Pfizer Inc. 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 (RRMM) who received at least one prior line of treatment.
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression‑free survival (PFS), as assessed by blinded independent central review (BICR), versus standard-of-care daratumumab plus pomalidomide and dexamethasone (DPd). The safety and tolerability of ELREXFIO was consistent with its known safety profile.
The PFS results exceeded the pre-specified interim analysis target hazard ratio for efficacy, with most ELREXFIO-treated patients remaining progression-free. The trial remains ongoing to assess overall survival, a key secondary endpoint, which was not yet mature at the time of this interim analysis. These data will be discussed with global health authorities, and detailed results from MagnetisMM-5 will be submitted for presentation at a future medical congress.
Multiple myeloma is an aggressive and currently incurable blood cancer that affects plasma cells made in the bone marrow. It is the second most common type of blood cancer worldwide, with over 36,000 new cases each year in the US and over 187,000 globally. Despite treatment advances, most patients relapse and develop relapsed or refractory disease, often requiring multiple lines of therapy, with approximately 40% not surviving beyond five years.
Multiple myeloma can significantly impact quality of life, with immune suppression increasing susceptibility to infection, and symptoms such as fatigue, bone pain, and psychological distress making everyday activities more difficult.
“Effective intervention earlier in the course of disease represents a critical opportunity to improve outcomes for people living with multiple myeloma,” said Jeff Legos, chief oncology officer at Pfizer.
“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.”
ELREXFIO is approved in more than 35 countries worldwide, including in the United States where it received accelerated approval for use in adults with RRMM who have received at least four prior lines of therapy, and in the European Union where it was granted conditional marketing authorization for adults with RRMM who have received at least three prior therapies and have demonstrated disease progression on the last therapy.
MagnetisMM-5 is part of a comprehensive development program in double-class exposed MM patients. The program includes the fully recruited phase 3 MagnetisMM-32 study, which is designed to evaluate ELREXFIO in patients who have previously received daratumumab as part of standard-of-care front-line MM treatment.