Pfizer Inc. (NYSE:PFE) on Tuesday released topline results from its Phase 3 MagnetisMM-32 study evaluating Elrexfio (elranatamab) as a monotherapy.
• Pfizer stock is showing upward bias. What’s next for PFE stock?
The trial studied adult patients with relapsed or refractory multiple myeloma who previously received at least one line of therapy, including an anti-CD38 agent and lenalidomide.
Strong Progression-Free Survival Results
The study achieved its primary endpoint of progression-free survival at a pre-specified interim efficacy analysis.
Elrexfio demonstrated a statistically significant and clinically meaningful reduction in the risk of disease progression or death compared to three standard-of-care regimens selected by investigators.
More than 75% of patients receiving Elrexfio avoided disease progression or death at the time of analysis, showing an estimated 68% progression-free survival rate at 18 months.
Secondary endpoint data for overall survival remain immature, and researchers will continue monitoring patients until the next scheduled analysis.
Safety Profile and Regulatory Plans
ELREXFIO demonstrated a safety profile consistent with its known characteristics, generating no new safety signals.
Early infection prophylaxis measures helped mitigate infection risks. Grade 3 or higher infections developed in 27.5% of patients receiving Elrexfio versus 18.1% on investigator’s choice, while Grade 5 infections occurred in 0.8% of Elrexfio patients compared to 1.6% in the control group.
FDA Approval for Prostate Cancer Drug
On Monday, the U.S. Food and Drug Administration (FDA) approved Pfizer’s talazoparib (Talzenna) in combination with enzalutamide for mutated prostate cancer.
The approval covers adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with homologous recombination repair gene mutations, as detected by an FDA-authorized test.
PFE Price Action: Pfizer shares were down 0.32% at $29.70 at the time of publication on Tuesday, according to Benzinga Pro data.
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