Updated Safety And Efficacy Results From Phase I/Ii Study Of Hm61713 In Patients (Pts) With Egfr Mutation Positive Non-Small Cell Lung Cancer (Nsclc) Who Failed Previous Egfr-Tyrosine Kinase Inhibitor (Tki).

8084 Background: HM61713 is an orally available EGFR mutation-specific inhibitor with sparing EGFR WT tumors that previously showed promising efficacy in T790M positive tumors at the dose of 300 mg (overall response rate; 29.2%). We report here on updated data from the ongoing phase I/II study of HM61713 in pts with advanced NSCLC who had failed previous EGFR-TKIs (NCT01588145). Methods: Advanced NSCLC pts with EGFR mutation positive tumor were enrolled in dose escalation cohort and received doses ranging from 75-1200 mg/day. After safety evaluation, separate expansion cohorts opened for pts who failed prior EGFR TKI pts at 800 mg QD dose, respectively to investigate efficacy and tolerability of HM61713 in pts with centrally confirmed T790M positive NSCLC. Results: As of 15 Dec 2014, 173 patients were enrolled, 55 and 118 in dose escalation and expansion parts, respectively. Maximum tolerated dose (MTD) was established as 800 mg once daily (QD). Dose limiting toxicities (DLTs) included abdominal pain, dia...