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news.Medivation and Astellas Pharma have announced positive results from the Phase III AFFIRM trial of the investigational drug MDV3100 in men with prostate cancer previously treated with chemotherapy.
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According to the study, men taking MDV3100 lived for a median of 18.4 months, compared with 13.6 months for men taking placebo (p < 0.0001; HR=0.631).
The investigational agent also met all secondary endpoints, including radiographic progression-free survival, soft tissue response rate and time to prostate-specific antigen progression.
MDV3100 was well tolerated and common side effects included fatigue, diarrhea and hot flush.
Medivation president and CEO said David Hung said the overall survival data produced by MDV3100 clinically validate the mechanism of action in treating men with prostate cancer who received prior chemotherapy.
Astellas Pharma Global Development president Steven Ryder said that MDV3100 is a significant contributor to their strategy of becoming a global category leader in oncology.