Xtandi Shows Promise in Prostate Cancer Trial

Pfizer and Astellas Pharma announced positive topline results from a phase 3 trial of Xtandi (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).

The companies said the study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with Xtandi plus leuprolide versus placebo plus leuprolide.

The study also met a key secondary endpoint with improvement in MFS for patients treated with Xtandi monotherapy versus placebo plus leuprolide.

The companies said they plan to discuss these results with the FDA in support of a potential regulatory submission for Xtandi for this indication.

Xtandi has regulatory approvals for use in men with mHSPC, mCRPC and nmCRPC in the U.S. and for one or more of these indications in more than 100 countries.