — for the treatment of adults with relapsed or refractory multiple myeloma.
The application pertains to use of the therapy by patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Idecabtagene vicleucel (bb2121) is an autologous CAR T-cell therapy that targets the B-cell maturation antigen when it is expressed on the surface of cancer cells.
The companies submitted the application based on topline results of the pivotal phase 2 KarMMa study, which evaluated the efficacy and safety of idecabtagene vicleucel for heavily pretreated patients with relapsed or refractory multiple myeloma.
The study met its primary endpoint of overall response rate and secondary endpoint of complete response rate. The safety profile appeared consistent with that reported in the phase 1 CRB-401 study of idecabtagene vicleucel.
Complete results of the KarMMa study will be presented at a future medical meeting, according to a company-issued press release.
The FDA granted breakthrough therapy designation to idecabtagene vicleucel for the same indication in November 2017, as previously reported by Healio.
Bristol-Myers Squibb and bluebird bio are sponsoring additional ongoing clinical studies of idecabtagene vicleucel for use in earlier lines of treatment in multiple myeloma, including a trial for those with newly diagnosed multiple myeloma.