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Regeneron's BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1
TARRYTOWN, N.Y., Dec. 5, 2020 /PRNewswire/ -- 63% response rate in patients treated with the highest reported dose Among all patients responding to treatment,
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y., Dec. 5, 2020 /PRNewswire/ -- \n63% response rate in patients treated with the highest reported dose\nAmong all patients responding to treatment, 95% experienced a very good partial response or better; among responding patients with ≥6 months of follow-up, 83% have ongoing responses for up to 13 months at the time of analysis \nPotentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients \nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. The results were shared in an oral presentation at the virtual 2020 American Society of Hematology (ASH) Annual Meeting. BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells. REGN5458 is designed to bind to BCMA on multiple myeloma cells and the CD3 receptor on T-cells in order to bridge them together and activate T-cells to kill the cancer cells.\n\"REGN5458 continues to show early, deep and durable anti-tumor responses in patients with relapsed and refractory multiple myeloma across all dose levels. This is particularly encouraging given that a majority of patients were heavily pretreated and had few options remaining. All patients were triple-refractory, with 57% being penta-refractory,\" said Deepu Madduri, M.D., Assistant Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York and a trial investigator. \"As these data continue to mature, we look forward to assessing whether responses will further deepen and remain durable with ongoing REGN5458 treatment.\"\nIn the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 months (range: 1-13), responses generally occurred by week 4 and deepened over time. Exploratory analyses suggest that patient-reported global health status/quality of life (per EORTC QLQ-C30) also improved meaningfully at week 4 and was maintained through week 24, with assessment ongoing.\nEfficacy results, a secondary endpoint, by dose level were as follows:\n% (n)\nDose Levels 1, 2, ...