Saturday 2 June 2012
An investigational drug has been shown to extend life for men with advanced prostate cancer and offers improved quality of life, according to new data from a Phase III clinical trial jointly led by The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust.
Professor Johann de Bono from the ICR and The Royal Marsden will present trial results for the new type of hormone treatment called enzalutamide (formerly MDV3100), at the ASCO annual meeting today.
Professor de Bono said: “The trial showed that enzalutamide was not only keeping men alive for longer, but for some it was also improving their quality of life. Some patients had been reporting significant pain and so this result is very pleasing. The success of this trial could give doctors a valuable new treatment option, which is sorely needed as men with advanced prostate cancer have few therapies available to them.”
Around 43 per cent of men taking enzalutamide as part of the AFFIRM trial reported an improved quality of life, compared to 18 per cent of men taking a placebo. To assess quality of life, trial subjects took a FACT-P assessment that considers 27 measures including level of energy, ability to cope with their illness, level of pain, ability to work and amount of support needed from family and friends. Patients were defined as having an increased quality of life if their score increased by 10 per cent or more. Professor de Bono said that the trial also showed that enzalutamide was well tolerated by patients, with no serious side-effects.
Patients taking enzalutamide as part of the AFFIRM trial lived an average of 18.4 months compared to 13.6 months for patients taking a placebo. The trial also provided positive results on all other measures of effectiveness, known as secondary endpoints.
The multinational, randomised placebo-controlled AFFIRM trial, sponsored by pharmaceutical companies Medivation and Astellas, included 1,199 men with metastatic castration-resistant prostate cancer that had stopped responding to chemotherapy.
Enzalutamide is the first in a new class of medicines called androgen receptor signaling inhibitors. Prostate cancer relies on testosterone to grow, so this drug has been designed to bind to the receptors on prostate cancer cells that normally interact with testosterone, and block this interaction.
In November last year, the trial’s Independent Data Monitoring Committee recommended that the trial be stopped early and men who received the placebo be offered enzalutamide.
Medivation and Astellas announced they had submitted of a New Drug Application for enzalutamide to the US FDA on May 21, 2012. Medivation and Astellas are also preparing to submit for regulatory approval in Europe and Japan.
Over recent years there has been a significant increase in the number of drugs shown to benefit men with advanced prostate cancer. The ICR and The Royal Marsden have played a role in developing four of the six drugs that have been shown in Phase III testing to extend life for these men, including abiraterone acetate (Zytiga®), radium-233 chloride (Alpharadin®), cabazitaxel (Jevtana®) and now enzalutamide. The other two drugs are docetaxel (Taxotere®) and sipuleucel-T (Provenge®).
Media Contact: ICR Science Communications Manager Jane Bunce on 0207 153 5106 or after hours Tatjana Trposka on 07780689891
Notes to editors:
Enzalutamide is not currently commercially available in the UK.
The ASCO abstract can be found here
The Institute of Cancer Research (ICR) is one of the world’s most influential cancer research institutes.
Scientists and clinicians at the ICR are working every day to make a real impact on cancer patients’ lives. Through its unique partnership with The Royal Marsden Hospital and ‘bench-to-bedside’ approach, the ICR is able to create and deliver results in a way that other institutions cannot. Together the two organisations are rated in the top four cancer centres globally.
The ICR has an outstanding record of achievement dating back more than 100 years. It provided the first convincing evidence that DNA damage is the basic cause of cancer, laying the foundation for the now universally accepted idea that cancer is a genetic disease. Today it leads the world at isolating cancer-related genes and discovering new targeted drugs for personalised cancer treatment.
As a college of the University of London, the ICR provides postgraduate higher education of international distinction. It has charitable status and relies on support from partner organisations, charities and the general public.
The ICR’s mission is to make the discoveries that defeat cancer. For more information visit www.icr.ac.uk
The Royal Marsden NHS Foundation Trust
The Royal Marsden opened its doors in 1851 as the world’s first hospital dedicated to cancer diagnosis, treatment, research and education.
Today, together with its academic partner, The Institute of Cancer Research (ICR), it is the largest and most comprehensive cancer centre in Europe treating over 44,000 patients every year. It is a centre of excellence with an international reputation for groundbreaking research and pioneering the very latest in cancer treatments and technologies. The Royal Marsden also provides community services in the London boroughs of Sutton and Merton and in June 2010, along with the ICR, the Trust launched a new academic partnership with Mount Vernon Cancer Centre in Middlesex.
Since 2004, the hospital’s charity, The Royal Marsden Cancer Charity, has helped raise over £50 million to build theatres, diagnostic centres, and drug development units.
Prince William became President of The Royal Marsden in 2007, following a long royal connection with the hospital.
For more information, visit www.royalmarsden.nhs.uk