TY - JOUR
T1 - Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results
AU - Lesokhin, Alexander M.
AU - Tomasson, Michael H.
AU - Arnulf, Bertrand
AU - Bahlis, Nizar J.
AU - Miles Prince, H.
AU - Niesvizky, Ruben
AU - Rodrίguez-Otero, Paula
AU - Martinez-Lopez, Joaquin
AU - Koehne, Guenther
AU - Touzeau, Cyrille
AU - Jethava, Yogesh
AU - Quach, Hang
AU - Depaus, Julien
AU - Yokoyama, Hisayuki
AU - Gabayan, Afshin Eli
AU - Stevens, Don A.
AU - Nooka, Ajay K.
AU - Manier, Salomon
AU - Raje, Noopur
AU - Iida, Shinsuke
AU - Raab, Marc-Steffen
AU - Searle, Emma
AU - Leip, Eric
AU - Sullivan, Sharon T.
AU - Conte, Umberto
AU - Elmeliegy, Mohamed
AU - Czibere, Akos
AU - Viqueira, Andrea
AU - Mohty, Mohamad
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
U2 - 10.1038/s41591-023-02528-9
DO - 10.1038/s41591-023-02528-9
M3 - Article
SN - 1546-170X
VL - 29
SP - 2259
EP - 2267
JO - Nature Medicine
JF - Nature Medicine
IS - 9
ER -
