Pfizer's Elrexfio Meets Phase III Primary Endpoint in Multiple Myeloma, Positioning Drug for Earlier-Line Use

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Elrexfio met its primary endpoint in the Phase III MagnetisMM-5 trial, demonstrating statistically significant and clinically meaningful improvement in progression-free survival versus standard-of-care daratumumab plus pomalidomide and dexamethasone13

The trial enrolled 497 patients across 26 countries with relapsed or refractory multiple myeloma who had received at least one prior line of treatment, including lenalidomide and a proteasome inhibitor5

Most Elrexfio-treated patients remained progression-free at the time of interim analysis, with PFS results exceeding the pre-specified interim analysis target hazard ratio for efficacy13

Safety was consistent with Elrexfio's established profile, with no new safety signals identified13

Overall survival, a key secondary endpoint, was not yet mature and the trial continues13

Elrexfio is a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody that activates T cells to kill myeloma cells35

The positive results position Elrexfio as a potential earlier-line treatment option, addressing a critical unmet need in multiple myeloma where patients typically cycle through multiple regimens15

Elrexfio received FDA accelerated approval in August 2023 for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, and is now approved in more than 35 countries45

Sources:

1. https://allsci.com/news/clinical-trials/pfizers-elranatamab-meets-phase-iii-primary-endpoint-in-relapsed-or-refractory-multiple-myeloma/

3. https://www.businesswire.com/news/home/20260428420063/en/Pfizers-ELREXFIO-Significantly-Improves-Progression-Free-Survival-for-Double-Class-Exposed-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma

4. https://www.valuebasedcancer.com/categories/fda-approvals-news-updates/fda-grants-accelerated-approval-to-elrexfio-for-relapsed-or-refractory-multiple-myeloma

5. https://www.stocktitan.net/news/PFE/pfizer-s-elrexfio-significantly-improves-progression-free-survival-kttrltvv5qv0.html