Bristol Myers Squibb (BMS) has announced that the European Medicines Agency’s human medicines committee has recommended Abecma (idecabtagene vicleucel) to treat relapsed or refractory multiple myeloma.
The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that the CAR T-cell therapy be authorised for use in adult patients who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
More than 50,000 cases of multiple myeloma, a currently incurable blood cancer arising from plasma cells, are diagnosed each year in Europe. While the course of the disease varies, relapses are almost inevitable, and most patients will receive four or more lines of therapy due to relapse.
If approved by the EC, Abecma would become the first CAR T-cell therapy available in the EU for patients with triple-class exposed relapsed and refractory multiple myeloma earlier in the treatment journey.
The CHMP’s decision was supported by positive results from the late-stage KarMMa-3 study, which compared Abecma with standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy.
At a median follow-up of 30.9 months, Abecma was shown to significantly improved progression-free survival (PFS) compared with standard regimens, with a median PFS of 13.8 months versus 4.4 months.
Results for the key secondary endpoint of overall response rate showed the majority of patients treated with Abecma achieved a response, with 44% achieving a complete response or stringent complete response. In contrast, less than half of those who received standard regimens achieved a response, with 5% experiencing a complete response or stringent complete response.
Anne Kerber, senior vice president and head, late clinical development, haematology, oncology, cell therapy at BMS, said: “This positive CHMP opinion represents an important step toward bringing our potentially transformative first-in-class anti-BCMA CAR T-cell therapy, Abecma, to more patients earlier in the multiple myeloma treatment paradigm to improve outcomes.
“We look forward to working with the EC with the shared goal of delivering innovative treatment options to more patients with continued unmet need.”
Abecma is being jointly developed and commercialised in the US by BMS and 2seventy bio, a spin-out of bluebird bio. BMS assumes sole responsibility for Abecma drug product manufacturing and commercialisation outside of the US.