Clovis Oncology Initiates TIGER 2 Non-small Cell Lung Cancer Study With CO-1686

(RTTNews) - Clovis Oncology, Inc. (CLVS) 's TIGER2 study, involving drug candidate CO-1686 has begun with the dosing of the first patient at a U.S. study site. CO-1686 is used for the treatment of non-small cell lung cancer or NSCLC in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M. It is expected to be a potential replacement for chemotherapy treatment, which is considered to be often ineffective, with more side effects.

The TIGER2 or Third-generation inhibitor of mutant EGFR in lung cancer study is being conducted in T790M positive patients directly after progression on their first and only TKI therapy. The trial is currently enrolling 125 patients with EGFR-mutant NSCLC with a centrally-confirmed T790M mutation who will receive CO-1686 at the recommended Phase 2 dose of 625mg BID. The primary study endpoint is overall response rate; secondary endpoints include duration of response, progression-free survival, overall survival, and safety. In addition to TIGER2, Clovis is currently enrolling two Phase 2 expansion cohorts of its Phase 1/2 study in EGFR mutant patients with the T790M mutation. Data from both the expansion cohorts and TIGER2, are expected to form the basis of an NDA filing by the company for CO-1686 by mid-2015.

Last month, CO-1686 had received breakthrough therapy designation from the FDA, as monotherapy for the treatment of mutant EGFR NSCLC in patients with the T790M mutation after progression on EGFR-directed therapy.