Elranatamab Improves PFS vs Standard Regimens in R/R Multiple Myeloma

Elranatamab-bcmm (Elrexfio) monotherapy produced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with investigator’s choice of standard-of-care regimens in patients with relapsed or refractory multiple myeloma who had received prior anti-CD38 therapy and lenalidomide (Revlimid), meeting the primary end point of the phase 3 MagnetisMM-32 trial (NCT06152575), according to topline results announced by the developer, Pfizer.¹

What did the interim analysis show?

At the prespecified interim efficacy analysis, elranatamab demonstrated a statistically significant and clinically meaningful reduction in the risk of disease progression or death compared with investigator’s choice of elotuzumab (Empliciti), pomalidomide (Pomalyst), and dexamethasone (EloPd); pomalidomide, bortezomib (Velcade), and dexamethasone (PVd); or carfilzomib (Kyprolis) and dexamethasone (Kd). The median PFS by blinded independent central review (BICR) had not yet been reached with elranatamab. More than 75% of patients receiving elranatamab had not experienced disease progression or death from any cause at the time of the analysis, with an estimated 18-month PFS rate of 68%.

Overall survival (OS), a key secondary end point, remained immature at the time of the analysis, and follow-up will continue to the next prespecified OS analysis. According to Pfizer, 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 3 established regimens.

What was the safety profile?

The safety profile of elranatamab 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 or higher infections were observed in 27.5% of patients receiving elranatamab vs 18.1% of patients receiving investigator’s choice of therapy, and grade 5 infections were observed in 0.8% vs 1.6% of patients, respectively.

What did the investigators say?

“These findings further strengthen the rationale for moving BCMA-directed therapy earlier in the treatment journey and underscore [elranatamab’s] potential to help redefine outcomes for patients,” said C. Ola Landgren, MD, PhD, a professor of medicine, chief of the Myeloma Division, and director of the Sylvester Myeloma Institute at the University of Miami Miller School of Medicine, in the press release.¹ He added that the results were “particularly compelling given the rigorous and clinically relevant benchmark of [3] established standard-of-care regimens.”

What was the trial design?

MagnetisMM-32 is an open-label, multicenter, randomized phase 3 study evaluating the efficacy and safety of elranatamab monotherapy vs investigator’s choice among 3 standard-of-care regimens (EloPd, PVd, or Kd) in patients with relapsed/refractory multiple myeloma.² The study enrolled 523 adults across 26 countries who had received at least 1 prior line of treatment with anti-CD38 therapy—daratumumab (Darzalex) or isatuximab (Sarclisa)—and lenalidomide. Patients received subcutaneous elranatamab as 2 step-up priming doses followed by weekly doses in a 28-day cycle, transitioning to every 2 weeks and then monthly dosing.

The primary end point was PFS by BICR. The key secondary end point was OS.

What are the implications and next steps?

The findings build on previously announced positive topline results from MagnetisMM-5 (NCT05020236), the first phase 3 study of elranatamab to read out in double-class–exposed relapsed/refractory multiple myeloma, and reinforce the evidence supporting elranatamab monotherapy in earlier lines of relapsed/refractory disease.³ Pfizer plans to submit the MagnetisMM-32 data to global health authorities, with detailed results to be shared at a future medical meeting and submitted for publication.

Elranatamab is a subcutaneously delivered BCMA/CD3–directed bispecific antibody that is approved in more than 35 countries; in the US, it holds accelerated approval for adults with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy.

“MagnetisMM-32 demonstrates that [elranatamab], an off-the-shelf, fixed-dose monotherapy, delivers a significant and clinically meaningful [PFS] 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,” said Jeff Legos, chief oncology officer at Pfizer, in the news 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 Inc. October 27, 2026. Accessed October 27, 2026. https://tinyurl.com/ycx5y3pm
2. 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) (MagnetisMM-32). ClinicalTrials.gov. Updated August 24, 2026. Accessed October 27, 2026. https://tinyurl.com/2fjkzxjv
3. Pfizer’s Elrexfio significantly improves progression-free survival for double-class exposed patients with relapsed or refractory multiple myeloma. News release. Pfizer. April 29, 2026. Accessed October 27, 2026. https://tinyurl.com/43nmxye6