Journal article
Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial
Nature medicine, Vol.29(10), pp.2570-2576
10/2023
DOI: 10.1038/s41591-023-02589-w
PMCID: PMC10579053
PMID: 37783970
Abstract
Abstract 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 .
Details
- Title: Subtitle
- Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial
- Creators
- Nizar J. Bahlis - University of CalgaryCaitlin L. Costello - University of California San DiegoNoopur S. Raje - Massachusetts General HospitalMoshe Y. Levy - Baylor Scott & White HealthBhagirathbhai Dholaria - Vanderbilt UniversityMelhem Solh - Northside HospitalMichael H. Tomasson - University of IowaMichael A. Damore - Pfizer (United States)Sibo Jiang - Pfizer (United States)Cynthia Basu - Pfizer (United States)Athanasia Skoura - Pfizer (United States)Edward M. Chan - Pfizer (United States)Suzanne Trudel - Princess Margaret Cancer CentreAndrzej Jakubowiak - University of Chicago Medical CenterCristina Gasparetto - Duke UniversityMichael P. ChuAndrew Dalovisio - Ochsner Health SystemMichael Sebag - McGill University Health CentreAlexander M. Lesokhin - Memorial Sloan Kettering Cancer Center
- Resource Type
- Journal article
- Publication Details
- Nature medicine, Vol.29(10), pp.2570-2576
- DOI
- 10.1038/s41591-023-02589-w
- PMID
- 37783970
- PMCID
- PMC10579053
- NLM abbreviation
- Nat Med
- ISSN
- 1078-8956
- eISSN
- 1546-170X
- Grant note
- DOI: 10.13039/100004319, name: Pfizer, award: Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable, Not applicable
- Language
- English
- Electronic publication date
- 10/02/2023
- Date published
- 10/2023
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Health, Sport, and Human Physiology ; Internal Medicine
- Record Identifier
- 9984473618802771
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