BIOMARKER ANALYSES AND OVERALL SURVIVAL (OS) FROM THE RANDOMIZED, PLACEBO-CONTROLLED, PHASE 3, FASTACT-2 STUDY OF INTERCALATED ERLOTINIB WITH FIRST-LINE CHEMOTHERAPY IN ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC)

Background FASTACT-2 is a randomized, placebo-controlled, phase 3 study in first-line advanced NSCLC, which met its primary endpoint of significantly prolonged PFS with intercalated erlotinib and chemotherapy: median 7.6 vs 6.0 months; HR= 0.57; p< 0.0001 (Mok et al. ASCO 2012). We report OS results and correlations of biomarkers with PFS for this study. Methods Patients (pts) with untreated stage IIIB/IV NSCLC and ECOG PS 0/1 received up to 6 cycles of gemcitabine (1,250 mg/m 2 on d1 & 8) plus platinum (carboplatin AUC= 5 or cisplatin 75 mg/m 2 on d1) q4w, with either intercalated erlotinib (150 mg/day on d15–28; GC-E; n= 226) or placebo (GC-P; n= 225). Pts without progression received maintenance erlotinib or placebo until progression, unacceptable toxicity or death. Provision of tumour samples was encouraged; tests were conducted at a central laboratory and prioritized as follows: EGFR …