Trial confirms benefit of 'exciting' new drug for advanced prostate cancer
Results of an international clinical trial have confirmed the benefits of enzalutamide, a new treatment for advanced prostate cancer.
The drug, formerly known as MDV3100 - which has yet to be licensed in the US or Europe - improved survival rates for men with advanced, previously treated prostate cancer by five months, compared with men who took a placebo.
The drug is the fourth new prostate cancer drug to emerge from research labs worldwide, following on from cabazitaxel, a new chemotherapy drug, alpharadin, a radiopharmaceutical (neither of which is yet available on the NHS), and abiraterone, which was recently given the green light by drug regulators across the UK.
Like abiraterone, enzalutamide exploits the fact that prostate cancers are encouraged to grow by male sex hormones - known as androgens.
While abiraterone attempts to block the body's production of androgens, a different approach has been taken with enzalutamide.
The drug disrupts the function of molecules found within cells, called androgen receptors, which help to transmit messages from androgens that tell cells to divide and grow.
The results published today in the New England Journal of Medicine are the full details of initial data presented at the American Society of Clinical Oncology's annual conference in June.
In a phase III trial, nearly 1,200 men with advanced metastatic castration-resistant prostate cancer were given either enzalutamide or a placebo (dummy pill).
After two years of follow-up, those who only took a placebo survived for an average of 13.6 months, while those undergoing the enzalutamide treatment survived for 18.4 months.
But while the drug has been tested on those with advanced stages of prostate cancer who have already had chemotherapy, it hasn't yet been tested in men with less advanced forms of the disease.
The makers of enzalutamide have now applied for a licence to sell the drug in the US, and are planning to apply for a European license.
Professor Nick James, Cancer Research UK's prostate cancer expert at the University of Birmingham, said the results were part of a "real sea-change" in prostate cancer treatment.
"There's every reason to think that the outlook for patients in a few years's time will be much brighter than in the past. Enzalutamide targets a pathway inside prostate cancer cells that was discovered as a result of over a decade of painstaking laboratory and clinical science.
"It's highly likely that combining enzalutamide with other new treatments like abiraterone and cabazitaxel - either simultaneously or in sequence - will transform things for prostate cancer patients in the way drugs like tamoxifen and Herceptin have started to turn the tide in breast cancer.
"But we still need to find out exactly how best to use all these exciting new treatments, in what order, and who best to give them to through more research and more trials."
Copyright Press Association 2012
- Scher, H.I., Fizazi, K., Saad, F., Taplin, M.E., Sternberg, C.N., Miller, M.D.K., de Wit, R., Mulders, P., Chi, K.N., Shore, N.D. & (2012). Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy, New England Journal of Medicine, DOI: 10.1056/NEJMoa1207506