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Pfizer, Astellas Say Final PROSPER Results Show XTANDI Extends Overall Survival

Pfizer Inc. (PFE) and Japan-based Astellas Pharma Inc. (ALPMY) on Friday announced final results from the overall survival or OS analysis of the Phase 3 PROSPER trial.

According to the two companies, the final PROSPER results showed XTANDI, or enzalutamide, significantly extends overall survival in men with non-metastatic castration-resistant prostate cancer.

The trial evaluated XTANDI plus androgen deprivation therapy or ADT versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC).

The companies noted that in the trial, XTANDI plus ADT reduced the risk of death by 27 percent compared to placebo plus ADT. The median OS was 67.0 months for men who received XTANDI plus ADT, compared to 56.3 months with placebo plus ADT. OS was a key secondary endpoint of the trial.

The two companies also said that the data was simultaneously published online in the New England Journal of Medicine and presented during the virtual scientific program of the 2020 American Society of Clinical Oncology or ASCO Annual Meeting.

The safety profile observed in the final OS analysis was consistent with the 2018 primary analysis and the established safety profile of enzalutamide.

"Overall survival is a critical endpoint in evaluating a prostate cancer medicine. These results add to the body of evidence supporting XTANDI's potential to reduce the risk of death in men with castration-resistant prostate cancer," said Cora Sternberg, Clinical Director, Englander Institute for Precision Medicine and Professor of Medicine in Hematology & Oncology, Weill Cornell Medicine and NewYork-Presbyterian.

The Phase 3 randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,401 patients with nmCRPC at sites in the U.S., Canada, Europe, South America and the Asia-Pacific region.

PROSPER enrolled patients with prostate cancer that had progressed, based on a rising PSA level despite ADT, but who had no symptoms and no prior or present evidence of metastatic disease.

Of the total patients enrolled, 933 patients were treated with XTANDI at a dose of 160 mg taken orally once daily plus ADT, and 468 patients were treated with placebo plus ADT.

The primary endpoint of the PROSPER trial, metastasis-free survival or MFS, was measured as the time from patients entering the trial until their cancer was radiographically detected as having metastasized, or until death, within 112 days of treatment discontinuation.

Key secondary endpoints included OS, time to PSA progression and time to first use of antineoplastic therapy.

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