Abiraterone acetate shows success in earlier-stage prostate cancer patients
Saturday 2 June 2012
A large-scale international trial has shown that the drug abiraterone acetate can benefit patients with earlier-stage prostate cancer, according to results being presented at the ASCO annual meeting today.
The National Institute of Clinical Excellence (NICE) recently recommended abirareone acetate for NHS patients with advanced prostate cancer who had already been treated with chemotherapy. This study represents the first time a survival benefit has been shown in patients who have not tried chemotherapy.
Abiraterone acetate was discovered at The Institute of Cancer Research (ICR) in what is now the Cancer Research UK Cancer Therapeutics Unit, and further developed by the ICR and The Royal Marsden Hospital*. Professor Johann de Bono from the ICR and The Royal Marsden was lead investigator on the pivotal Phase III clinical trial that led to NICE’s decision.
Professor de Bono, a co-investigator on the latest trial, said: “Many thousands of patients around the world are already living longer thanks to abiraterone acetate, and the success of this trial may mean that men with earlier stage cancer could benefit too.”
“Abiraterone acetate is already available in the US and Europe for men with advanced prostate cancer who have been treated with chemotherapy. These initial trial results are very promising and ultimately could lead to abiraterone acetate being made available for men with earlier stage cancer. This could allow men to delay the use of cytotoxic chemotherapy in favour of treatment with abiraterone, which has minimal and easily-manageable side-effects.”
The randomised, placebo-controlled, Phase III trial demonstrated that abiraterone acetate plus the steroid prednisone blocked tumour growth for significantly longer than a placebo. Scans could detect tumour growth after an average of 8.3 months for men in the placebo group, while for men in the abiraterone group an average figure was not yet available as, at the pre-specified interim analysis, growth was still halted for many men.
There were also strong indications that the drug, marketed as Zytiga by Janssen, increased overall survival. Men in the placebo group lived an average of 27.2 months but many patients treated with abiraterone were still alive at a pre-specified interim analysis, and so a statistically significant average survival figure was not available.
All 1,088 patients in the trial had metastatic castration-resistant prostate cancer, mild or no symptoms and had not been treated with chemotherapy. The drug returned positive results on all other measures of effectiveness, known as secondary endpoints, including the amount of time until men began using opiates for cancer pain. Men taking abiraterone were able to delay treatment with cytotoxic chemotherapy for 25.2 months, compared to 16.8 months for men in the placebo group. It also continued to show minimal side-effects.
The trial was stopped early due its effectiveness, so those on the placebo arm could be offered the drug.
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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Media Contact: ICR Science Communications Manager Jane Bunce on 0207 153 5106 or after hours Tatjana Trposka on 07780689891
Dr Charles J. Ryan from the UCSF Helen Diller Family Comprehensive Cancer Center is lead author of ASCO abstract LBA 4518 and will present the COU-AA-302 trial results.
* 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.
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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.