TARRYTOWN, N.Y. — Regeneron Pharmaceuticals, Inc., (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. The target action date for the FDA decision is August 22, 2024. Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
The BLA is supported by data from a Phase 1/2 pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM, which were last shared in December 2023. Earlier this month, the European Medicines Agency accepted for review the Marketing Authorization Application for linvoseltamab in the same indication.
As the second most common blood cancer, it’s estimated 35,000 people will be diagnosed with MM in the U.S. every year. MM is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. MM is not curable despite treatment advances. While current treatments are able to slow the progression of the cancer, most patients will ultimately experience disease progression and require additional therapies.
The linvoseltamab clinical development program includes a Phase 3 confirmatory trial in patients with R/R MM (LINKER-MM3) that is currently enrolling. Additional trials in earlier lines of therapy and stages of disease are planned or underway, including 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. A Phase 1 trial of linvoseltamab in combination with a Regeneron CD38xCD28 costimulatory bispecific in MM is also planned.
Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
About the Phase 1/2 Trial
The ongoing, open-label, multicenter Phase 1/2 dose-escalation and dose-expansion LINKER-MM1 trial is investigating linvoseltamab in 282 enrolled patients with R/R MM. Eligibility in the Phase 2 portion required patients to have received at least three prior lines of therapy or have triple-class refractory MM. Linvoseltamab was administered with an initial step-up dosing regimen followed by the full dose. Additionally, in the Phase 2 portion, a response-adapted regimen enabled patients treated with linvoseltamab 200 mg who achieved a very good partial response or a complete response to shift from every two-week to every four-week dosing after a minimum of 24 weeks of therapy.
The Phase 1 dose-escalation portion of the trial, which is now complete, primarily assessed safety, tolerability and dose-limiting toxicities across nine dose levels of linvoseltamab exploring different administration regimens. The Phase 2 dose expansion portion is assessing the safety and anti-tumor activity of linvoseltamab, with a primary endpoint of objective response rate. Key secondary endpoints include duration of response, progression free survival, rate of minimal residual disease negative status and overall survival.
About Regeneron Pharmaceuticals, Inc.
Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world.
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