Nivolumab in patients with advanced non-small-cell lung cancer (NSCLC): survival and clinical activity by subgroup analysis. — ASN Events
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Nivolumab in patients with advanced non-small-cell lung cancer (NSCLC): survival and clinical activity by subgroup analysis. (#299)

Julie R Brahmer 1 , Leora Horn 2 , Leena Gandhi 3 , David R Spigel 4 , Scott J Antonia 5 , Naiyer A Rizvi 6 , John D Powderly 7 , Rebecca S Heist 8 , Richard D Carvajal 6 , David M Jackman 3 , Lecia V Sequist 9 , David C Smith 9 , Philip D Leming 10 , Suzanne L Topalian 1 , Stephen Hodi 3 , Mario Snzol 11 , Christopher T Harbison 12 , Gerogia D Kollia 12 , Ashok Gupta 12 , Scott N Gettinger 11
  1. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA
  2. Vanderbilt University Medical Center, Nashville, TN, USA
  3. Dana-Farber Cancer Institute, Boston, MA, USA
  4. Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN, USA
  5. H. Lee Moffitt Cancer Centre & Research Institute, Tampa, FL, USA
  6. Memorial Sloan-Kettering Cancer Centre, New York, NY, USA
  7. Carolina BioOncology Institute, Huntersville, NC, USA
  8. Massachusetts General Hospital Cancer Center, Boston, MA, USA
  9. University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA
  10. Christ Hospital Cancer Center, Cincinnati, Ohio, USA
  11. Yale Cancer Center, New Haven, CT, USA
  12. Bristol-Myers Squibb, Princeton, NJ, USA

Aim: Nivolumab, a fully human immunoglobulin-G4 (IgG4), Programmed death-1 (PD-1) immune-checkpoint inhibitor antibody, has shown durable clinical activity in phase I trial of patients with advanced solid tumours. Methods: Previously treated advanced NSCLC patients received nivolumab (1, 3, or 10 mg/kg, i.v.) fortnightly for ≤96 weeks with tumour evaluation (RECIST v1.0). PD-ligand 1 (PD-L1) tumour cell membrane expression was measured (n=68) by immunohistochemistry (positive ≥5% tumour cells). Clinical activity including overall survival (OS) of NSCLC patients by dose, histology (squamous [sq] and non-sq), and PD-L1 tumour status were evaluated. Results: Across doses and histologies, NSCLC patients (N=129, 54% with ≥3 prior therapies) had median overall survival (mOS) (95% CI) of 9.9 months (7.8-12.4) and 1- and 2-year OS (95% CI) rates of 42% (34, 51) and 24 % (16, 32), respectively. The mOS (95% CI) for sq and non-sq histology was 9.2 months (7.3, 12.5) and 10.1 months (5.7, 13.7), respectively. At 3 mg/kg dose, mOS was 14.9 months (7.3, NE); 1- and 2-year OS rates were 56% (38, 71) and 45% (27, 61). Across doses objective response rate was 17% (22/129); median response duration was 17 months. In patients with PD-L1(+) and (–) tumours, mOS was 7.8 months (5.6, 21.7) and 10.5 months (5.2, 21.2), respectively. Grade 3-4 treatment-related adverse events occurred in 14% of patients; most common was fatigue (3%). Conclusions: Nivolumab demonstrated encouraging clinical activity across NSCLC patient subgroups with a manageable safety profile. Phase III trials are evaluating 3 mg/kg nivolumab in patients with NSCLC.

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