Astellas and Medivation see strong Ph I/II data on prostate cancer drug candidate MDV3100

US firm Medivation and Japan's Astellas Pharma, with which it entered into a $765 million licensing deal last fall, have announced the publication of positive results from their previously reported Phase I/II trial of the novel triple-acting oral androgen receptor antagonist MDV3100 in men with progressive, metastatic castration-resistant prostate cancer in the April 15 on-line version of The Lancet.

According to the published results, MDV3100 demonstrated anti-tumor activity in patients with late-stage prostate cancer as evaluated by reductions in prostate specific antigen (PSA) levels, radiographic findings and circulating tumor cell (CTC) counts. Anti-tumor effects were observed in patients who were resistant to standard anti-androgen treatments, as well as in patients who had progressed following chemotherapy. MDV3100 is currently in Phase 3 development for the treatment of advanced prostate cancer.

'MDV3100, with its unique mechanism of action, could offer an important new treatment option to men with prostate cancer that is resistant to currently available anti-androgens,' said Howard Scher, lead author of The Lancet article and chief of the Genitourinary Oncology Service at Memorial Sloan-Kettering Cancer Center in New York. 'It is particularly encouraging that antitumor activity was seen on all outcomes assessed in patients who had failed chemotherapy because their survival times are one year or less, on average, and their treatment options are limited.'