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As presented at ASH, recommended 200 mg dose of linvoseltamab demonstrated a 64% response rate, with 45% of responders achieving a very good partial response or better; responses may further improve with longer follow-up
Trial enrolled patients with particularly high disease burden, with 37% having bone marrow plasma cells ≥50% and the median soluble BCMA being 0.43 mg/L
Data represent initial efficacy results from first 58 patients in ongoing Phase 2 trial, which is now fully enrolled at the recommended dose
TARRYTOWN, N.Y., Dec. 12, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive initial data from a pivotal Phase 2 expansion cohort evaluating investigational linvoseltamab (formerly REGN5458) at the 200 mg dose recommended for further development in patients with heavily pre-treated, relapsed/refractory (R/R) multiple myeloma. The results were part of a broader presentation of new and updated data from a Phase 1/2 trial and were shared at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, LA. Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
"The need for innovative medicines is critical for patients with multiple myeloma who inevitably face a downward spiral of relapses, reduced responses to subsequent therapies, and increasingly shorter remissions," said Naresh Bumma, M.D., Hematologist and Assistant Professor in the Division of Hematology at Ohio State University, and a trial investigator. "At the recommended 200 mg dose in a pivotal Phase 2 trial, linvoseltamab demonstrated early, deep and durable responses in patients living with multiple myeloma who had been on at least three prior therapies, including those with higher risk and high disease burden. These clinically meaningful outcomes at 12 weeks reinforce the positive linvoseltamab results seen in the Phase 1 dose escalation portion, and we look forward to seeing data from more patients and longer follow-up."
As presented at ASH, out of 252 patients treated in the Phase 1/2 trial, 81% of patients were triple-refractory to existing therapeutic options, including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody. Additionally, 37% had bone marrow plasma cells ≥50%, and the median soluble BCMA was 0.43 mg/L, representing a patient population with a higher disease burden than those enrolled in similar trials. Of the 87 patients in the 200 mg cohort, 58 were evaluated for efficacy. With a median follow-up of 3 months (range: 0 to 30 months), efficacy results were as follows:
