Updated Linvoseltamab Data Showcase Continued Deepening of Responses in Patients with Heavily Pre-Treated Multiple Myeloma

Core Insights - Regeneron Pharmaceuticals announced promising results from the 14-month median follow-up of the Phase 1/2 LINKER-MM1 trial for linvoseltamab in relapsed/refractory multiple myeloma, showing a 71% overall response rate and 50% of patients achieving a complete response or better [1][2][4] Clinical Trial Results - The LINKER-MM1 trial demonstrated a 71% objective response rate (ORR) with 50% of patients achieving a complete response (CR) or better, and 63% achieving a very good partial response (VGPR) or better [2][4] - Median duration of response (DoR) was 29 months for all responders, with an 81% and 95% estimated probability of maintaining a response at 12 months for all patients and those achieving a CR or better, respectively [2][3] - Median progression-free survival (PFS) was not reached, with a 70% estimated probability of being progression-free at 12 months among all patients [2][4] - Median overall survival (OS) was 31 months for all patients, with a 75% and 100% estimated probability of survival at 12 months among all patients and those achieving a CR or better, respectively [2][4] Safety Profile - Safety data indicated that cytokine release syndrome (CRS) was the most common treatment-emergent adverse event (TEAE), occurring in 46% of patients, with 35% being Grade 1 and 10% Grade 2 [3] - Infections were reported in 74% of patients, with 36% classified as Grade 3 or 4, but decreased in frequency and severity after 6 months [3] Comparative Study - A retrospective study comparing linvoseltamab to real-world standard-of-care treatment showed an ORR of 70% for linvoseltamab versus 32% for standard treatment, with median PFS of 20 months versus 3 months [4] - The study also indicated that the median OS for linvoseltamab was not reached compared to 12 months for standard treatment [4] Regulatory Status - Linvoseltamab has received Fast Track Designation and is under Priority Review by the U.S. FDA for the treatment of relapsed/refractory multiple myeloma, with a target action date of August 22, 2024 [4][5] Ongoing Development - The Phase 3 confirmatory trial (LINKER-MM3) for linvoseltamab in patients with relapsed/refractory multiple myeloma is currently ongoing [5] - The broader clinical development program includes additional trials in earlier lines of therapy and stages of disease [9]