Economy

Xtandi/ADT combo extends survival in late-stage prostate cancer study

A phase 3 trial created to assess the addition of enzalutamide to androgen deprivation therapy for men with nonmetastatic castration-resistant prostate cancer met its primary endpoint of improved metastasis-free survival, according to the agents' manufacturers.

"We want to thank the patients, family members and clinicians who participated in the PROSPER trial and helped advance the scientific understanding of the potential role for Xtandi in this prevalent disease", Steven Benner, MD, senior vice president and global therapeutic area head for oncology development at Astellas, said in the release.

An approval to treat non-metastatic CRPC would significantly boost sales of Xtandi, which Pfizer got access to when it bought Medivation for $14 billion past year. And EvercoreISI's Umer Raffat for one is enthusiastic about what this could mean on the revenue side.

"Here's why this trial is so important", he wrote in a note to clients. "It increases the target market size by perhaps more than double".

Xtandi is now approved to treat castration-resistant prostate cancer that has spread to other parts of the body. Raffat estimates that in the US there's a pool of 20,000 patients with this form of prostate cancer in which it hasn't spread to other parts of the body.

Specifically, the Phase 3 trial was evaluating Xtandi plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic castration-resistant prostate cancer (CRPC). Xtandi met its goal of improving survival without allowing the cancer to spread.

Currently, Xtandi is approved for the treatment of metastatic CRPC based on clinical data from previous studies that showed a statistically significant overall survival benefit versus the placebo in a metastatic CRPC setting.



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