Todd m. Bauer¹, Michael Mccleod², Jason c. Chandler³, George r. Blumenschein⁴, Lee s. Schwartzberg³, Howard Burris⁵, David Waterhouse⁶, Robert m. Jotte⁷, Maen Hussein², David r. Spigel⁵, Dana s. Thompson⁵, Xuemei Li⁸, Craig h. Reynolds⁹

¹ Sarah Cannon Research Institute/Tennessee Oncology, PLLC, ²Florida Cancer Specialists, ³P.C., The West Clinic, ⁴MD Anderson Cancer Center, Jr, ⁵PLLC, Sarah Cannon Research Institute/Tennessee Oncology, ⁶Oncology Hematology Care, ⁷Rocky Mountain Cancer Centers, ⁸Bristol-Myers Squibb, ⁹Ocala Oncology Center (current affiliation: US Oncology Research)

Objective: Nivo, a fully human IgG4 programmed death-1 immune checkpoint inhibitor antibody, has demonstrated durable responses and tolerability in heavily pretreated pts with advanced NSCLC. This ongoing community-based trial explores nivo safety in this population.

Method: Eligible pts are enrolled in 4 subgroups: 1) squamous cell (SQ), performance status (PS) 0–1, ≥2 prior treatments (tx); 2) SQ, PS 0–1, 1 prior tx; 3) non-squamous (NSQ), PS 0–1, ≥1 prior tx; 4) SQ or NSQ, PS 2, ≥1 prior tx. Pts receive 3mg/kg IV Q2W until progressive disease/unacceptable toxicity (Cohort A) or for 1 y with the possibility of retreatment upon disease progression (Cohort B). Primary objective is the incidence of high grade (3–5) select treatment-related adverse events (sTRAEs). Exploratory assessments include ORR, PFS, and OS.

Result: From 4/16–12/31/14, 824 pts were treated; 483 remained on study as of 12/31/14 and 531 had ≥1 on-study radiographic tumor assessment. We report demographics, safety, and tumor response at wk 9. Median follow-up time for this data lock was 10.4 wks.

Conclusion: Safety and tolerability were consistent with prior nivo experience; no new safety signals were identified. Immune-related AEs were manageable using previously developed safety algorithms. Frequency of sTRAEs of interest was similar in pts with PS 0–1 and 2. Early data suggest that pts with pretreated advanced NSCLC respond to nivo tx regardless of PS, histology type, EGFR/ALK mutation status and lines of prior tx.

Key Words: nivolumab  NSCLC  safety