Pfizer Inc. (NYSE: PFE) announced that its drug ELREXFIO met the primary endpoint in a Phase 3 trial for patients with relapsed or refractory multiple myeloma. The MagnetisMM-5 study demonstrated statistically significant improvement in progression-free survival compared to standard-of-care treatment with daratumumab plus pomalidomide and dexamethasone.

The trial enrolled 497 patients across 26 countries who had received at least one prior line of treatment, including lenalidomide and a proteasome inhibitor. Participants received subcutaneous ELREXFIO injections following a step-up dosing schedule, with treatment frequency adjusted based on response.

The progression-free survival results exceeded the pre-specified interim analysis target hazard ratio for efficacy, with most ELREXFIO-treated patients remaining progression-free. The trial continues to assess overall survival, a key secondary endpoint that was not yet mature at the time of this interim analysis.

Safety and tolerability of ELREXFIO remained consistent with its known safety profile, with no new safety signals identified during the study. The company plans to discuss these data with global health authorities and submit detailed results for presentation at a future medical congress.

ELREXFIO is currently approved in more than 35 countries worldwide. In the United States, it received accelerated approval for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The European Union granted conditional marketing authorization for adults who have received at least three prior therapies.

Multiple myeloma affects over 36,000 new patients annually in the United States and over 187,000 globally. Despite treatment advances, most patients experience relapses and require multiple lines of therapy, with approximately 40% not surviving beyond five years.