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news.A phase 4 study found that continuing treatment with Pfizer's cancer drug Xtandi (enzalutamide) in addition to a regimen of Zytiga and a steroid failed to show treatment benefit in patients with advanced prostate cancer.
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The continued treatment with Xtandi , plus abiraterone acetate and prednisone as compared to treatment with abiraterone acetate and prednisone alone, did not meet its primary endpoint of improvement in progression-free survival (PFS) in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (CRPC) whose prostate-specific antigen (PSA) has previously progressed on Xtandi .
In October 2009, Medivation, which is now part of Pfizer, and Astellas Pharma signed a global agreement to jointly develop and commercialize enzalutamide.
The companies are working on a development program that includes studies to develop enzalutamide across the entire spectrum of advanced prostate cancer as well as advanced breast cancer
Xtandi is an androgen receptor inhibitor that stops multiple steps in the androgen receptor signaling pathway within the tumor cell, was jointly developed by Medivation and Astellas Pharma.
Medivation interim chief medical officer Mohammad Hirmand said: “While the PLATO trial did not meet its primary endpoint, it is critical that we continue to focus on addressing the unmet needs of men with metastatic CRPC, who have a poor prognosis despite treatment advances.
“We will continue to analyze these data to better understand the results with the goal of further helping these patients.”
More tehn 500 patients took part in thre randomized, double-blind, placebo-controlled, two-period efficacy and safety phase 4 study.
Eligible patients were randomly subjected to either of the two treatments, Xtandi plus abiraterone acetate and prednisone, and abiraterone acetate and prednisone alone and assessed for their PFS.
Astellas senior vice president, oncology development therapeutic area head Steven Benner said: “Xtandi continues to remain an important treatment option for men with metastatic CRPC and their physicians. We are committed to continuing to explore the clinical potential of Xtandi across the disease continuum.
Currently, Xtandi has the US Food and Drug Administration approval to be used in treatment of metastatic CRPC patients.