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BRIEF-Pfizer, Astellas report positive top-line results from phase 3 PROSPER trial of XTANDI
September 14, 2017 / 9:13 AM / 3 months ago

BRIEF-Pfizer, Astellas report positive top-line results from phase 3 PROSPER trial of XTANDI

Sept 14 (Reuters) - Pfizer Inc:

* Pfizer and Astellas announce positive top-line results from phase 3 prosper trial of XTANDI (enzalutamide) in patients with non-metastatic castration-resistant prostate cancer

* Phase 3 prosper trial met its primary endpoint​

* Preliminary safety analysis of PROSPER trial appears consistent with safety profile of XTANDI in previous clinical trials​

* In study of patients taking XTANDI who earlier received docetaxel, 1% of XTANDI patients versus 0.3% of placebo patients died from infections or sepsis​

* In study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death​

* In placebo-controlled patients taking XTANDI who earlier got docetaxel, grade 3 or higher adverse reactions reported among 47% of XTANDI patients​

* In placebo-controlled study of chemotherapy-naïve patients, grade 3-4 adverse reactions were reported in 44% of XTANDI patients​

* In bicalutamide-controlled study of chemotherapy-naïve patients, grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients​

* Hypertension occurred in 11% of xtandi patients and 4% of placebo patients in two placebo-controlled trials​

* No patients experienced hypertensive crisis​ Source text for Eikon: Further company coverage:

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