October 27, 2026 --NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced topline results from the Phase 3 MagnetisMM-32 study evaluating ELREXFIO® (elranatamab) as monotherapy in adults with relapsed or refractory multiple myeloma (RRMM) who received at least one prior line of treatment with anti-CD38 therapy (daratumumab or isatuximab) and lenalidomide.
At the pre-specified interim analysis for efficacy, the study met its primary endpoint of progression-free survival (PFS) as assessed by blinded independent central review (BICR). ELREXFIO demonstrated a statistically significant and clinically meaningful reduction in the risk of disease progression or death versus investigator’s choice of elotuzumab, pomalidomide and dexamethasone (EloPd); pomalidomide, bortezomib and dexamethasone (PVd); or carfilzomib and dexamethasone (Kd). MagnetisMM-32 used one of the broadest standard-of-care comparators in a Phase 3 BCMA bispecific trial in this setting, with investigator’s choice of three established regimens.
More than 75% of patients receiving ELREXFIO had not experienced disease progression or death from any cause at the time of the analysis1, with an estimated 68% PFS at 18 months. Data for overall survival (OS), a key secondary endpoint, remain immature, and follow-up will continue to the next pre-specified OS analysis.
The safety profile of ELREXFIO in MagnetisMM-32 was consistent with its known profile and no new safety signals were identified. Infection prophylaxis measures instituted from the beginning of the study helped mitigate infection risk, including Grade 3 or higher infections. Grade ≥3 infections were observed in 27.5% of patients receiving ELREXFIO vs. 18.1% of patients on investigator’s choice, and Grade 5 infections were observed in 0.8% of patients receiving ELREXFIO vs 1.6% of patients on investigator’s choice.
Pfizer plans to submit these data to global health authorities, with detailed results to be shared at a future medical meeting and submitted for publication.
“The treatment landscape for multiple myeloma continues to evolve as anti-CD38-based regimens and lenalidomide are increasingly used earlier in care. Yet many patients ultimately experience disease progression, with limited treatment options available following these commonly used therapies. MagnetisMM-32 demonstrates that ELREXFIO, an off-the-shelf, fixed-dose monotherapy, delivers a significant and clinically meaningful progression-free survival benefit and an encouraging safety profile in this increasingly important treatment setting, with median PFS not yet reached and a high percentage of patients remaining progression-free at the time of analysis. These findings further strengthen the rationale for moving BCMA-directed therapy earlier in the treatment journey and underscore ELREXFIO's potential to help redefine outcomes for patients.”
– Jeff Legos, Chief Oncology Officer, Pfizer
“The MagnetisMM-32 results are particularly compelling given the rigorous and clinically relevant benchmark of three established standard-of-care regimens. Demonstrating a significant progression-free survival benefit against this active control highlights the potential of elranatamab-bcmm to provide an important treatment option for patients whose disease has progressed following anti-CD38 therapy and lenalidomide.”
– C. Ola Landgren, Professor of Medicine, Chief of Myeloma Division and Director of Sylvester Myeloma Institute, University of Miami Miller School of Medicine
About the Phase 3 MagnetisMM-32 Study
These data build on the positive topline results previously announced from MagnetisMM-5, the first Phase 3 study of ELREXFIO to read out in double-class exposed RRMM, and reinforce the evidence supporting ELREXFIO monotherapy in earlier lines of RRMM. The MagnetisMM-32 findings show that ELREXFIO has the potential to address a significant unmet need for patients whose disease has progressed following anti-CD38 therapy and lenalidomide, a growing population that often faces poorer outcomes and has limited treatment options.2,3
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MagnetisMM-32 is an open-label, multicenter, randomized Phase 3 study to evaluate the efficacy and safety of ELREXFIO monotherapy versus investigator’s choice among three standard-of-care regimens (EloPd; PVd; Kd) in patients with RRMM.
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The study enrolled 523 adults across 26 countries who received at least one prior line of treatment with anti-CD38 therapy and lenalidomide.
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Participants received subcutaneous ELREXFIO as two step-up priming doses followed by weekly doses in a 28-day cycle and transitioned to every two weeks and then monthly doses.
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The primary endpoint is PFS by BICR and the key secondary endpoint is OS.
Pfizer’s Robust Multiple Myeloma Development Program
The MagnetisMM-32 study reflects an important treatment setting because many patients with RRMM experience relapse following commonly used frontline therapies and may face poorer outcomes and limited treatment options as their disease progresses.2,3 Together with the positive MagnetisMM-5 topline results, the MagnetisMM-32 findings bolster the evidence supporting ELREXFIO monotherapy in earlier lines of treatment for RRMM.
Pfizer is continuing to evaluate ELREXFIO across the multiple myeloma treatment continuum, both as a monotherapy and in combination approaches, including in newly diagnosed multiple myeloma through the ongoing Phase 3 studies MagnetisMM-6, MagnetisMM-7 and the ElLen study (IFM 2025-01, led by the Intergroupe Francophone du Myélome).
About ELREXFIO (elranatamab)
ELREXFIO is a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody immunotherapy that binds to BCMA on myeloma cells and CD3 on T cells, activating the T cells to kill myeloma cells.
ELREXFIO is approved and marketed in more than 35 countries worldwide. In the U.S., 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, 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.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us.
REFERENCES
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Progression-free survival (PFS) event
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Gandhi UH, Cornell RF, Lakshman A, et al. Outcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy. Leukemia. 2019;33(9):2266-2275. doi:10.1038/s41375-019-0435-7
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Ramasamy K, Vij R, Kuter D, et al. Real-world treatment patterns and clinical outcomes in patients with multiple myeloma previously treated with lenalidomide and an anti-CD38 monoclonal antibody. Clin Lymphoma Myeloma Leuk. 2025;25(5):337-348.e2. doi:10.1016/j.clml.2024.12.002