First-line monotherapy with nivolumab (NIVO; anti-programmed death-1 [PD-1]) in advanced non-small cell lung cancer (NSCLC): Safety, efficacy and correlation of outcomes with PD-1 ligand (PD-L1) expression.

8025 Background: NIVO, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, has demonstrated durable responses and tolerability in heavily pretreated patients (pts) with advanced NSCLC. This phase I study evaluated the efficacy and safety of NIVO monotherapy in pts with chemotherapy naïve advanced NSCLC. Methods: Pts (N=52) with squamous (SQ) or non-SQ advanced NSCLC received NIVO 3 mg/kg IV Q2W until progression or unacceptable toxicity (post-progression treatment was permitted per protocol). Response (RECIST v1.1) was evaluated overall, by histology and by tumor PD-L1 expression (PD-L1+: ≥5% tumor cells expressing PD-L1). Results: Objective response rate (ORR) was 21%, with 3 confirmed complete responses; 9/11 responders (82%) achieved response by first scan (wk 11). Median duration of response (mDOR) was not reached (NR; range, 7.6+, 85.6+ wks); 9 pts (82%) had ongoing responses at last tumor assessment, with a minimum follow-up of 8 mos in all pts. Two pts had unconventional immune-pattern responses with 35% and 43% maximum reductions in target lesions, respectively, and simultaneous appearance of new lesions (not reported as responders). Median overall survival (mOS) was 98.3 wks (range, 1.0, 104.4+). Objective responses were observed in both PD-L1+ and PD-L1– pts, with ORR higher in pts with PD-L1+tumors. Eight pts (15%) experienced grade 3–4 treatment-related adverse events, including rash (n=2), increased amylase/lipase, increased AST/ALT, hyperglycemia, cardiac failure, lung infection, and pneumonitis (n=1 each). Conclusions: First-line NIVO demonstrated durable responses, encouraging survival and a tolerable safety profile in pts with advanced NSCLC. Although response rates were higher in PD-L1+ pts, OS was encouraging in both PD-L1+ and PD-L1– pts. Updated OS and safety data will be presented. Clinical trial information: NCT01454102. ORR mDOR mOS n/N (%) wks (range) All pts 11/52 (21) NR (7.6+, 85.6+) 98.3 (1.0, 104.4+) Non-SQ 9/39 (23) NR (7.6+, 85.6+) NR (1.0, 104.4+) SQ 2/13 (15) NR (46.9+, 77.3+) 73.1 (13.3, 87.3+) PD-L1+ 8/26 (31) NR (7.6+, 85.6+) NR (1.0, 103.3+) PD-L1 2/21 (10) NR (13.0+, 24.1+) 98.3 (8.0, 104.4+)

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