학술논문
Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial.
Document Type
Academic Journal
Author
Bahlis NJ; Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, AB, Canada. nbahlis@ucalgary.ca.; Costello CL; Moores Cancer Center, University of California, San Diego, La Jolla, CA, USA.; Raje NS; Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.; Levy MY; Department of Medical Oncology, Baylor Scott and White Health, Dallas, TX, USA.; Dholaria B; Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.; Solh M; Blood and Marrow Transplant Group of Georgia, Northside Hospital, Atlanta, GA, USA.; Tomasson MH; Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA.; Damore MA; Oncology Research and Development, Pfizer Inc., San Diego, CA, USA.; Jiang S; Early Clinical Development, Pfizer Inc., San Diego, CA, USA.; Basu C; Early Clinical Development, Pfizer Inc., San Diego, CA, USA.; Skoura A; Early Clinical Development, Pfizer Inc., Collegeville, PA, USA.; Chan EM; Oncology Research and Development, Pfizer Inc., South San Francisco, CA, USA.; Trudel S; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.; Jakubowiak A; Department of Medicine, University of Chicago Medical Center, Chicago, IL, USA.; Gasparetto C; Department of Medicine, Duke University Cancer Institute, Durham, NC, USA.; Chu MP; Cross Cancer Institute, Edmonton, AB, Canada.; Dalovisio A; Department of Hematology and Oncology, Ochsner Health, New Orleans, LA, USA.; Sebag M; Cedars Cancer Center, McGill University Health Center, Montreal, QC, Canada.; Lesokhin AM; Division of Hematology and Oncology, Memorial Sloan Kettering Cancer Center/Weill Cornell Medical College, New York, NY, USA.
Source
Publisher: Nature Publishing Company Country of Publication: United States NLM ID: 9502015 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1546-170X (Electronic) Linking ISSN: 10788956 NLM ISO Abbreviation: Nat Med Subsets: MEDLINE
Subject
Language
English
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 .
(© 2023. The Author(s).)
(© 2023. The Author(s).)