Finally, some good news as Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited have announced their intention to start a Phase III clinical trial of TAK-700 in the U.S. for men with advanced prostate cancer. TAK-700, which I have been writing about under the heading of “On the Horizon,” is a selective, oral, non-steroidal androgen synthesis inhibitor that in preclinical studies has been shown to selectively bind to and inhibit the enzyme 17,20 lyase in both the testes and adrenal glands.
The planned randomized, double-blind, multi-center, global Phase III study will evaluate TAK-700 with prednisone compared to placebo with prednisone in men with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). Its has as its primary endpoints Overall Survival (OS) and Progression Free Survival (PFS).
“Our hope is that this trial will demonstrate strong levels of efficacy that address the unmet medical needs in advanced prostate cancer,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “The progress of TAK-700 into Phase III study further demonstrates commitment of Millennium and Takeda to advancing the treatment of prostate cancer.
The companies anticipate to open enrollment of a second Phase III clinical trial2 of TAK-700 later this year. This second study will compare TAK-700 plus prednisone versus placebo plus prednisone in patients with mCRPC that have progressed during or following docetaxel-based therapy.
Joel T. Nowak, M.A., M.S.W.