Pfizer, Astellas’ Xtandi Combo Extends Survival in Early Prostate Cancer

The combination of Xtandi (enzalutamide) and leuprolide* has been shown to significantly improve overall survival in patients with *non-metastatic hormone-sensitive prostate cancer (nmHSPC) and high-risk biochemical recurrence following curative-intent treatment145.

This survival benefit was demonstrated in the Phase 3 EMBARK trial, where the combo was compared against placebo plus leuprolide, meeting the secondary endpoint of overall survival (OS) with a statistically significant and clinically meaningful improvement15.

Xtandi as a single agent (monotherapy) did not reach statistical significance for overall survival compared to placebo or leuprolide, although favorable trends were observed15.

These results make the Xtandi-leuprolide regimen the first and only androgen receptor inhibitor-based treatment to demonstrate an overall survival benefit for this patient population1.

The safety profile of the Xtandi combination was consistent with previous studies; no new safety signals were reported5.

Full survival results will be presented at an upcoming medical meeting, according to Pfizer and Astellas5.

Sources:

1. https://www.fiercepharma.com/pharma/pfizer-astellas-xtandi-bolsters-its-early-stage-prostate-cancer-case-mixed-bag-survival-win

4. https://www.indianpharmapost.com/news/pfizer-and-astellas-xtandi-combo-extends-survival-in-early-prostate-cancer-setting-17396

5. https://www.clinicaltrialsarena.com/news/pfizer-astellas-xtandi-improves-os-combination-therapy/