TRIP

Medivation prostate cancer drug well-tolerated in trial

Reuters Health News, 2012

Tue, Jan 31 2012 Tue, Jan 31 2012 Tue, Jan 31 2012 Mon, Jan 30 2012 Fri, Jan 27 2012
n">(Reuters) - Medivation Inc's experimental prostate cancer pill caused fewer serious side effects in clinical trial patients than a placebo treatment, according to full results from a pivotal study announced on Tuesday.
Medivation and partner Astellas Pharma Inc reported in November that the trial had been stopped early after it became clear that the drug, MDV3100, improved median overall survival by 4.8 months compared with a placebo.
Researchers said the trial of 1,199 patients with advanced prostate cancer showed that serious side effects occurred in 28.4 percent of MDV3100 patients, compared with 33.6 percent of the placebo group.
An earlier trial of MDV3100 found that 1.5 percent of 198 treated patients had seizures, and some observers were concerned about the drug's safety profile.
The results will likely position MDV3100 as the first treatment for use after patients have stopped responding to chemotherapy, according to Scher.
The safety profile of the drug "looked good with no major red flags," said ISI Group analyst Mark Schoenebaum, adding that the seizure rate "could pose some concern as the drug is developed in earlier stages of disease." The full trial results will be presented this week in San Francisco at a meeting sponsored by the American Society of Clinical Oncology.
Nicholas Vogelzang, an oncologist at the Comprehensive Cancer Centers of Nevada and chair of ASCO's communications committee, described the Medivation trial results as "unprecedented," adding "this is going to definitely change the way we take care of patients every day in the office." He was not involved in the study.
MDV3100 is one of a new class of drugs, known as androgen inhibitors, designed to interfere with the ability of testosterone to bind to prostate cancer cells.
Prostate cancer kills about 250,000 men a year globally and is the second most common cause of cancer death in men in the United States, after lung cancer.
IN TALKS OVER FDA SUBMISSION Other serious side effects from MDV3100 included fatigue, cardiac disorders, liver function test abnormalities and myocardial infarction, said Medivation Chief Executive David Hung, noting that all were more prevalent in the placebo group than in the treatment group.