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Positive Survival Data from Interim Analysis of Phase III Trial of Prostate Cancer Drug



Thursday 3 November 2011



A new type of hormonal treatment has been shown to extend life for men with advanced prostate cancer, according to an interim 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 once-daily pill, known as 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.



The drug has been tested in 1,199 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy. 


Pharmaceutical companies Medivation and Astellas announced today that a planned interim analysis of the randomised, double-blind, placebo-controlled, multinational Phase III AFFIRM trial of MDV3100 had returned positive results.



Patients treated with MDV3100 lived an average 4.8 months longer than those given a placebo. The estimated median survival for men treated with MDV3100 was 18.4 months compared with 13.6 months for men treated with placebo.


As a result, the Independent Data Monitoring Committee recommended that the trial be stopped early and men who received the placebo be offered MDV3100.



"MDV3100 has a novel mechanism of action, inhibiting androgen receptor signaling at three distinct points in the signaling pathway,” said Professor de Bono, co-principal investigator of the AFFIRM study with Dr Howard I. Scher from Memorial Sloan-Kettering Cancer Center.  “So I am particularly pleased with the results of the AFFIRM interim analysis, as there is a real need for new treatments in advanced prostate cancer that target the cancer in different ways.”



Medivation and Astellas said today that they would pursue regulatory approval in the US, Europe and Japan for men who have already been treated with chemotherapy.



The drug is also being trialled in patients with earlier-stage disease. A Phase III trial is underway with 1,700 men with advanced prostate cancer who have not received chemotherapy. The drug is also in Phase II testing in nearly 400 men whose disease has progressed while on luteinizing hormone-releasing hormone (LHRH) analogue or hormone therapy, and in a separate Phase II study in hormone-naïve men.



Over recent years there has been a significant increase in the number of drugs available to treat 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-223 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 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

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


Johann de Bono
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