REGN5459 is a bispecific BCMA/CD3 T cell engaging antibody.

SparkCures ID 379
Developed By Regeneron Pharmaceuticals
Generic Name REGN5459
Treatment Classifications
Treatment Targets

Clinical Trials

Published Results

New Bispecific Antibody Demonstrates Clinical Activity in Patients With Multiple Myeloma

April 17, 2023

Patients with relapsed or refractory multiple myeloma who were treated with the two highest doses of REGN5459, a bispecific antibody targeting BCMA and CD3, experienced a 90.5% overall response rate, according to results of a phase I/II clinical trial presented at the AACR Annual Meeting 2023, held April 14-19.

REGN5459 binds to BCMA on malignant plasma B cells that constitute multiple myeloma and CD3 on T cells, bringing the two cell types together so that the latter can attack the former.


The overall response rate in the study population was 65.1%. Among the 21 patients treated at the higher doses (480 mg and 900 mg), the response rate was 90.5%, of which 61.9% were complete responses or better, including 38.1% that were stringent complete responses, a deeper response category characterized by the absence of clonal myeloma cells in the bone marrow and a normal blood test result for free light chains.

Responses occurred early and deepened with time, with a projected 78.1% of patients continuing to respond at a year. “In comparison to the average lifespan of heavily pretreated patients at this stage, which is six to nine months, that the one-year progression-free survival may be more than 70% is very promising,” Suvannasankha said.

In terms of adverse events, across all dose levels, 53.5% of patients experienced CRS, of which none were grade 4 or 5 and 87% were grade 1. In all cases, Suvannasankha said, the condition did not lead to discontinuation and the patients were able to escalate treatment to the full planned dose.


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