Promising Linvoseltamab Phase 1/2 Results at AACR Showcase Progressive Response in Relapsed/Refractory Multiple Myeloma Patients

Regeneron Pharmaceuticals, a biotech firm listed on NASDAQ as REGN, has reported encouraging results from their Phase 1/2 clinical trial of linvoseltamab, a novel bispecific antibody, for the treatment of patients with multiple myeloma who have relapsed or are refractory to previous treatments. The data was showcased at the AACR Annual Meeting in San Diego, highlighting the drug's potential to significantly improve patient outcomes. 

Linvoseltamab is designed to connect BCMA present on myeloma cells with T-cells expressing CD3, thereby stimulating T-cell activation and the destruction of cancer cells. The treatment has demonstrated a rapid and enduring response rate, with the majority of patients achieving a very good partial response or better after 24 weeks of treatment, allowing them to extend the dosing interval from bi-weekly to monthly. The clinical data, which included a median follow-up of 11 months, showed a 71% objective response rate, with 46% of patients achieving a complete response or better, and 62% reaching a very good partial response or better. The median time to response was one month, and the drug's efficacy was observed across various patient subgroups, including those at high risk or with high tumor burden. 

Despite the positive outcomes, treatment with linvoseltamab was associated with cytokine release syndrome in 46% of patients, with most cases being mild. Infections were also common, affecting 73% of patients, but their frequency and severity decreased after six months of treatment. 

Regeneron has received Fast Track Designation and Priority Review from the FDA for linvoseltamab, with an anticipated decision in August 2024. The company is also conducting a Phase 3 trial (LINKER-MM3) to further validate the drug's effectiveness in treating relapsed/refractory multiple myeloma. 

Multiple myeloma is the second most prevalent blood cancer, with significant global and U.S. incidence rates. Current treatments can slow disease progression but are not curative, and patients often require additional therapies as the cancer advances. Regeneron's ongoing clinical development program for linvoseltamab includes trials in earlier stages of the disease and in combination with other therapies. The company is also exploring treatments for other blood cancers and rare blood disorders, leveraging their VelociSuite® technologies and extensive biology expertise. Regeneron's commitment to innovation in hematology and their broader drug development pipeline reflect their mission to transform lives by developing transformative medicines for serious diseases. The company's forward-looking approach and ongoing research initiatives aim to enhance and expedite the drug development process, offering hope to patients with a range of conditions.

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