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Medivation, Astellas to start Phase III study of enzalutamide in non-metastatic prostate cancer
31 October 2014 - 31 October 2014 - US Medivation Inc (NASDAQ:MDVN) and Astellas Pharma US Inc, part of Japanese Astellas Pharma (TYO:4503), disclosed Thursday their plans to start a global Phase III study to assess the efficacy and safety of enzalutamide in patients with high-risk, hormone-sensitive, non-metastatic prostate cancer that has biochemically recurred (rising prostate-specific antigen [PSA] level) following definitive local therapy with radical prostatectomy and/or radiation therapy.

To date, there is no prescription medicine specifically approved in the USA for these patients.

The Phase III randomised, multi-national study will be carried out at about 160 sites and is designed to recruit around 1,860 hormone-sensitive, non-metastatic men with biochemical recurrence following prostatectomy and/or radiation therapy that are at high risk for morbidity and mortality from prostate cancer. Patients will be randomised into three separate groups - enzalutamide plus leuprolide acetate, enzalutamide monotherapy, or placebo plus leuprolide acetate. Treatment with enzalutamide monotherapy will be open-label. Treatment with enzalutamide and placebo will be double-blind in combination with open-label leuprolide acetate.

The study's primary objective is metastasis-free survival. The study will assess enzalutamide at a dose of 160 mg to be taken orally once a day. Leuprolide acetate will be administered as an injection of 22.5 mg once every 12 weeks for a minimum of three doses. All patients in the study will be treated for 37 weeks. Those achieving an undetectable PSA will suspend study drug(s). Should the PSA rise again, study drug(s) will be restarted. Study drug treatment will then continue until disease progression.

As Dr. Lynn Seely, chief medical officer of Medivation, explained, according to estimates, about one third of men in the USA experience a rising PSA, also known as biochemical recurrence, after localised therapy for the treatment of prostate cancer. The planned study will determine whether enzalutamide can delay the development of metastatic prostate cancer in high-risk men with a quickly rising PSA. Seely added. The start of this study in collaboration with Astellas serves as testament to the companies' mutual commitment to continue exploring the potential of enzalutamide in areas presenting significant unmet medical need, she noted.

Dr. Sef Kurstjens, chief medical officer of Astellas Pharma Inc. and president of Astellas Pharma Global Development, Inc, said that, following enzalutamide's continued favourable impact on overall survival and progression-free survival versus placebo in metastatic castration-resistant prostate cancer, the company is looking forward to continuing to explore the medicine's potential impact on patients at earlier stages of the disease.

Enzalutamide is an androgen receptor inhibitor acting on three different steps in the androgen receptor signalling pathway.
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