Pfizer Inc. and Astellas Pharma Inc. announced that their Phase 3 PROSPER trial evaluating Xtandi® (enzalutamide) plus androgen deprivation therapy (ADT) versus ADT alone in men with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC) met its primary endpoint of improved metastasis-free survival (MFS). They also said that the preliminary safety analysis of the trial appears consistent with the safety profile of Xtandi in previous clinical trials.
“Many prostate cancer patients who initiate androgen deprivation therapy will experience disease progression illustrated by a rising PSA level, and currently, there are no FDA-approved treatment options for patients with non-metastatic CRPC until they develop confirmed radiographic metastatic disease,” said Neal Shore, M.D., director, CPI, Carolina Urologic Research Center.
At this point, the data will need to be submitted and reviewed with global health authorities for them to expand Xtandi’s label for to cover all men with CRPC. Also, the data will need to be presented to peer review journals and at medical meetings.
Xtandi is currently approved only for the treatment of metastatic CRPC based on clinical data from previous studies that showed a statistically significant overall survival benefit for XTANDI versus placebo in the metastatic CRPC setting. If the data holds up and the proper approvals are secured it will also be approved for men with castrate resistant prostate cancer who do not have any identified metastasis.
Joel T. Nowak, MA, MSW wrote this Post. Joel is the CEO/Executive Director of Cancer ABCs. He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and Appendiceal Cancer a rare cancer.