Wednesday 14 March 2012
A large-scale international trial of abiraterone acetate in patients with earlier-stage prostate cancer has been stopped early due its effectiveness, so those on the placebo arm could be offered the drug.
Abiraterone acetate, which was discovered at The Institute of Cancer Research*, is already licensed for use in Europe and the US for patients with advanced prostate cancer who have tried chemotherapy.
The new Phase III study tested abiraterone acetate, marketed as Zytiga by Janssen, in metastatic castration-resistant prostate cancer patients who had mild or no symptoms and had not been treated with chemotherapy.
An interim analysis showed that patients taking abiraterone lived longer than patients on the placebo, and scans showed their cancer’s growth was halted for longer. The drug also returned positive results on other measures of effectiveness, known as secondary endpoints, and continued to show favourable side-effects in combination with the steroids prednisone or prednisolone.
An independent data monitoring committee assessed that the drug showed clinical benefit and unanimously recommended that the trial be unblinded so all 1,088 participants could receive the drug, according to an announcement by Janssen.
Abiraterone aceate was discovered in the ICR’s Cancer Research UK Cancer Therapeutics Unit. A Phase III trial in patients who had previously tried chemotherapy, which was led in the UK by Professor Johann de Bono from the ICR and The Royal Marsden, showed that patients given abiraterone acetate lived on average 15.8 months compared to 11.2 months for men taking a placebo. Pain also eased for a higher proportion of patients taking abiraterone, while side-effects were easily manageable and reversible.
The new results will be presented at an upcoming medical meeting and will also be submitted for publication in a peer-reviewed journal.
Janssen has announced that it plans to apply to the regulators in the second half of 2012 to extend abiraterone’s license to cover men who have not received chemotherapy. If approved, this could significantly increase the number of patients receiving the drug.
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* Abiraterone was discovered at the ICR in research supported by grants from Cancer Research Campaign (now Cancer Research UK), the Medical Research Council (MRC) and BTG International LTD. Subsequent patient trials and further research on abiraterone was supported by Cougar Biotechnology Inc. / Janssen Pharmaceutical Companies, Cancer Research UK, Experimental Cancer Medicine Centre, the MRC, BTG International Ltd, Prostate Cancer Foundation, Prostate Cancer Research Foundation, Prostate Cancer Charity, the ICR and The Royal Marsden. Cancer Research Technology assigned abiraterone acetate to BTG International Ltd, who in turn licensed it to Cougar Biotechnology Inc., now a member of the Janssen Pharmaceutical Companies.
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.