Linvoseltamab Receives EMA Filing Acceptance for Treatment of Relapsed/Refractory Multiple Myeloma
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The acceptance of the Marketing Authorization Application for linvoseltamab by the European Medicines Agency marks a significant milestone for Regeneron Pharmaceuticals in the treatment of multiple myeloma (MM). This is particularly notable given the high unmet medical need in the relapsed/refractory (R/R) MM patient population, which has been through multiple lines of therapy with limited options remaining.
Linvoseltamab, as a bispecific antibody, represents a novel therapeutic approach by binding to both BCMA on MM cells and CD3 on T cells, potentially offering a new mechanism of action compared to existing treatments. The data from the Phase 1/2 LINKER-MM1 trial, which underpins the MAA, will be critical in determining the efficacy and safety profile of the drug. If approved, linvoseltamab could become a key player in a market that is rapidly evolving with the introduction of new therapies like CAR-T treatments and monoclonal antibodies.
From a clinical perspective, the progression to a Phase 3 trial (LINKER-MM3) for linvoseltamab indicates promising results from earlier phases. For patients with R/R MM, the therapeutic landscape has expanded with treatments aiming to improve survival rates and quality of life. However, MM remains incurable and the disease's refractory nature often leaves patients with few options after first-line treatments fail.
The ongoing research into linvoseltamab's use in earlier stages of MM and in combination therapies is a testament to the industry's push for comprehensive treatment regimens. The drug's bispecific nature may enhance T-cell mediated cytotoxicity, potentially offering a more robust response against MM cells. If the clinical trials yield positive results, linvoseltamab could significantly impact treatment protocols and patient outcomes in MM.
For investors, the EMA's review of linvoseltamab's MAA could signal a potential future revenue stream for Regeneron, contingent on approval and successful commercialization. The global MM market is expected to grow, driven by an increase in the disease's prevalence and the introduction of new therapies. Regeneron's entry into this space with a novel bispecific antibody could capture a significant market share, especially given the over 176,000 new cases of MM diagnosed annually worldwide.
Investors should monitor the outcomes of the regulatory review process and subsequent market introduction, as well as the progression of the Phase 3 trial. The investment community typically responds positively to advancements in late-stage clinical trials, especially in areas with high unmet needs. However, they should also consider the competitive landscape and potential pricing pressures in the oncology market.
TARRYTOWN, N.Y., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have progressed after at least three prior therapies. Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
The MAA 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. A Biologics License Application (BLA) was also submitted to the FDA in December 2023.
As the second most common blood cancer, there are over 176,000 new cases of MM diagnosed globally every year. It 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 (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 CD38xCD28 costimulatory bispecific in MM is also planned. For more information, contact clinicaltrials@regeneron.com or 844-734-6643, or visit the Regeneron clinical trials website.
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 patients with R/R MM. Among 282 patients enrolled, all received at least three prior lines of therapy or were triple refractory. Linvoseltamab was administered with an initial step-up dosing regimen followed by the full dose. Additionally, a response-adapted administration schedule enabled patients 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 intravenous 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 objective of objective response rate. Key secondary objectives include duration of response, progression free survival, rate of minimal residual disease negative status and overall survival.
About Regeneron in Hematology
At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite® technologies to develop medicines for patients with diverse blood cancers and rare blood disorders.
Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments.
Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling.
About Regeneron
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.
For more information about Regeneron, please visit www.Regeneron.com or follow Regeneron on LinkedIn.
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FAQ
What is the Marketing Authorization Application (MAA) for linvoseltamab by the European Medicines Agency?
What is linvoseltamab?
What data supports the MAA for linvoseltamab?
What additional trials are planned or underway for linvoseltamab?
What is multiple myeloma (MM)?
