Medivation And Astellas' Prostate Cancer Drug To Enter Phase 3 Trial For New Indication
By C. Rajan, contributing writer
Medivation and Astellas have announced they will be moving their jointly developed prostate cancer drug, enzalutamide, into a new Phase 3 clinical trial for high-risk, hormone-sensitive, non-metastatic prostate cancer that has biochemically recurred after local therapy. There is no approved medicine for this indication in the U.S. to date.
The randomized, global Phase 3 trial will evaluate the safety and efficacy of enzalutamide in approximately 1,860 hormone-sensitive, non-metastatic men with rising prostate-specific antigen (PSA) levels, following prostatectomy and/or radiation therapy. The study will evaluate the patients in three randomized groups receiving: enzalutamide plus leuprolide acetate, enzalutamide monotherapy, or placebo plus leuprolide acetate. The primary endpoint of the trial will be metastasis-free survival.
"It is estimated that approximately one third of men in the United States experience a rising PSA, also known as biochemical recurrence, after localized therapy for the treatment of prostate cancer," said Lynn Seely, M.D., CMO of Medivation. "This trial will determine if enzalutamide can delay the development of metastatic prostate cancer in high-risk men with a rapidly rising PSA. The initiation of this trial in collaboration with our partner Astellas showcases our mutual commitment to continue exploring the potential of enzalutamide in areas of significant unmet medical need."
Xtandi (enzalutamide) has already been approved by the FDA in 2012 for metastatic castration-resistant prostate cancer (CRPC) in patients who have previously received chemotherapy. This September, Xtandi was approved for a new indication in patients with metastatic CRPC who have not received chemotherapy.
In the previous clinical trials for its other indications, enzalutamide has improved overall survival and progression-free survival in metastatic CRPC. With this new Phase 3 study, the companies are hoping to evaluate the drug’s impact on patients in earlier stages of the disease.
Originally developed by Medivation, enzalutamide is an androgen receptor inhibitor which works by modulating three different steps in the androgen receptor signaling pathway. Medivation and Astellas entered into a global agreement in 2009 to jointly develop and commercialize enzalutamide. The companies are developing enzalutamide for several indications within advanced prostate cancer as well as advanced breast cancer.
Xtandi is expected to be the market leader in prostate cancer with estimated sales of $3.4 billion by 2023, reports the Pharma Letter, while the overall prostate cancer market is expected to double by 2023 to $9.3 billion.
Medivation has also been in the news recently for its license agreement with CureTech for a late stage clinical cancer drug, pidilizumab, which is an immune modulatory anti-PD-1 monoclonal antibody. Under the license agreement, CureTech will manufacture and supply the antibody to Medivation, which will manage the development, regulatory, and commercialization activities. CureTech stands to receive up to $335 million from Medivation under the terms of the deal, including milestone and royalty payments.