Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial.

Bahlis, Nizar J

Costello, Caitlin L

Raje, Noopur S

Levy, Moshe Y

Dholaria, Bhagirathbhai

Solh, Melhem

Tomasson, Michael H

Damore, Michael A

Jiang, Sibo

Basu, Cynthia

Skoura, Athanasia

Chan, Edward M

Trudel, Suzanne

Jakubowiak, Andrzej

Gasparetto, Cristina

Chu, Michael P

Dalovisio, Andrew

Sebag, Michael

Lesokhin, Alexander M

2024-04-01T16:38:41Z

2024-04-01T16:38:41Z

2023-10

Multiple myeloma (MM) is a plasma cell malignancy expressing B cell maturation antigen (BCMA). Elranatamab, a bispecific antibody, engages BCMA on MM and CD3 on T cells. The MagnetisMM-1 trial evaluated its safety, pharmacokinetics and efficacy. Primary endpoints, including the incidence of dose-limiting toxicities as well as objective response rate (ORR) and duration of response (DOR), were met. Secondary efficacy endpoints included progression-free survival (PFS) and overall survival (OS). Eighty-eight patients with relapsed or refractory MM received elranatamab monotherapy, and 55 patients received elranatamab at efficacious doses. Patients had received a median of five prior regimens; 90.9% were triple-class refractory, 29.1% had high cytogenetic risk and 23.6% received prior BCMA-directed therapy. No dose-limiting toxicities were observed during dose escalation. Adverse events included cytopenias and cytokine release syndrome. Exposure was dose proportional. With a median follow-up of 12.0 months, the ORR was 63.6% and 38.2% of patients achieving complete response or better. For responders, the median DOR was 17.1 months. All 13 patients evaluable for minimal residual disease achieved negativity. Even after prior BCMA-directed therapy, 53.8% achieved response. For all 55 patients, median PFS was 11.8 months, and median OS was 21.2 months. Elranatamab achieved durable responses, manageable safety and promising survival for patients with MM. ClinicalTrials.gov Identifier: NCT03269136 .

10.1038/s41591-023-02589-w

1078-8956

1546-170X

https://hdl.handle.net/10161/30450

eng

Springer Science and Business Media LLC

Nature medicine

10.1038/s41591-023-02589-w

https://creativecommons.org/licenses/by-nc/4.0

T-Lymphocytes

Humans

Multiple Myeloma

Anemia

Immunotherapy, Adoptive

B-Cell Maturation Antigen

Progression-Free Survival

Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial.

Journal article

2570

2576

10

Duke

School of Medicine

Clinical Science Departments

Institutes and Centers

Medicine

Duke Cancer Institute

Medicine, Hematologic Malignancies and Cellular Therapy

Published

29