Pfizer and Astellas' Xtandi has been locked in a heated prostate cancer tussle with a challenger from Johnson & Johnson and, more recently, one from Bayer. One area where the pair was looking for a win? Showing Xtandi prolonged patients' lives––and new data has done just that.
Xtandi significantly extended patients' lives over standard-of-care hormone therapy in nonmetastatic castration-resistant prostate cancer, according to an overall survival analysis from the phase 3 Prosper trial released Tuesday.
The newest survival data met the secondary endpoint for the Prosper trial, which helped Xtandi nab an FDA approval as an add-on to androgen deprivation therapy (ADT) in that hard-to-treat prostate cancer population back in July 2018.
With its overall survival data in hand—considered the gold standard when it comes to cancer trials—Pfizer and Astellas can help build Xtandi's case as the market leader in castration-resistant prostate cancer as the drug fends off challengers from Johnson & Johnson and Bayer.
Last month, Bayer and Orion's Nubeqa actually beat Xtandi to the punch with trial data showing it extended patients' lives over ADT alone in the nonmetastatic setting. Despite being last to the party with a July 2019 approval from the FDA, those results left Xtandi and J&J's Erleada scrambling to catch up.
Erleada, for its part, has made a run at matching OS data but has so far fallen short.
At the European Society for Medical Oncology annual meeting in September, J&J unveiled that its Erleada-ADT pairing cut patients’ risk of death by 25% compared with a combo of ADT plus placebo. However, at that second interim analysis, the benefit wasn’t enough to cross the statistical significance bar.