Elranatamab, a BCMA Targeted T-Cell Engaging Bispecific Antibody, Induces Durable Clinical and Molecular Responses for Patients with Relapsed or Refractory Multiple Myeloma
Multiple myeloma (MM) is a plasma cell dyscrasia characterized by expression of B-cell maturation antigen (BCMA). Elranatamab (PF-06863135), a bispecific antibody that targets BCMA and CD3 on T-cells, activates and redirects the T-cell mediated immune response against MM. This clinical trial, MagnetisMM-1 (NCT03269136), is the ongoing Phase 1 first-in-human study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of elranatamab for patients (pts) with relapsed or refractory MM.
Elranatamab was administered subcutaneously (SC) at doses from 80 to 1000µg/kg either weekly or every 2 weeks. Treatment-emergent adverse events (TEAEs) were graded by National Cancer Institute Common Terminology Criteria for Adverse Events (v4.03), whereas cytokine release syndrome (CRS) was assessed by criteria of the American Society for Transplantation and Cellular Therapy. PK, cytokines, lymphocyte subsets, and soluble BCMA were analyzed over time. Clinical response was assessed by criteria of the International Myeloma Working Group (IMWG). Minimal residual disease (MRD) was assessed by next generation sequencing at a sensitivity of 1×10-5 in accordance with IMWG criteria.
Elranatamab induced durable clinical and molecular responses for pts with relapsed or refractory MM. The ORR was 64% with more than half of these pts (38%) achieving CR or better, and 100% of evaluable pts achieved MRD negativity. Together with emerging data from pivotal studies MagnetisMM-3 (NCT0469359) and MagnetisMM-5 (NCT05020236), these results support further development of elranatamab for patients with MM.
ASH 2022: Abstract #158
Noopur Raje, MD, Nizar Jacques Bahlis, MD, Caitlin Costello, MD, Bhagirathbhai Dholaria, MBBS, Melhem Solh, MD, Moshe Yair Levy, MD, Michael H Tomasson, MD, Michael A. Damore, PhD, Sibo Jiang, PhD, Cynthia Basu, PhD, Athanasia Skoura, PhD, Edward M Chan, MD, Suzanne Trudel, Andrzej Jakubowiak, MD, PhD, Michael P Chu, MD, Cristina J. Gasparetto, MD, Andrew P. Dalovisio, MD, Michael Sebag, MD, PhD and Alexander M Lesokhin, MD
Doctor Bio:
Dr. Noopur Raje is the Director of the Center for Multiple Myeloma at Massachusetts General Hospital. Her research focuses on understanding the biology of multiple myeloma and development of novel therapeutics for the treatment of myeloma.
