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MagnetisMM-3

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

Phase 2N = 123NCT04649359

Population
Relapsed or refractory myeloma, cohort A (no prior BCMA-directed therapy), 123 patients.
Design
Phase 2 single-arm trial of subcutaneous elranatamab once weekly after two step-up priming doses; persistent responders switched to biweekly dosing after six cycles. Cohort A enrolled patients without prior BCMA-directed therapy. The primary end point was confirmed objective response rate by blinded independent central review.
Primary endpoint
ORR
Arms
  • Elranatamab (cohort A) (experimental, n = 123): Elranatamab subcutaneously weekly, biweekly after six cycles in persistent responders
People
Lesokhin AM
Show the numbers
Results reported for MagnetisMM-3
EndpointAnalysisElranatamab (cohort A)ControlEffect
ORRCohort A (123)primarymedian follow-up 14.7 monthsLesokhin 202361%—Fifty responders switched to biweekly dosing and 40 (80.0%) improved or maintained their response for 6 months or more. Infections occurred in 69.9% (grade 3-4, 39.8%); cytokine release syndrome in 57.7% (grade 3-4, 0%). With biweekly dosing, grade 3-4 adverse events decreased from 58.6% to 46.6%.
≥CR rateCohort A (123)primaryLesokhin 202335%——
DORCohort A responders (75 of 123); time from first confirmed responseprimaryLesokhin 202371.5% at 15 mo—Median duration of response had not been reached. The 15-month rate is a Kaplan-Meier estimate among the 75 responders (open-access full text, Methods and Results).
PFSCohort A (123)primaryLesokhin 202350.9% at 15 mo—Median progression-free survival had not been reached. The 15-month rate is a Kaplan-Meier estimate timed from the first dose in all 123 patients (open-access full text, Methods).
OSCohort A (123)primaryLesokhin 202356.7% at 15 mo—Median overall survival had not been reached. The 15-month rate is a Kaplan-Meier estimate timed from the first dose in all 123 patients (open-access full text, Methods).
Results reported for MagnetisMM-3
EndpointAnalysisElranatamab (cohort A)ControlEffect
ORRCohort A (123)primarymedian follow-up 14.7 monthsLesokhin 202361%—Fifty responders switched to biweekly dosing and 40 (80.0%) improved or maintained their response for 6 months or more. Infections occurred in 69.9% (grade 3-4, 39.8%); cytokine release syndrome in 57.7% (grade 3-4, 0%). With biweekly dosing, grade 3-4 adverse events decreased from 58.6% to 46.6%.
≥CR rateCohort A (123)primaryLesokhin 202335%——
DORCohort A responders (75 of 123); time from first confirmed responseprimaryLesokhin 202371.5% at 15 mo—Median duration of response had not been reached. The 15-month rate is a Kaplan-Meier estimate among the 75 responders (open-access full text, Methods and Results).
PFSCohort A (123)primaryLesokhin 202350.9% at 15 mo—Median progression-free survival had not been reached. The 15-month rate is a Kaplan-Meier estimate timed from the first dose in all 123 patients (open-access full text, Methods).
OSCohort A (123)primaryLesokhin 202356.7% at 15 mo—Median overall survival had not been reached. The 15-month rate is a Kaplan-Meier estimate timed from the first dose in all 123 patients (open-access full text, Methods).
Primary publication: Lesokhin AM, Tomasson MH, Arnulf B, Bahlis NJ, Miles Prince H, Niesvizky R, et al. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023;29(9):2259-2267. PubMedDOI

Appears in

Sources

  1. Lesokhin AM, Tomasson MH, Arnulf B, Bahlis NJ, Miles Prince H, Niesvizky R, et al. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023;29(9):2259-2267.

    PubMedDOI