Regeneron announces results from Phase 1/2 trial of linvoseltamab

Regeneron Pharmaceuticals announced that the primary endpoint analysis from the pivotal trial investigating linvoseltamab demonstrated high rates of deep and durable responses in patients with relapsed/refractory multiple myeloma. These Phase 1/2 results are planned to be submitted to regulatory authorities, including to the U.S. Food and Drug Administration this year. Linvoseltamab is an investigational BCMAxCD3 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. 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. After a minimum of 24 weeks of therapy, patients who achieved a very good partial response or better shifted from every two-week to every four-week dosing. These results build on an earlier data cut, with 8 months of median follow-up, that will be presented at the 65th American Society of Hematology Annual Meeting and Exposition from December 9 to 12 in San Diego, CA. Based on the latest data cut, all patients treated with 200 mg experienced an adverse event (AE), including 85% who experienced Grade greater than or equal to3 adverse events. The most commonly occurring AE was cytokine release syndrome. Of the CRS cases, the majority were Grade 1, 10% were Grade 2 and there was one case of Grade 3 CRS. Adjudicated immune effector cell-associated neurotoxicity syndrome events occurred in 9 patients; Grade 3 ICANS occurred in 3 patients, and no cases of greater than or equal toGrade 4 cases. All grade infections were observed in 73% of patients; 34% were Grade 3 or 4. Deaths due to treatment-emergent AEs on-treatment or within 30 days post last dose occurred in 14 patients, of which 11 (9%) were due to infections.