Clovis Oncology (CLVS) initiates its TIGER2 registration study for CO-1686 with the dosing of the first patient. The EGFR inhibitor is being evaluated for the treatment of non-small cell lung cancer (NSCLC) in patients with the T790M mutation.
In May, the FDA designated CO-1686 as a Breakthrough Therapy for the treatment of mutant EGFR NSCLC in patients with the T790M mutation after progression on EGFR-directed therapy.
TIGER2 is one of three registration studies in the third-generation inhibitor of mutant EGFR in lung cancer program expected to start this year. 125 patients will participate in the trial. The primary endpoint is overall response rate. Secondary endpoints included duration of response, progression-free survival, overall survival and safety.