Medivation
Inc. is poised to jump into the crowded post-chemotherapy prostate
cancer market. Where the androgen receptor inhibitor fits in, particularly with
Johnson
& Johnson's Zytiga abiraterone, will depend on forthcoming safety
data as well as results from studies in earlier-stage patients.
An independent DMC recommended
stopping the company's Phase III AFFIRM trial in 1,199 patients with metastatic
castration-resistant prostate cancer (CRPC) after interim data showed
once-daily MDV3100 met the primary endpoint by improving median overall
survival (OS) vs. placebo by 4.8 months (18.4 vs. 13.6 months; HR=0.63;
p<0.0001).