ELREXFIO improves progression-free survival in Phase III relapsed multiple myeloma trial

Pfizer has reported positive topline Phase III results showing that ELREXFIO, also known as elranatamab, significantly improved progression-free survival in adults with relapsed or refractory multiple myeloma.

The findings come from the MagnetisMM-32 study, which evaluated ELREXFIO as a monotherapy in patients who had received at least one previous line of treatment containing an anti-CD38 therapy and lenalidomide.

At the prespecified interim efficacy analysis, the study met its primary endpoint of progression-free survival as assessed by blinded independent central review.

ELREXFIO produced a statistically significant and clinically meaningful reduction in the risk of disease progression or death compared with investigator’s choice of established standard regimens.

The control options included elotuzumab, pomalidomide and dexamethasone, known as EloPd, pomalidomide, bortezomib and dexamethasone, or PVd, and carfilzomib plus dexamethasone, or Kd.

Pfizer said more than 75% of patients receiving ELREXFIO had not experienced disease progression or death at the time of the analysis.

Estimated progression-free survival at 18 months was 68%.

Median progression-free survival had not yet been reached in the ELREXFIO group.

Overall survival data, a key secondary endpoint, remained immature at the interim analysis and follow-up is continuing.

Jeff Legos, Chief Oncology Officer at Pfizer, said the findings support moving BCMA-directed treatment earlier in the multiple myeloma treatment pathway, particularly as anti-CD38 therapies and lenalidomide are increasingly used in earlier lines.

He said MagnetisMM-32 demonstrated a meaningful progression-free survival benefit with an off-the-shelf, fixed-dose monotherapy in a patient population with limited options following commonly used treatments.

C. Ola Landgren, Professor of Medicine and Chief of the Myeloma Division at the University of Miami Miller School of Medicine, said the results were notable because ELREXFIO was compared against three established active standard-of-care regimens rather than a single comparator.

The safety profile of ELREXFIO in MagnetisMM-32 was consistent with its established profile and no new safety signals were identified.

Pfizer said infection prevention measures were implemented from the start of the study to reduce the risk of serious infections.

Grade 3 or higher infections occurred in 27.5% of patients receiving ELREXFIO compared with 18.1% of those receiving investigator’s choice.

Grade 5 infections were reported in 0.8% of patients receiving ELREXFIO and 1.6% of patients in the comparator group.

ELREXFIO is a BCMA-directed bispecific antibody designed to engage both BCMA on multiple myeloma cells and CD3 on T cells to promote an immune response against the cancer.

Pfizer plans to submit the MagnetisMM-32 findings to health authorities globally.

Detailed data from the study are expected to be presented at a future medical meeting and submitted for publication.

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Related Topics and Keywords

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