Press release
Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients with Heavily Pre-Treated Multiple Myeloma
71% objective response rate, with 46% achieving a complete response or better after 11 months of median follow-up Data to be submitted to regulatory
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"71% objective response rate, with 46% achieving a complete response or better after 11 months of median follow-up Data to be submitted to regulatory authorities, with Biologics License Application on track to be submitted to the FDA this year Regeneron to host virtual investor event to discuss results alongside updates across its hematology portfolio on Thursday, December 14 at 8:30 a.m. ET TARRYTOWN, N.Y., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the primary endpoint analysis from the pivotal trial (LINKER-MM1) investigating linvoseltamab demonstrated high rates of deep and durable responses in patients with relapsed/refractory (R/R) multiple myeloma (MM). These Phase 1/2 results are planned to be submitted to regulatory authorities, including to the U.S. Food and Drug Administration (FDA) this year. Linvoseltamab is an investigational BCMAxCD3 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. “Multiple myeloma remains an incurable disease, in which patients endure cycles of relapse and remission, resulting in a critical need for innovative medicines,” said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Hematology at Regeneron. “With longer follow-up data on linvoseltamab, we’re seeing deep and durable responses with a complete response rate nearing 50% in a difficult-to-treat patient population who had received a median of 5 prior lines of therapy. Furthermore, in our trial, the regimen had a short monitoring time and a convenient, response-adapted administration schedule that enabled deep responders to go from every two-week to every four-week dosing. This regimen saved time for clinicians and patients, underscoring the potential for linvoseltamab as a patient-centric option in relapsed/refractory multiple myeloma.” At a median duration of follow-up of 11 months, an objective response rate of 71% as assessed by an independent review committee, with 46% achieving a complete response or better, was observed in patients treated with linvoseltamab 200 mg in the Phase 1/2 trial (n=117). After a minimum of 24 weeks of therapy, patients who achieved a very good partial response (VGPR) or better sh...