Medivation, Inc. (MDVN - Analyst Report) and partner Astellas Pharma Inc. announced positive survival data on their phase III prostate cancer candidate, MDV3100. Medivation and Astellas said that results from a planned interim analysis showed a statistically significant improvement in overall survival compared to placebo. The interim analysis was conducted at 520 events.
The phase III randomized, double-blind, placebo-controlled study, AFFIRM, was conducted in men with advanced prostate cancer previously treated with docetaxel-based chemotherapy.
The interim data is impressive with MDV3100 showing a 4.8-month advantage in median overall survival compared to placebo (18.4 months versus 13.6 months). A 37% reduction in risk of death was observed in the MDV3100 arm compared to placebo.
Based on the positive interim data, the Independent Data Monitoring Committee (IDMC) recommended that AFFIRM should be stopped early and patients in the placebo arm should be offered MDV3100. The IDMC said that MDV3100's risk-to-benefit ratio was favorable enough to stop the study.
A full analysis of the results including safety data will be presented at an upcoming scientific meeting.
Medivation and Astellas intend to conduct a pre-NDA meeting with the FDA early next year. We expect to gain more visibility on the regulatory path for the candidate on the conclusion of this meeting.
In addition to the AFFIRM study, MDV3100 is currently in another phase III study, PREVAIL, which is being conducted in men with advanced prostate cancer who have not received chemotherapy. Two phase II studies are also in progress. While one study, TERRAIN, is being conducted in men whose disease has progressed while on luteinizing hormone releasing hormone (LHRH) analogue or hormone therapy, the other phase II study is being conducted in hormone-naïve men.
Outperform on Medivation
We have an Outperform recommendation on Medivation, which carries a Zacks #1 Rank (short-term Strong Buy rating). Medivation shares received a major boost on the positive MDV3100 data. Based on the data that we have seen so far, we believe MDV3100 has blockbuster potential.