Astellas Pharma Europe Ltd. (APEL) has announced that data presented at the European Association of Urology (EAU) congress in Paris, France, have shown that the investigational drug MDV3100  extended life by nearly 5 months, compared to placebo, in men with advanced prostate cancer, previously treated with chemotherapy.

MDV3100, developed by Astellas Pharma Inc. and Medivation Inc., is a novel, oral androgen-receptor signalling inhibitor in clinical development for advanced prostate cancer. 

Results from the phase III AFFIRM study confirmed that MDV3100 demonstrated a statistically significant improvement (p

“Extending patients’ lives at this late stage of their disease is our primary aim, but it’s incredibly important to balance this with the impact treatment may have on patient quality of life,” said Professor Axel Heidenreich, Chairman and Director of the Department of Urology, Rheinisch-Westfälische Technische Hochschule (RWTH) University, Aachen, Germany.

“These data are encouraging and indicate that as well as extending the time until their disease progresses and providing a significant survival benefit, this is achieved without significant impact on the patient due to side effects.”

Secondary endpoints in the study included radiographic progression-free survival (rPFS) and time to prostate-specific antigen (PSA) progression. A median rPFS of 8.3 months was seen in the MDV3100 group compared to 2.9 months for placebo [HR = 0.404].

There was a statistically significant (p<0.0001) in overall survival with a median improvement over placebo of 4.8 months [hazard ratio (HR) = 0.631]. The study also concluded that MDV3100 was generally well tolerated by patients with the majority of adverse events (type and frequency) being comparable to placebo. 

Common side effects included fatigue, diarrhoea and hot flushes.  Adverse events of interest included fatigue (6.3% in the MDV3100 group versus 7.3% in the placebo group), cardiac disorders (0.9% versus 2.0%) including myocardial infarction (0.3% versus 0.5%), seizure (0.6% versus 0.0%) and liver function test abnormalities (0.4% versus 0.8%).¹

“Around 2.6 million cases of prostate cancer are diagnosed in Europe each year and around 40% of men go on to develop advanced prostate cancer, where the cancer has spread outside the prostate. Although there have been significant advances in the treatment of advanced prostate cancer recently, there are still relatively few options available for these men. Yes, men at this stage of their disease are looking for treatments to keep them alive for longer, but they also want to be able to live their lives as fully as possible. Therefore new advances that may be able to deliver this are very welcome,” said Dr Ian Banks, President of the European Men’s Health Forum.

The results have notably yet to be peer-reviewed and published: Results from the AFFIRM study will be submitted for publication in an appropriate medical journal during 2012.

Source: Astellas Pharma Europe Ltd.