On the eve of the American Society of Hematology annual meeting, Regeneron Pharmaceuticals, Inc. released data on its multiple myeloma drug candidate linvoseltamab that should support its submission to the US Food and Drug Administration this year. Linvoseltamab isn’t getting top billing among Regeneron’s presentations at ASH, but the Tarrytown, NY-based company will present additional data that will support the drug’s profile in a competitive class.
Regeneron released 7 December an analysis of the pivotal Phase I/II LINKER-MM1 trial that showed a 71% objective response rate (ORR) among 117 patients receiving linvoseltamab at 200mg, while 46% of patients achieved a complete response (CR) or better, after a median duration of follow-up of 11 months. The company is presenting results from an earlier data cut, with eight months of follow-up, in a poster at ASH, along additional poster presentations
Key Takeaways
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Regeneron announced a new analysis from its pivotal study of linvoseltamab, showing deepening responses among heavily pretreated myeloma patients.
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The company is planning additional poster presentations on linvoseltamab at the upcoming ASH conference in San Diego and planning to submit the drug to the FDA by year end
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