BMS’ CAR T therapy Abecma moves closer toward EU approval

Bristol Myers Squibb’s (BMS) CAR T cell therapy Abecma has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending its approval for the treatment of relapsed and refractory multiple myeloma.

Abecma (idecabtagene vicleucel; ide-cel) is a B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy, designed to treat relapsed and refractory multiple myeloma patients who have received at least three prior therapies.

That includes prior treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

The positive CHMP opinion is based on results from the Phase II KarMMa study, which evaluated Abecma in 128 patients with heavily pre-treated and highly refractory multiple myeloma.

In the Phase II KarMMa trial, the overall response rate (ORR) for the efficacy evaluable population was 72% in multiple myeloma patients receiving the CAR-T therapy, with 28% of patients achieving a stringent complete response (sCR).

In addition, a median time to response of 30 days was observed, as well as a median duration of response of 11 months for all responders and 19 months for those who achieved sCR.

Of the patients who achieved sCR, an estimated 65% had remission lasting at least 12 months.

“As the first CAR T cell therapy for relapsed and refractory multiple myeloma to receive a positive CHMP opinion, Abecma represents a potential new treatment approach for patients in Europe battling this incurable blood cancer,” said Noah Berkowitz, senior vice president, cellular therapy development, BMS.

“We look forward to the European Commission’s decision as we build on our innovative multiple myeloma and cell therapy research to offer novel and personalised treatment options for patients in need,” he added.