The interview with Dr Charles Sawyers from Memorial-Sloan Kettering recently, talking about his role in Medivation’s MDV3100, turned out to be rather good timing. On Friday, Medivation announced their 1Q earnings and clinical progress.
The big news is that aside from the ongoing phase III trials in castrate-resistant prostrate cancer (CRPC) before (PREVAIL) and after failure of docetaxel (AFFIRM), the company are seeking to explore the use of MDV3100 earlier in the disease. This makes a lot of sense, both clinically and strategically. A phase II trial is already open in the pre-chemotherapy setting, comparing MDV3100 to bicalutamide (TERRAIN).
- The first phase II trial evaluates the combination of MDV3100 with bicalutamide in the treatment of advanced prostate cancer patients who have progressed while on LHRH analogue therapy or following surgical castration. TERRAIN is expected to enroll approximately 370 patients in North America and Europe. The primary endpoint of the trial is progression-free survival. This trial is ongoing and patients are enrolling.