Pfizer’s Elrexfio significantly improves progression-free survival in relapsed or refractory multiple myeloma

Pfizer has announced positive topline results from the Phase 3 MagnetisMM-5 study evaluating Elrexfio (elranatamab) as monotherapy in adults with relapsed or refractory multiple myeloma who had received at least one prior line of treatment. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared with standard-of-care daratumumab plus pomalidomide and dexamethasone. The PFS results exceeded the pre-specified interim analysis target hazard ratio, with most Elrexfio-treated patients remaining progression-free at the time of the analysis. Safety was consistent with the known Elrexfio profile, with no new signals identified.

Multiple myeloma is the second most common blood cancer worldwide, with over 36,000 new cases each year in the United States and more than 187,000 globally. Despite treatment advances, most patients relapse and require multiple lines of therapy, with approximately 40% not surviving beyond five years. The disease also carries a significant quality of life burden, with immune suppression, fatigue, bone pain and psychological distress making everyday activities more difficult.

Jeff Legos, Chief Oncology Officer at Pfizer, emphasised the importance of moving effective treatment earlier in the disease course: “Elrexfio has already helped address a significant unmet need in heavily pre-treated patients, delivering deep, durable, and clinically meaningful responses. The MagnetisMM-5 results reinforce our confidence in Elrexfio’s potential to benefit patients earlier in their treatment journey and support our comprehensive strategy to evaluate Elrexfio both as monotherapy and as part of combination approaches across multiple lines of therapy.”

The trial remains ongoing to assess overall survival, a key secondary endpoint that was not yet mature at this interim analysis. Detailed results will be submitted for presentation at a future medical congress and discussed with global health authorities.

Elrexfio is currently approved in more than 35 countries, including accelerated approval in the US for patients who have received at least four prior lines of therapy, and conditional marketing authorisation in the EU for patients who have received at least three prior therapies and demonstrated disease progression on the last. The MagnetisMM-5 programme forms part of a broader development strategy that also includes the fully recruited Phase 3 MagnetisMM-32 study, evaluating Elrexfio in patients who previously received daratumumab as part of front-line treatment.

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Related Topics and Keywords

elrexifo, multiple myeloma, Pfizer’s ELREXFIO®, Relapsed and Refractory Multiple Myeloma