On June 24, 2015 Tokai Pharmaceuticals reported the initiation of ARMOR3-SV, Tokai’s pivotal Phase 3 clinical trial of galeterone in men with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express the AR-V7 splice variant, which is a truncated form of the androgen receptor (AR) that has been associated with non-responsiveness to commonly-used oral therapies for mCRPC (Press release, Tokai Pharmaceuticals, JUN 24, 2015, View Source [SID:1234505799]). Schedule your 30 min Free 1stOncology Demo! Tokai also announced today that the components of the AR-V7 clinical trial assay have been finalized by its collaborator, Qiagen (NASDAQ: QGEN; Frankfurt Prime Standard: QIA), and that global deployment of the assay is now underway.
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"ARMOR3-SV represents an important step forward in bringing precision medicine to patients with prostate cancer, and we are pleased with the progress made by our valued collaborator Qiagen in readying the AR-V7 clinical assay for global implementation," said Jodie Morrison, President and Chief Executive Officer of Tokai. "With worldwide commercial rights to galeterone, our pivotal clinical trial on track to read out by the end of 2016, and a strong financial position, Tokai is well positioned to realize its mission of bringing new therapeutic treatment options to patients with prostate cancer."
"Based on the evidence reported thus far, a diagnostic tool that can predict patient responsiveness to certain therapies should lead to more informed treatment decisions and ultimately better care for prostate cancer patients," said Mary Ellen Taplin, M.D., Director of Clinical Research, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and lead U.S. investigator of ARMOR3-SV. "Given the encouraging clinical data reported to date for galeterone and the precision medicine approach being employed in Tokai’s pivotal trial, this study has the opportunity to alter the treatment landscape for metastatic CPRC patients."
ARMOR3-SV will compare galeterone to Xtandi (enzalutamide) in 148 mCRPC treatment-naïve patients whose prostate tumors express the AR-V7 splice variant. These truncated ARs are missing the C-terminal end of the AR that contains the ligand-binding domain, which is known as C-terminal loss. AR-V7 is the most common form of C-terminal loss. The pivotal trial will employ a precision medicine approach for selection of patients with the AR-V7 splice variant by using an AR-V7 clinical trial assay successfully optimized for global use by Qiagen. The primary endpoint of ARMOR3-SV is radiographic progression-free survival assessed by blinded independent central review. The design of ARMOR3-SV is aligned with feedback obtained from the U.S. Food and Drug Administration and the European Medicines Agency.
ARMOR3-SV has been initiated at more than 15 sites in the United States, with site initiations in Canada and the United Kingdom anticipated later in June. Additional study centers throughout North America, Western Europe and Australia are expected to join the study in the coming months. In addition, with recent finalization of the components of the AR-V7 clinical trial assay, technology transfer activities and training of the global central laboratories are underway, and screening of eligible patients for the splice variant is expected to begin in July. The company expects topline data from ARMOR3-SV to be available by the end of 2016.