Abiraterone: an ICR success story
Abiraterone is a drug discovered at The Institute of Cancer Research (ICR) which has been shown in clinical trials to extend life for men with late-stage prostate cancer.
Following more than two decades of dedicated work, in 2011 the drug was approved in the US and Europe for men with metastatic advanced prostate cancer.
ICR scientists discuss the discovery and development of new prostate cancer drug abiraterone. Video with thanks to the Prostate Cancer Foundation.
Prostate cancer relies on testosterone to grow, so one of the main ways doctors treat the disease is by blocking this male hormone. Over time most patients’ cancers stop responding to standard hormone treatments and many scientists believed that the cancers had learned how to grow without testosterone. In the 1990s, scientists at the ICR began investigating a new theory that these prostate cancers were using testosterone from elsewhere in body to grow. Read more
An interim analysis of a Phase III trial showed abiraterone acetate was effective in patients who had not been treated with chemotherapy. The large-scale international trial was stopped early to allow those on the placebo arm to be offered the drug. The drug is already licensed for patients who have tried chemotherapy, but the latest trial tested the drug in patients with metastatic castration-resistant prostate cancer who had mild or no symptoms and had not been treated with chemotherapy. Read more
The once-daily pill has officially launched in the UK. The ICR's Chief Executive Professor Alan Ashworth FRS said the British licence was "the culmination of immense hard work and dedication by scientists and clinicians here and around the world. To have reached the point where thousands of prostate cancer patients will be able to benefit from this life-extending treatment is hugely rewarding." Read more
In September 2011, abiraterone was approved for use throughout Europe to treat metastatic “castration-resistant” prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. The ICR’s Chief Executive Professor Alan Ashworth said the approval was great news for the 90,000 men who succumb to prostate cancer in Europe each year. Read more
In July 2011, the European medicines regulator assessed the scientific evidence supporting the use of abiraterone and gave a positive opinion that it should be available throughout the EU. They recommended it for men with metastatic castration-resistant prostate cancer who were no longer responding to standard hormone therapy or a docetaxel-based chemotherapy regimen. The decision was then referred to the European Commission for sign-off. Read more
The Phase III trial results were peer-reviewed and published in the New England Journal of Medicine in May 2011. Further analysis of the trial data confirmed that a much greater number of patients taking abiraterone acetate than the placebo experienced a reduction in pain.
Professor Alan Ashworth commented that the success of the study had confirmed that men with advanced prostate cancer could still benefit from treatments targeting male hormones, correcting 40 years of misunderstanding about this disease.
In April 2011, The US Food and Drug Administration approved abiraterone for use in men with advanced metastatic prostate cancer in combination with the steroid prednisone. The decision was largely based on data from the Phase III clinical trial jointly led by the ICR and The Royal Marsden. Read more
The Phase III trial of abiraterone, involving almost 1,200 men across 13 countries, confirmed it could extend life for men with advanced metastatic prostate cancer who had run out of other treatment options. Men who were given the drug in combination with the steroid prednisone lived an average of 14.8 months compared with 10.9 months for men given a placebo. The data were so compelling that at an interim assessment, all men on the placebo arm were offered the drug. Read more
A second Phase II study trialled abiraterone in men who were no longer responding to any of the standard treatments, including old-style hormone therapy and the chemotherapy drug docetaxel. Abiraterone shrank or stablised men’s cancers for an average of almost six months, which Professor Johann de Bono from the ICR and the Royal Marsden, described as ‘very impressive’. Read more
The Phase I/II study – also led by the ICR and The Royal Marsden NHS Foundation Trust – confirmed the promising initial results, with the drug benefiting around two-thirds of the 54 men with advanced prostate cancer on the trial. ICR scientists also worked out how to delay the onset of resistance to the drug and developed a test to identify those men who were most likely to respond to abiraterone. Read more
Professor Johann de Bono led the Phase I clinical trial of abiraterone, the results of which generated considerable excitement when they published in July 2008.
Although the trial was designed primarily to assess the safety of the drug, the investigators found that tumours shrank and PSA levels fell dramatically for the majority of the 21 men who received the drug. Patients also reported an improvement in quality of life.
Robin Hood, then 65, reported that his health improved within a week of starting the drug trial, allowing him to take part in a tough sailing race. Read more