REGN5458, a BCMA Bispecific Monoclonal Antibody Targeting CD3, in a Phase 1/2 1st-in-Human Study in Relapsed/Refractory Multiple Myeloma Patients (https://www.myeloma.org/videos/regn5458-bcmaxcd3-bispecific-monoclonal-antibody-phase-12-1st-human-study-rrmm-pts)

Dr. Jeffrey Zonder talks about the early, deep, and durable responses with REGN5458

In this video, Dr. Jeffrey Zonder talks about the early, deep, and durable responses, and low rates of cytokine release syndrome (CRS) with REGN5458.

What is REGN5458?

REGN5458 is a BCMA Bispecific Monoclonal Antibody targeting CD3, in a phase 1/2 first-in-human study in patients with relapsed/refractory multiple myeloma (RRMM).

What is the purpose of the study?

To present preliminary data from an ongoing phase 1/2 trial (NCT03761108) demonstrating that REGN5458 (a BCMAxCD3 bispecific antibody) monotherapy had an acceptable safety and tolerability profile with early, deep, and durable responses in heavily pretreated patients (pts), with at least triple-refractory RRMM.

Conclusion:

In this updated analysis of the first-in-human study, REGN5458 continues to show an acceptable safety and tolerability profile, with Gr 2 CRS in only 4.4% of patients, and no Gr ≥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% response rate at the combined 96 and 200 mg dose levels. The phase 2 portion of the study is currently recruiting.

Results from REGN5458

ASH 2021: Abstract 160 (https://ash.confex.com/ash/2021/webprogram/Paper144921.html)

 

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ASH 2021
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Source URL: https://www.myeloma.org/videos/regn5458-bcmaxcd3-bispecific-monoclonal-antibody-phase-12-1st-human-study-rrmm-pts