Prostate cancer drug shows impressive new Phase III trial results
Wednesday 1 February 2012
Patients with advanced prostate cancer who were given a new type of hormonal treatment called MDV3100 lived an extra 4.8 months compared to men taking a placebo, according to the full analysis of a Phase III trial jointly led by Professor Johann de Bono from The Institute of Cancer Research (ICR) and The Royal Marsden Hospital.
The new results from the AFFIRM trial of the once-daily pill will be presented in a late-breaking oral presentation at the upcoming 2012 Genitourinary Cancers Symposium in San Francisco on Thursday February 2.
The multinational, randomized placebo-controlled trial, sponsored by pharmaceutical companies Medivation and Astellas, included 1,999 men with advanced prostate cancer who had all previously received docetaxel-based chemotherapy.
In the final analysis of survival data, men taking MDV3100 lived for a median of 18.4 months compared with 13.6 months for men taking placebo. The drug also returned positive results on all other measures of effectiveness, known as secondary endpoints. When compared to the placebo group, more patients taking MDV3100 experienced a drop of at least 50 per cent in their prostate specific antigen (PSA) levels (54 per cent versus one per cent), and had more time before their PSA level started to rise (8.3 months versus 3.0 months). X-rays showed mean time until tumour growth among the treatment group was also longer (8.3 months versus 2.9 months).
Professor de Bono said MDV3100 was also well tolerated by patients, with no serious side-effects.
“The almost five-month overall survival benefit MDV3100 showed over placebo in this trial is noteworthy, as is the fact that men with post-chemotherapy prostate cancer taking MDV3100 lived for a median of a year and a half,” said study co-investigator Professor de Bono. “As a practicing oncologist, I am hopeful that I may be able to offer MDV3100 as a life-prolonging option to these very ill patients.”
MDV3100 is the first in a new class of medicines called androgen receptor signaling inhibitors (ARSI). 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 MDV3100. Medivation and Astellas are pursuing regulatory approval in Europe, Japan and the US – where the FDA has granted a Fast Track designation – for the drug to be licensed for men who have already tried chemotherapy. MDV3100 is also being trialled in patients with earlier-stage disease.
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 MDV3100. 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 077217 47900
Notes to editors:
The results will be presented at ASCO’s Genitourinary Cancers Symposium on February 2 at 10.15am by study co-principal investigator Howard I. Scher, M.D., chief, Genitourinary Oncology Service at Memorial-Sloan Kettering Cancer Center.
The Institute of Cancer Research (ICR)
- The ICR is Europe’s leading cancer research centre
- The ICR has been ranked the UK’s top academic research centre, based on the results of the Higher Education Funding Council’s Research Assessment Exercise
- The ICR works closely with partner The Royal Marsden NHS Foundation Trust to ensure patients immediately benefit from new research. Together the two organisations form the largest comprehensive cancer centre in Europe
- The ICR has charitable status and relies on voluntary income
- As a college of the University of London, the ICR also provides postgraduate higher education of international distinction
- Over its 100-year history, the ICR’s achievements include identifying the potential link between smoking and lung cancer which was subsequently confirmed, discovering that DNA damage is the basic cause of cancer and isolating more cancer-related genes than any other organisation in the world
- The ICR is home to the world’s leading academic cancer drug development team. Several important anti-cancer drugs used worldwide were synthesised at the ICR and it has discovered an average of two preclinical candidates each year over the past five years.
- The Institute of Cancer Research’s Clinical Trials and Statistics Unit (ICR-CTSU) is an academic clinical trials unit accredited by the National Cancer Research Institute (NCRI) to conduct clinical trials into cancer treatments. The department is funded by an infrastructure grant from Cancer Research UK.
For more information visit www.icr.ac.uk
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