Scott n. Gettinger¹, Matthew D. hellmann², Frances A. shepherd³, Scott Antonia⁴, Julie Brahmer⁵, Laura Q. chow⁶, Jonathan Goldman⁷, Rosalyn Juergens⁸, Hossein Borghaei⁹, Neal E. ready¹⁰, David E. gerber¹¹, Faith,,bristol‐myers squibb, Nathan¹², Yun Shen¹², Christopher Harbison¹², Naiyer Rizvi¹³

¹Medical Oncology, Yale Cancer Center, ²Memorial Sloan Kettering Cance, ³Princess Margaret Cancer Centr, ⁴H. Lee Moffitt Cancer Center & Research Institute, ⁵The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, ⁶University of Washington, ⁷University of California, Los Angeles, ⁸Juravinski Cancer Centre at McMaster University, ⁹Fox Chase Cancer Center, ¹⁰Duke University Medical Center, ¹¹UT Southwestern Medical Center, ¹²Bristol-Myers Squibb, ¹³Memorial Sloan Kettering Cancer Center

Objective: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. 

Method: Pts (N=52) with squamous (SQ) or non-SQ advanced NSCLC received nivo 3mg/kg IV Q2W until progression/unacceptable toxicity. Post-progression treatment was allowed per protocol. Response (RECIST v1.1) was evaluated overall, by histology, and by tumor PD-L1 expression (< or ≥ 5% tumor cells expressing PD-L1). 

Result: Efficacy by histology and PD-L1 expression are shown (Table). Overall, 9/12 (75%) responders responded by 1st scan (wk 11), and 8 (67%) had ongoing responses at last tumor assessment (median follow-up, 62.2 wks). Four pts had ongoing CRs of 41.4+, 97.6+, 101.3 and 112.3+ wks. Non-conventional immune-related responses were seen in 3 pts, with 35%, 43%, and 46% max reduction in target lesions, respectively, and simultaneous appearance of new lesions (not reported as responders). Similar OS and PFS rates were observed in pts with < or ≥5% PD-L1 expression, although ORR was higher in pts with ≥5% PD-L1 expression. 10 pts (19%) had experienced grade 3–4 treatment-related AEs: rash (n=2), increased amylase/lipase, increased AST/ALT, hyperglycemia, cardiac failure, lung infection, pneumonitis, dehydration/diarrhea, and hyponatremia (n=1 each).[Table]. 

Conclusion: 1st-line nivo demonstrated durable responses, encouraging survival and a tolerable safety profile in pts with advanced NSCLC. Although ORR was higher in pts with ≥5% PD-L1 expression, survival rates were encouraging across PD-L1 expression levels. Efficacy for additional PD-L1 expression levels will be presented.

Key Words: nivolumab  NSCLC  PD-L1