Regeneron Pharmaceuticals announced the oral plenary session presentation of positive pivotal data from the Phase 1/2 LINKER-MM1 trial of linvoseltamab in patients with relapsed/refractory multiple myeloma at the American Association for Cancer Research Annual Meeting 2024 in San Diego. Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing. The company says that with an 11-month median duration of follow up, the linvoseltamab data among 117 patients presented at AACR reinforce the strength of previously shared findings and included a: 71% objective response rate, with 46% of patients achieving a complete response or better and 62% achieving a very good partial response or better, as determined by an independent review committee; 1-month median time to response; In responders, the median time to a VGPR or better was 3 months and to a CR or better was 8 months; Median duration of response, median progression-free survival and median overall survival were not reached; At 12 months, the estimated probability of maintaining a response was 78%, being progression free was 69% and survival was 75%; Among patients who had a CR or better and were minimum residual disease evaluable, 93% were MRD negative at 10-5. The trial included a response-adapted regimen that enabled linvoseltamab patients to shift to every four-week dosing if they achieved a VGPR or better and completed at least 24 weeks of therapy. In the dose expansion portion of the trial, of the patients who had at least 24 weeks of therapy at data cutoff, 90% achieved a VGPR or better and were able to transition to every four-week dosing. Of the 29 patients who transitioned to the extended dosing regimen prior to achieving a CR, 48% subsequently experienced a deepening of response to CR or better. The Phase 3 confirmatory trial for linvoseltamab in patients with R/R MM is underway.
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