An experimental prostate cancer drug, MDV 3100, by Medivation Inc. and Astellas Pharma Inc. caused fewer serious side effects in the patients of clinical trials than patients taking placebo as reported by pivotal study on Tuesday.
“MDV3100 outperformed our expectations in the AFFIRM trial by meeting the primary and secondary endpoints with strong statistical significance and demonstrating a favorable safety profile,” said Howard I. Scher, M.D., chief, Genitourinary Oncology Service at Memorial-Sloan Kettering Cancer Center, and the co-principal investigator of the AFFIRM study. “These results, together with its convenient once-daily oral dosing regimen, should make MDV3100 a promising option for men with prostate cancer who have received prior hormones and chemotherapy.”
According to the reports, men taking the drug survived for a median of 18.4 months as compared to the men taking placebo, who have a median-life of 13.6 months.
Common side effects of the drug were fatigue, hot flush and diarrhea.
“The almost five-month overall survival benefit MDV3100 showed over placebo in this trial is noteworthy, as is the fact that men with post-chemotherapy prostate cancer taking MDV3100 lived for a median of a year and a half,” said Professor Johann de Bono, M.D., MSc, Ph.D., FRCP, Honorary Consultant in Medical Oncology, Professor of Experimental Cancer Medicine, The Institute of Cancer Research and The Royal Marsden Hospital, and the co-principal investigator of the AFFIRM study. “As a practicing oncologist, I am hopeful that I may be able to offer MDV3100 as a life-prolonging option to these very ill patients.”
The results will be presented in the presentation at the upcoming 2012 Genitourinary Cancers Symposium in San Francisco, CA on Thursday, February 2.