Biotechnology company Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced on Friday that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for linvoseltamab, aimed at treating adult patients with relapsed/refractory (R/R) multiple myeloma (MM) after three prior therapies.

Linvoseltamab is an investigational bispecific antibody targeting B-cell maturation antigen (BCMA) on MM cells to activate T-cells and eliminate cancer cells. The MAA review is based on data from the Phase 1/2 trial (LINKER-MM1), last reported in December 2023, and a Biologics License Application (BLA) submitted to the FDA in December 2023.

With over 176,000 new MM cases annually globally, the disease is the second most common blood cancer, characterized by MM cell proliferation leading to organ damage. Despite treatment advances, MM remains incurable, necessitating additional therapies post-progression.

The linvoseltamab clinical program involves a Phase 3 confirmatory trial (LINKER-MM3) and other trials across different disease stages and lines of therapy, including a Phase 1/2 trial in the first-line setting and Phase 2 trials in high-risk smoldering MM and monoclonal gammopathy of undetermined significance. Further trials are planned, including a Phase 1 trial of linvoseltamab in combination with a CD38xCD28 bispecific. Clinical development of linvoseltamab is ongoing, with safety and efficacy yet to be fully assessed by regulatory authorities.

The Phase 1/2 LINKER-MM1 trial, enrolling 282 R/R MM patients, explores linvoseltamab's safety and anti-tumor activity, with a response-adapted administration schedule. The trial's Phase 1 dose-escalation portion focused on safety and dose-limiting toxicities, while the Phase 2 dose expansion evaluates anti-tumor activity, emphasizing objective response rate and key secondary endpoints.