REGN5459, designed to deplete plasma cells while mitigating the cytokine release syndrome, demonstrated deep and durable clinical responses in heavily pretreated relapsed/refractory myeloma. AACR23
, use of a novel bi-specific antibody designed to minimize the cytokine release syndrome was associated with deep and durable clinical responses, and the safety profile was an acceptable.
Multiple myeloma remains incurable; patients eventually succumb to disease following relapse, Suvannasankha explained. Last year, another bispecific antibody therapy targeting BCMA and CD3, teclistimab , was approved by the US Food and Drug Administration to treat multiple myeloma after four or more lines of therapy, but CRS remains a common and potentially fatal side effect of immunotherapy.
In the current trial, 43 patients with relapsed or refractory multiple myeloma who had received three or more prior lines of therapy were enrolled in the phase 1 dose-finding portion of the trial. The patients were followed in the phase 2 dose-expansion, safety, and efficacy portion. At a median follow-up of 9 months, the objective response rate in the overall population was 65.1%. Among 21 of the 43 patients who received doses ranging from 480 to 900 mg, the ORR was 90.5%, which included complete remissions or stringent complete remissions in 69.1% of this group.
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