Elranatamab Improves PFS in Relapsed/Refractory Multiple Myeloma

Elranatamab-bcmm (Elrexfio) monotherapy significantly improved progression-free survival (PFS) vs investigator’s choice of standard regimens in patients with relapsed or refractory multiple myeloma (RRMM) whose disease progressed after anti-CD38 therapy and lenalidomide (Revlimid), according to topline findings from the phase 3 MagnetisMM-32 trial (NCT06152575).^1,2

At a prespecified interim analysis, the trial met its primary end point of PFS by blinded independent central review, showing a statistically significant and clinically meaningful reduction in the risk of progression or death. Median PFS has not yet been reached in the elranatamab arm. At the time of the analysis, more than 75% of patients who received the bispecific antibody remained alive without disease progression, and the estimated 18-month PFS rate was 68%.¹

Investigators could select from 3 established control regimens: elotuzumab (Empliciti), pomalidomide (Pomalyst), and dexamethasone; pomalidomide, bortezomib (Velcade), and dexamethasone; or carfilzomib (Kyprolis) and dexamethasone. Pfizer, the developer of elranatamab, described this as one of the broadest standard-of-care comparators used to date in a phase 3 trial of a B-cell maturation antigen (BCMA) bispecific in this setting. Overall survival (OS), the key secondary end point, remains immature.¹

“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, MD, PhD, professor of medicine, chief of the Myeloma Division, and director of the Sylvester Myeloma Institute at the University of Miami Miller School of Medicine, said in the press release.¹

Elranatamab Safety and Infection Risk in RRMM

The safety of elranatamab in MagnetisMM-32 aligned with its established profile, and no new signals emerged. Infection prophylaxis was required from the start of the study and helped limit infection risk, including severe infections. Grade 3 or higher infections occurred in 27.5% of patients in the elranatamab arm vs 18.1% of those in the investigator’s choice arm. Grade 5 infections occurred in 0.8% and 1.6% of patients, respectively.¹

MagnetisMM-32 Trial Design and Eligibility

The open-label, multicenter, randomized study enrolled 523 adults across 26 countries.¹ Eligible patients had received 1 to 4 prior lines, including an anti-CD38 antibody daratumumab ([Darzalex] or isatuximab [Sarclisa]) and lenalidomide, and had progressed on their last line. Prior BCMA-directed or CD3-redirecting therapy was not permitted.^1,2

Elranatamab was given subcutaneously as 2 step-up priming doses followed by weekly dosing in 28-day cycles, with later transitions to every-2-week and then monthly administration.¹ Other secondary end points include response rate, minimal residual disease negativity, and quality of life.²

Patients with myeloma that progresses after anti-CD38 antibodies and lenalidomide face poor outcomes and limited options, and this population is expanding as these agents move into earlier lines.^3,4

The results follow positive topline data from the phase 3 MagnetisMM-5 trial (NCT05020236), in which elranatamab met its PFS primary end point vs daratumumab, pomalidomide, and dexamethasone among 497 patients previously treated with lenalidomide and a proteasome inhibitor; OS was immature.⁵ Elranatamab is also being evaluated in newly diagnosed disease in the phase 3 MagnetisMM-6, MagnetisMM-7, and ElLen trials. It is approved in more than 35 countries, with US accelerated approval for RRMM after at least 4 prior lines and European Union conditional authorization after at least 3 prior therapies. Pfizer plans to submit the MagnetisMM-32 data to global health authorities.¹

“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 elranatamab, 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,” Jeff Legos, chief oncology officer at Pfizer, stated in the press release.¹

REFERENCES

1. Pfizer’s ELREXFIO outperforms standard regimens and meets primary endpoint in phase 3 study in relapsed or refractory multiple myeloma. News release. Pfizer. October 27, 2026. Accessed October 27, 2026. https://tinyurl.com/5ec3vzkm

2. MagnetisMM-32: a study to learn about the study medicine called elranatamab in people with multiple myeloma (MM) that has come back after taking other treatments (including prior treatment with an anti-CD38 antibody and lenalidomide). ClinicalTrials.gov. Updated August 24, 2026. Accessed October 27, 2026. https://clinicaltrials.gov/study/NCT06152575

3. 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

4. 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

5. Phase 3 MagnetisMM-5 trial results: Elrexfio (elranatamab) significantly and clinically improves progression-free survival in RRMM patients who received at least one prior line of treatment. International Myeloma Foundation. April 2026. Accessed October 27, 2026. https://tinyurl.com/y383wyk8