Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (OTC:ALPMF) (OTC:ALPMY) on Thursday released topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating Xtandi (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer with biochemical recurrence (BCR) at high risk for metastasis.
For patients treated with Xtandi plus leuprolide versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically significant and clinically meaningful improvement in OS.
There was a favorable trend in results towards improved OS for patients treated with Xtandi monotherapy versus placebo plus leuprolide; however, the difference did not reach statistical significance.
No new safety signals were observed in the analysis, and the safety results were consistent with Xtandi’s demonstrated safety profile.
In the EMBARK study, patients were randomized to one of three study arms: Xtandi plus leuprolide, placebo plus leuprolide or XTANDI monotherapy.
An initial analysis was previously reported in The New England Journal of Medicine in 2023, demonstrating that the study met its primary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with Xtandi plus leuprolide versus placebo plus leuprolide.
The most common adverse events (occurring in ≥10% of patients) in the combination group and the leuprolide-alone group were hot flashes and fatigue. The most common adverse events in the monotherapy group were gynecomastia, hot flashes, and fatigue.
Xtandi is approved in over 80 countries, including the U.S., the EU and Japan.
Detailed OS results from EMBARK will be presented at a future medical meeting.
In May, Astellas and Pfizer announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES study, reporting a five-year follow-up of overall survival (OS) benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer (mHSPC) treated with Xtandi plus androgen deprivation therapy (ADT) compared to placebo plus ADT.
In March, the U.S. Food and Drug Administration (FDA) on Friday approved Novartis AG's (NYSE:NVS) Pluvicto for prostate cancer patients.
The expanded indication, which approximately triples the number of patients eligible to receive Pluvicto, is based on the Phase 3 PSMAfore trial results.
Novartis is investigating Pluvicto in earlier stages of the disease, including metastatic hormone-sensitive prostate cancer and oligometastatic prostate cancer.
PFE, ALPMY Price Actions: Pfizer stock is up 1.13% at $25.85; Astellas is down 0.64% at $9.40 at publication on Thursday.
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