Regeneron’s Updated Linvoseltamab Data Demonstrates Early, Deep and Durable Responses in Patients with Heavily Pre-treated Multiple Myeloma

Regeneron (NASDAQ:) Pharmaceuticals, Inc. (REGN) today announced updated data from two Phase 2 expansion dose cohorts evaluating investigational linvoseltamab (formerly REGN5458) in patients with heavily pre-treated, relapsed/refractory (R/R) multiple myeloma. The results will be shared in an oral session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the LINKER-MM1 trial will form the basis of planned submissions to regulatory authorities, including to the U.S. Food and Drug Administration (FDA) later 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.

“Despite advances, new treatments are needed that drive meaningful and durable responses to help patients with relapsed and/or refractory multiple myeloma,” said Hans Lee, M.D., Associate Professor and Director, Multiple Myeloma Clinical Research at The University of Texas MD Anderson Cancer Center. “Treatment with linvoseltamab at the recommended 200 mg dose in the LINKER-MM1 trial demonstrated impressive efficacy, with rapid, deep and durable responses in patients with multiple myeloma that’s highly refractory to standard therapies. Moreover, less than half of patients experienced any grade cytokine release syndrome, which was mostly Grade 1, with some Grade 2 and a single Grade 3 case. This reinforces the potential of linvoseltamab as a promising treatment option.”

The new data to be presented at ASCO 2023 are from patients treated in the 50 mg (n=104) and 200 mg (n=117) cohorts of the Phase 1/2 trial. Initial results were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition in December 2022. Among the 200 mg cohort, the median soluble BCMA (sBCMA) was 377 ng/mL, 22% had bone marrow plasma cells ≥50% and 36% had high-risk cytogenetics, representing a patient population with a high disease burden and poor prognosis. The primary endpoint was objective response rate (ORR) assessed by independent review committee, which will be available when the data are more mature. The secondary endpoints included ORR and other efficacy measures assessed by local investigator. With a median follow-up of 6…