Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results

Alexander M. Lesokhin(Memorial Sloan Kettering Cancer Center), Michael H. Tomasson(University of Iowa), Bertrand Arnulf(Hôpital Saint-Louis), Nizar J. Bahlis(University of Calgary), H. Miles Prince(The University of Melbourne), Rubén Niesvizky(NewYork–Presbyterian Hospital), Paula Rodríguez‐Otero(Clinica Universidad de Navarra), Joaquín Martínez‐López(Hospital Universitario 12 De Octubre), Guenther Koehne(Miami Heart Research Institute), Cyrille Touzeau(Centre Hospitalier Universitaire de Nantes), Yogesh Jethava(Indiana Cancer Consortium), Hang Quach(The University of Melbourne), Julien Depaus(UCLouvain), Hisayuki Yokoyama(Tohoku University), Afshin Eli Gabayan(Beverly Hills Cancer Center), Don A. Stevens(Norton Healthcare), Ajay K. Nooka(Piedmont Cancer Institute), Salomon Manier(Inserm), Noopur Raje(Harvard University), Shinsuke Iida(Nagoya City University), Marc S. Raab(Heidelberg University), Emma Searle(University of Manchester), Eric Leip(Pfizer (United States)), Sharon T. Sullivan(Pfizer (United States)), Umberto Conte(Pfizer (United States)), Mohamed Elmeliegy(Pfizer (United States)), Akos Czibere(Pfizer (United States)), Andrea Viqueira(Saint Louis University), Mohamad Mohty(Inserm)
Nature Medicine
August 15, 2023
Cited by 537Open Access
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Abstract

Elranatamab is a humanized B-cell maturation antigen (BCMA)-CD3 bispecific antibody. In the ongoing phase 2 MagnetisMM-3 trial, patients with relapsed or refractory multiple myeloma received subcutaneous elranatamab once weekly after two step-up priming doses. After six cycles, persistent responders switched to biweekly dosing. Results from cohort A, which enrolled patients without prior BCMA-directed therapy (n = 123) are reported. The primary endpoint of confirmed objective response rate (ORR) by blinded independent central review was met with an ORR of 61.0% (75/123); 35.0% ≥complete response. Fifty responders switched to biweekly dosing, and 40 (80.0%) improved or maintained their response for ≥6 months. With a median follow-up of 14.7 months, median duration of response, progression-free survival and overall survival (secondary endpoints) have not been reached. Fifteen-month rates were 71.5%, 50.9% and 56.7%, respectively. Common adverse events (any grade; grade 3-4) included infections (69.9%, 39.8%), cytokine release syndrome (57.7%, 0%), anemia (48.8%, 37.4%), and neutropenia (48.8%, 48.8%). With biweekly dosing, grade 3-4 adverse events decreased from 58.6% to 46.6%. Elranatamab induced deep and durable responses with a manageable safety profile. Switching to biweekly dosing may improve long-term safety without compromising efficacy. ClinicalTrials.gov identifier: NCT04649359 .


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