Safety and response with nivolumab (anti-PD-1; BMS-936558, ONO-4538) plus erlotinib in patients (pts) with epidermal growth factor receptor mutant (EGFR MT) advanced NSCLC.

8022 Background: Erlotinib is FDA-approved for the first-line treatment of EGFR MT NSCLC, with a median progression free survival (PFS) of 10.4 months. Nivolumab, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, demonstrated encouraging safety and survival outcomes as monotherapy in advanced NSCLC pts. Preclinical data support EGFR pathway activation of PD-L1 expression and immune escape in EGFR driven lung tumors. Interim results from a phase I study evaluating nivolumab + erlotinib in an EGFR MT advanced NSCLC cohort are reported. Methods: Stage IIIB/IV EGFR MT chemotherapy-naive NSCLC pts (EGFR TKI naive or progression post prior TKI therapy) received nivolumab 3 mg/kg IV Q2W + erlotinib 150 mg PO daily until progression/unacceptable toxicity. Objective response rate (ORR) and PFS were evaluated by RECIST 1.1. Results: All pts (n=21) began study treatment ≥10 months prior to data analysis; only 1 pt was EGFR TKI naive. Any-grade treatment-related AEs were reported in a...