Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) recently announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for linvoseltamab, a bispecific antibody currently under investigation. The application is seeking approval for treating adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have progressed after undergoing at least three prior therapies.

Linvoseltamab is specifically designed to target B-cell maturation antigen (BCMA) on multiple myeloma cells, creating a connection with CD3-expressing T cells to activate T-cell response and enhance the elimination of cancer cells. The MAA submission is backed by data from the Phase 1/2 pivotal trial (LINKER-MM1), last reported in December 2023, and a Biologics License Application (BLA) submitted to the FDA in the same month.

Multiple myeloma is globally recognized as the second most common blood cancer, with over 176,000 new cases diagnosed annually. Despite advancements in treatment, multiple myeloma remains incurable, leading to the need for additional therapies due to disease progression in a majority of patients.

The linvoseltamab clinical development program comprises a Phase 3 confirmatory trial (LINKER-MM3) that is currently enrolling participants. Ongoing or planned trials in various lines of therapy and disease stages include a Phase 1/2 trial in the first-line setting, a Phase 2 trial in high-risk smoldering MM, and a Phase 2 trial in monoclonal gammopathy of undetermined significance. Additionally, a Phase 1 trial of linvoseltamab in combination with a CD38xCD28 costimulatory bispecific in MM is in the planning stages.

It is important to note that linvoseltamab is still under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

The Phase 1/2 LINKER-MM1 trial, which is ongoing, enrolled 282 patients with R/R MM. All participants had received at least three prior lines of therapy or were triple refractory. The trial incorporated a response-adapted administration schedule, allowing patients who achieved a very good partial response or a complete response to transition from every two-week to every-four-week dosing after a minimum of 24 weeks of therapy.

The completed Phase 1 intravenous dose-escalation portion of the trial focused on safety, tolerability, and dose-limiting toxicities across nine dose levels of linvoseltamab. The Phase 2 dose expansion portion is currently evaluating the safety and anti-tumor activity of linvoseltamab, with primary objectives including the objective response rate. Key secondary objectives encompass the duration of response, progression-free survival, rate of minimal residual disease negative status, and overall survival.

Regeneron is leveraging over three decades of biology expertise and proprietary VelociSuite® technologies in hematology research. Their focus includes bispecific antibodies being investigated as monotherapies and in various combinations, providing flexibility in developing customized and potentially synergistic cancer treatments. Research and collaborations also extend to potential treatments for rare blood disorders, exploring antibody medicine, gene editing, gene-knockout technologies, and investigational RNA approaches targeting abnormal proteins or blocking disease-causing cellular signaling.

 

Source: globenewswire.com

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