1251PUPDATED ANALYSIS OF RESPONSE AND PATIENT-REPORTED OUTCOMES (PRO) IN TWO LARGE OPEN-LABEL, PHASE III STUDIES (LUX-LUNG 3 [LL3] AND LUX-LUNG 6 [LL6]) OF AFATINIB (A) VERSUS CHEMOTHERAPY (CT) IN PATIENTS (PTS) WITH ADVANCED NSCLC HARBORING EGFR MUTATIONS (MUT)

Aim: A, an oral, irreversible ErbB family blocker of EGFR, HER2, ErbB3 and ErbB4 signalling, improved progression-free survival (PFS), showed higher objective response rates (ORR), faster time to response (TTR) and favourable trends in PROs versus cisplatin/pemetrexed (LL3; 345 pts recruited globally) and cisplatin/gemcitabine (LL6; 364 Asian pts) in treatment-naïve pts with stage IIIB/IV EGFR mut positive NSCLC. We present an updated analysis of PFS, response and PRO data.Methods: Pts were randomized 2:1 to 40 mg A or up to 6 cycles of CT. The primary endpoint was PFS; secondary endpoints included ORR and PROs. PROs were assessed by EORTC QLQ-C30 and QLQ-LC13 questionnaires from randomization until disease progression. Updated PFS, response and PRO analyses were completed at the time of primary OS analysis, during which 21 (LL3) and 23 (LL6) pts were still on A treatment …