Prostate cancer drug extends life after chemotherapy
pharmafile | March 29, 2012 | News story | Research and Development, Sales and Marketing | Astellas, Medivation, Zytiga, prostate cancer
Prostate cancer treatment MDV3100 has been shown to extend life by nearly five months in men with advanced disease who have been treated with chemotherapy.
The drug is being co-developed by Astellas and Medivation, and the encouraging phase III results suggest it will be a major new treatment for the disease.
Results from the trial were so encouraging that in November last year the Independent Data Monitoring Committee recommended that AFFIRM be stopped early, allowing men on the placebo arm to receive the treatment.
The drug is part of a wave of new treatments (drugs, radiotherapy, ultrasound and surgery) now emerging which will help extend survival in prostate cancer patients. Most notable among the new drug treatments is Janssen’s Zytiga (abiraterone), which was launched in the UK in September 2011.
MDV3100’s extended survival of nearly five months is very similar to the three and a half months median achieved by Zytiga in a similar trial.
But Astellas and Medivation say their drug has an advantage over Zytiga, in that it doesn’t need to be taken with the steroid prednisone, which can cause serious side effects of its own.
Results from the phase III AFFIRM study confirmed that MDV3100 showed a statistically significant improvement in overall survival with a median improvement over placebo of 4.8 months. The study also concluded that MDV3100 was generally well tolerated by patients and met all secondary endpoints.
“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.”
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.
“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,” said Dr Ian Banks, President of the European Men’s Health Forum.
He says that 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,” he concluded.
Medivation and Astellas signed their co-development deal in October 2009, and if approved, they will co-market MDV3100 in the US and Astellas will market MDV3100 outside the US.
MDV3100 is a novel, oral androgen receptor signalling inhibitor, and targets the androgen signalling pathway at three distinct points. It blocks testosterone binding to the androgen receptor, impairs movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibits binding to DNA. This has been shown to suppress cancer cell growth and induce cancer cell death (apoptosis).
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