▎Edited by the WuXi AppTec content team

Recently, Regeneron announced,The European Medicines Agency (EMA) has accepted the company's Marketing Authorization Application (MAA) for linvoseltamab, a bispecific antibody therapy targeting B-cell maturation antigen (BCMA), for the treatment of patients with relapsed/refractory multiple myeloma.。Their disease progressed after receiving at least three prior treatments.The press release also pointed out that the company had completed the submission of a Biologics License Application (BLA) to the U.S. FDA in December last year.

The submission of this application is based on the results of the pivotal Phase 1/2 clinical trial, LINKER-MM1. The trial results, published last December, showed that at a median follow-up time of 11 months, in the Phase 1/2 clinical trial (n=117),Patients treated with linvoseltamab at a dose of 200 mg showed an objective response rate of 71%, with 46% achieving complete response or better.

As of the latest data cutoff date, all patients receiving the 200 mg treatment experienced adverse events (AEs), with 85% of patients experiencing Grade ≥3 adverse events (AEs). The most common AE was cytokine release syndrome (CRS; 46%). Among CRS cases, the majority (35%) were Grade 1, 10% were Grade 2, and one case (1%) was Grade 3 CRS.

Karen Rodriguez-Lorenc, M.D., global program leader of Regeneron's linvoseltamab, previously told industry media Fierce Biotech that among comparable drugs, the incidence of CRS with linvoseltamab falls within the "lower range." Since linvoseltamab is administered intravenously, CRS cases occur earlier during treatment, allowing for easier monitoring and care. Additionally, the drug’s response rate is within the "higher range" among similar drugs.Linvoseltamab is a potential “best-in-class” bispecific antibody targeting BCMA and CD3.。

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