Medivation's business is built on the identification and rapid development of product candidates that have the potential to improve the standard of care in human diseases.
Ongoing Clinical Studies
Enzalutamide
Medivation, in collaboration with Astellas, is currently developing enzalutamide for multiple stages of prostate cancer and for breast cancer.
Prostate Cancer
Enzalutamide in Pre-Chemotherapy Castration Resistant Prostate Cancer (CRPC)
We, together with our collaboration partner Astellas, have several ongoing clinical trials to evaluate the safety and efficacy of enzalutamide in pre-chemotherapy CRPC patients, including both metastatic and non-metastatic disease. The largest such trial is our ongoing PREVAIL trial, a randomized, double-blind, placebo-controlled Phase 3 trial, evaluating enzalutamide (160 mg once daily) as compared to placebo in approximately 1,700 patients with pre-chemotherapy mCRPC. PREVAIL includes patients who have progressed following treatment with an LHRH analog drug only, as well as patients who have progressed following treatment with both an LHRH analog drug and an anti-androgen drug. The co-primary endpoints are radiographic progression-free survival and overall survival. We completed enrollment in the PREVAIL trial in May 2012. The planned interim analysis for the PREVAIL trial is expected to occur in 2013.
We and Astellas are also conducting the TERRAIN trial and the STRIVE trial, two randomized, double-blind Phase 2 trials evaluating enzalutamide head-to-head versus bicalutamide, the leading marketed anti-androgen drug, in pre-chemotherapy CRPC patients. The TERRAIN trial, which began in March 2011, is enrolling approximately 370 men, and the STRIVE trial, which began in August 2012, is enrolling approximately 400 men. The primary endpoint in both studies is progression-free survival. The primary differences between the trials are that TERRAIN is enrolling only metastatic patients while STRIVE is enrolling both metastatic and non-metastatic patients, and TERRAIN is being conducted primarily in Europe while STRIVE is being conducted primarily in the United States.
In May 2012, we initiated patient enrollment in an open-label clinical trial evaluating enzalutamide, either in combination with leuprolide and dutasteride or alone, as neoadjuvant therapy in approximately 50 men who have been diagnosed with prostate cancer but not yet undergone prostatectomy. Men in this trial will receive enzalutamide for six months before prostatectomy, and then undergo surgery. The removed prostates will then be examined pathologically to determine whether any cancer remains. The primary endpoint in this trial is pathologic complete response rate.
Enzalutamide in Breast Cancer
In April 2012, we and Astellas expanded the clinical development of enzalutamide to include a new indication, breast cancer. We are enrolling patients in an open label Phase 1 study designed to evaluate the safety and tolerability of enzalutamide in approximately 60 metastatic breast cancer patients who have failed at least two prior hormonal therapies.
For more information about our clinical studies, please contact Medivation at trials@medivation.com
To learn more about clinical trials, please visit www.clinicaltrials.gov, a service of the U.S. National Institutes of Health.
Completed Enzalutamide Studies
AFFIRM
In November 2010 we completed enrollment in a randomized, double-blind, placebo-controlled, Phase 3 trial evaluating enzalutamide (formerly MDV3100) (160 mg/day) versus placebo in 1,199 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy. Data from this trial were published in The New England Journal of Medicine in 2012.
Phase 1-2 Trial
In December 2008, we completed enrollment in an open-label Phase 1-2 clinical trial of enzalutamide in patients with metastatic castration-resistant prostate cancer. We enrolled 140 patients in seven dose groups, ranging from 30 mg/day to 600 mg/day. Of the 140 patients, 75 had previously failed docetaxel-based chemotherapy and 65 were chemotherapy-naïve. All 140 patients also had failed at least one line of prior hormonal therapy. The trial endpoints included safety, tolerability, pharmacokinetics, circulating tumor cell, or CTC, counts, PSA levels, radiographic change in soft tissue and bony metastases, and time to progression. Data from this trial were published in The Lancet in 2010.
Hormone-Naïve
In January 2012, we completed enrollment in an open label Phase 1-2 clinical trial of enzalutamide in hormone-naïve patients. The study enrolled 67 patients, and was the first time we had dosed enzalutamide in men who had not yet undergone prior hormone therapy. Data from this trial were reported at the 2013 Genitourinary Cancers Symposium in February.