Early, Deep, and Durable Responses with REGN5458, in a First-in-Human Study in Patients with RRMM (https://www.myeloma.org/videos/early-deep-durable-responses-regn5458-first-human-study-patients-rrmm)
Updates on Phase 1/2 Trial REGN5458 Presented at EHA 2022
Dr. Joshua Richter Discusses Phase 1/2 Trial REGN5458 (BCMAxCD3 Bispecific Antibody) for RRMM Patients
Abstract Title:
Early, Deep, and Durable Responses, and Low Rates of CRS with REGN5458, a BCMAXCD3 Bispecific Antibody, in a Phase 1/2 First-in-Human Study in Patients with Relapsed/Refractory Multiple Myeloma
What is the purpose of this trial?
REGN5458 is a BCMAxCD3 bispecific antibody currently under investigation in relapsed/refractory MM (RRMM) in an ongoing Phase 1/2 trial. Preliminary data suggest that REGN5458 has a manageable safety profile with early, deep, and durable responses in heavily pretreated patients.
Phase 1 primary objectives are to assess safety, tolerability and occurrence of dose-limiting toxicities (DLTs) of REGN5458 and to determine a recommended Phase 2 dose regimen (RP2DR) as monotherapy in RRMM patients.
Key secondary objectives include assessment of objective response rate as determined by the investigator, duration of response (DOR) and minimal residual disease (MRD) status; pharmacokinetic evaluation; and characterization of immunogenicity.
Updated safety, overall response and response durability in patients treated with REGN5458 in the Phase 1 portion of this ongoing trial are described here.
In this video:
Dr. Joshua Richter (The Tisch Cancer Institute, Division of Hematology and Medical Oncology, Blavatnik Family-Chelsea Medical Center at Mount Sinai—New York, NY) discusses updates on Phase 1/2 Trial REGN5458 (BCMAxCD3 bispecific antibody) for RRMM patients.
Conclusion:
REGN5458 shows a manageable safety and tolerability profile, with Grade 2 cytokine release syndrome (CRS) in only 4.1% of patients and no Grade ≥3 CRS or neurotoxicity events. No new safety signals were observed during the additional follow-up period. Early, deep, and durable responses were seen in triple- to penta-refractory patients with RRMM, with a 75.0% response rate at the combined 200–800 mg dose levels. The Phase 2 portion of the study is currently recruiting.
Clinical trial information: NCT03761108
Doctor Bio:
Joshua Richter, MD, is Assistant Professor of Medicine in The Tisch Cancer Institute, Division of Hematology and Medical Oncology. He is the director of Multiple Myeloma at the Blavatnik Family-Chelsea Medical Center at Mount Sinai in New York, NY. Dr. Richter treats patients with plasma cell dyscrasias, including multiple myeloma and related diseases such as AL amyloidosis, plasma cell leukemia and Waldenstrom’s Macroglobulinemia. Dr. Richter has extensive experience with clinical trials focused on novel therapies, including antibody therapy and immunotherapy for a precision medicine approach. He has been published in journals such as the New England Journal of Medicine, Blood, and the Journal of Clinical Oncology.
with support from:
Bristol Myers Squibb, Janssen, and Takeda Oncology