Pfizer and Astellas Pharma have reported positive topline data from the Phase III EMBARK trial of Xtandi (enzalutamide) in non-metastatic, hormone-sensitive prostate cancer men with high-risk biochemical recurrence (BCR).

The placebo-controlled, randomised, multi-national, double-blind Phase III trial has been designed to evaluate enzalutamide, along with leuprolide, in patients whose disease is still progressing following a radical prostatectomy, radiotherapy, or both.

A total of 1,068 non-metastatic, hormone-sensitive prostate cancer patients with high-risk BCR were enrolled at sites in Europe, South America, Canada, the US, and the Asia-Pacific region.

In the trial, participants were randomised into one of three study arms to receive Xtandi along with leuprolide, a placebo along with leuprolide, or Xtandi monotherapy.

According to the findings, participants treated with Xtandi along with leuprolide had statistically significant and clinically meaningful improvements in their metastasis-free survival (MFS) compared to those who received a placebo plus leuprolide.

Additionally, patients treated with Xtandi alone had statistically significant and clinically meaningful improvements in MFS compared to a placebo along with leuprolide.

Pfizer Global Product Development Oncology and Rare Disease chief development officer Chris Boshoff said: “As the only novel hormone therapy approved for three disease states of prostate cancer in the US, Xtandi has impacted hundreds of thousands of men.

“The topline findings from EMBARK are highly encouraging and we look forward to engaging with health authorities to potentially bring Xtandi to men with non-metastatic, hormone-sensitive prostate cancer with high-risk biochemical recurrence.”

The company stated that the detailed data from the EMBARK trial will be used for regulatory submission with authorities for Xtandi in this indication, including the US Food and Drug Administration (FDA).