Creating a free account will enable you to subscribe to our daily and weekly email newsletters, as well as customize your reading experience to show only the categories most relevant to you.
Signing up only take a few minutes, so why not give it a try and see what you've been missing out on.
Astellas Pharma Inc. and Medivation, Inc. have announced that the Independent Data Monitoring Committee (IDMC) has informed the companies of positive results from a planned interim analysis of the Phase 3 PREVAIL trial of XTANDI (enzalutamide) in more than 1,700 men with metastatic castration-resistant prostate cancer (mCRPC) that has progressed despite androgen deprivation therapy and who have not received chemotherapy[i]. Given the observed benefits in the trial's co-primary endpoints of overall survival and radiographic progression-free survival, and considering the observed safety profile, the IDMC concluded enzalutamide demonstrated a favorable benefit-risk ratio. The IDMC recommended the study be stopped and patients treated with placebo be offered enzalutamide. Additional data from the Phase 3 PREVAIL results, including safety data, will be submitted for presentation at an upcoming medical conference.
The IDMC informed the companies of the following results:[i]
Of the 1,715 patients treated in the blinded PREVAIL study, two patients were reported by investigators to have had a seizure event. The full analysis of the safety data will become available upon final database lock and unblinding.
Enzalutamide is a novel, oral, once-daily androgen receptor (AR) signaling inhibitor that inhibits multiple steps of the AR signaling pathway in three distinct ways: It blocks androgen binding to the androgen receptors, inhibits nuclear translocation of the AR complex and impairs association of the AR complex with DNA, thus impairing tumour cell replication and tumour growth.[ii]
"These are exciting times in the treatment of mCRPC and the discovery and development of enzalutamide represents a significant advance", said Professor Bertrand Tombal, MD, PhD, Chairman of the Division of the Urology, Cliniques Universitaires Saint Luc, Université Catholique de Louvain (UCL) and European Principal Investigator for PREVAIL. "The treatment options available to men with mCRPC have expanded significantly over the last few years, but the bottom line is that more than 70,000 men die each year from the disease. The registration of docetaxel was a major step towards cure but, 10 years later, we must acknowledge that many patients never received docetaxel, as indicated by recent Swedish data. These interim data for enzalutamide show us that its use before docetaxel induces a dramatic improvement in time to disease progression. These results demonstrate significant survival benefit in this setting, which are truly unprecedented and represent an important step forward in making this promising treatment available for men with advanced prostate cancer across Europe, following regulatory approval."
"We are very excited about these results and the potential to offer a new treatment option for patients with metastatic castration resistant prostate cancer, in the pre-chemotherapy setting," said Dr Mike Holmes, Senior Medical Director, Oncology, Astellas Pharma Europe Ltd. "There remains a high unmet patient need for a new treatment that offers patients with advanced prostate cancer, not only the opportunity to live for longer, but to do so with a good quality of life. We are committed to work with our partners, Medivation, to seek the necessary European regulatory approval for this expanded use of enzalutamide, based on the results of PREVAIL."
Medivation and Astellas will initiate meetings with and submission to regulatory agencies in 2014.
Enzalutamide is currently licensed in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy. [iii]
The Phase 3 PREVAIL trial is a randomised, double-blind, placebo-controlled, multi-national trial that enrolled over 1,700 patients at sites in the United States, Canada, Europe, Australia, Russia, Israel and Asian countries, including Japan. The trial enrolled patients with metastatic prostate cancer whose disease progressed despite treatment with androgen deprivation therapy and had not received chemotherapy. The co-primary endpoints of the trial are overall survival and radiographic progression-free survival. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily versus placebo. Targeted enrollment was completed in May 2012 and the interim analysis was pre-specified after approximately 516 death events.[iv]
XTANDI (enzalutamide) is a novel, oral, once-daily androgen receptor signaling inhibitor which works in three distinct ways: it inhibits testosterone binding to androgen receptors, nuclear translocation of androgen receptors; and DNA binding and activation by androgen receptors. In Europe, enzalutamide is currently licensed for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.
[i] Data on file: IDMC correspondence
[ii] Tran C, Ouk S, Clegg NJ et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science 2009; 324 (5928): 787–790
[iii] European Medicines Agency, Xtandi (enzalutamide) Summary of Product Characteristics, 2013
[iv] http://clinicaltrials.gov/ct2/show/NCT01212991 . Last accessed 21.10.13
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our Prostate / Prostate Cancer category page for the latest news on this subject.
Please use one of the following formats to cite this article in your essay, paper or report:
Astellas Pharma and Medivation. "Phase 3 trial of XTANDI™ in chemotherapy-naive patients meets both co-primary endpoints." Medical News Today. MediLexicon, Intl., 24 Oct. 2013. Web.
9 Dec. 2013. <http://www.medicalnewstoday.com/releases/267806>
Astellas Pharma and Medivation. (2013, October 24). "Phase 3 trial of XTANDI™ in chemotherapy-naive patients meets both co-primary endpoints." Medical News Today. Retrieved from
Please note: If no author information is provided, the source is cited instead.
If you write about specific medications, operations, or procedures please do not name healthcare professionals by name.
For any corrections of factual information, or to contact the our editorial team, please use our feedback form. Please send any medical news or health news press releases to:
Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.
This page was printed from: http://www.medicalnewstoday.com/releases/267806.php
Visit www.medicalnewstoday.com for medical news and health news headlines posted throughout the day, every day.
© 2004-2013 All rights reserved. MNT (logo) is the registered trade mark of MediLexicon International Limited.