CHMP Recommends EU Approval of Linvoseltamab for Relapsed/Refractory Multiple Myeloma

TARRYTOWN, N.Y., Feb. 28, 2025 (GLOBE NEWSWIRE) – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has delivered a positive opinion endorsing the conditional marketing authorization of linvoseltamab. This recommendation is intended for the treatment of adults with relapsed and refractory multiple myeloma (MM) who have already undergone at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, with evidence of disease progression. The European Commission is anticipated to give a final decision in the upcoming months.

The basis for this favorable CHMP opinion stems from data derived from the pivotal LINKER-MM1 trial, which assessed the efficacy of linvoseltamab in adults with relapsed and refractory MM. Earlier this month, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application for linvoseltamab, with a target action date set for July 10, 2025. It is important to note that linvoseltamab is still investigational and has not yet received approval from any regulatory authority.

Multiple myeloma is the second most prevalent blood cancer, with over 35,000 new cases diagnosed annually in Europe and 187,000 globally. Characterized by the abnormal growth of cancerous plasma cells that overcrowd healthy blood cells in the bone marrow, this disease often leads to severe organ damage. Despite advancements in treatments, multiple myeloma remains incurable, and while current therapies can slow cancer progression, most patients eventually experience progression and require further treatment options.

Linvoseltamab is an investigational bispecific antibody that targets BCMA on multiple myeloma cells and CD3 on T-cells to activate T-cell-induced cancer cell destruction. The ongoing LINKER-MM1 trial, a multicenter and open-label study, involved 282 participants with relapsed and refractory MM. The initial Phase 1 part of the trial, which is now complete, primarily focused on assessing safety, tolerability, and dose-limiting toxicities across nine dosage levels. The ongoing Phase 2 part is examining the safety and anti-tumor activity of linvoseltamab, with the main goal being the objective response rate. Secondary goals include response duration, progression-free survival, and overall survival.

Eligibility for the Phase 2 trial requires participants to have received at least three prior treatment regimens or to have triple-class refractory MM. Linvoseltamab is administered starting with a step-up dosing schedule, followed by a full 200 mg weekly dose. After 16 weeks, dosing transitions to every two weeks, and if patients achieve a very good partial response after 24 weeks, they may shift to a four-week dosing schedule. The regimen includes two 24-hour hospital stays for safety monitoring.

Regeneron is exploring linvoseltamab in a comprehensive clinical development program, assessing its potential as both a monotherapy and in combination regimens across various MM treatment lines. This includes further evaluation in the LINKER-MM2 and LINKER-MM3 trials for use in combination treatments and as a standalone therapy, respectively.

Regeneron is a biotechnology leader with a focus on developing innovative treatments for serious diseases, utilizing proprietary technologies like VelociSuite® to advance the development of fully human antibodies. Their research encompasses a wide range of diseases, including cancer, blood disorders, and rare conditions, continually pushing the boundaries of scientific discovery to improve patient outcomes.