Poster Presentation COSA 2015 ASM

Longer-term follow-up of a phase 2 study (CheckMate 063) of nivolumab in patients with advanced refractory squamous (SQ) non-small cell lung cancer (NSCLC) (#200)

Leora Horn 1 , Naiyer Rizvi 2 , Julien Mazières 3 , David Planchard 4 , Thomas E Stinchcombe 5 , Grace K Dy 6 , Scott J Antonia 7 , Herve Lena 8 , Elisa Minenza 9 , Bertrand Mennecier 10 , Gregory A Otterson 11 , Luis T Campos 12 , David R Gandara 13 , Benjamin P Levy 14 , Suresh G Nair 15 , Gerard Zalman 16 , Juergen Wolf 17 , Paul Paik 2 , Jin Zhu 18 , Dong Xu 18 , Jaclyn Neely 18 , Zenhao Qi 18 , Christopher T Harbison 18 , Mark Lynch 18 , Suresh S Ramalingam 19
  1. Vanderbilt University Medical Center, Nashville, TN, USA
  2. Memorial Sloan-Kettering Cancer Centre, New York, NY, USA
  3. Hôpital Larrey, Centre Hospitalier Universitaire de Toulouse, Toulouse, France
  4. Cancer Institute Gustave Roussy, Villejuif, France
  5. University of North Carolina School of Medicine, Chapel Hill, NC, USA
  6. Roswell Park Cancer Institute, Buffalo, NY , USA
  7. H. Lee Moffitt Cancer Centre & Research Institute, Tampa, FL, USA
  8. Centre Hospitalier Universitaire de Rennes, Rennes, France
  9. Ospedale S. Maria, Terni, Italy
  10. Centre Hospitalier Universitaire, Strasbourg, France
  11. The Ohio State University Medical Center, Colombus, OH, USA
  12. Oncology Consultants, PA, Houston, TX, USA
  13. University of California Davis Cancer Center, Sacramento, CA, USA
  14. Beth Israel Deaconess Medical Center, Boston, MA, USA
  15. Lehigh Valley Hospital, Allentown, PA, USA
  16. Centre Hospitalier Universitaire de Caen , Caen, France
  17. Universitaetsklinik Köln, Köln, Germany
  18. Bristol-Myers Squibb, Princeton, NJ, USA
  19. Winship Cancer Institute, Emory University, Atlanta, GA, USA

Aim: To report the efficacy, safety, and biomarker analyses of patients with SQ NSCLC treated with nivolumab after progression during/after prior platinum-based doublet chemotherapy and ≥1 additional systemic regimen.

Methods: Patients (N=117) receivednivolumab 3 mg/kg Q2W until progressive disease (PD)/unacceptable toxicity; treatment beyond PD was permitted. The primary endpoint was independent radiology review committee (IRC)-assessed overall response rate (ORR) (per RECIST v1.1). Additional objectives included investigator-assessed ORR, progression-free survival (PFS), overall survival (OS), safety, ORR by patient subgroups, efficacy by tumor programmed death ligand-1 (PD-L1) expression (PD-L1+: ≥5%), and blood-based biomarker analyses.

Results: After ≥11 months of follow-up, IRC-assessed ORR was 15% (95% CI: 9, 22). Median duration of response was not reached (range, 2+–12+ months); 76% (13/17) had ongoing responses. Objective responses were observed regardless of tumor PD-L1 expression.One-year OS was 41% (95% CI: 32, 50) and median OS was 8.2 months (95% CI: 6.1, 10.9). One-year PFS was 20% (95% CI: 13, 29);median PFS was 1.9 months (95% CI: 1.8, 3.2). Of 22 patients treated beyond PD, 4 demonstrated non-conventional benefits (ie,persistent reduction in target lesions in the presence of new lesions, regression following initial progression, or ≥2 tumor assessments with no further progression); OS for these patientswas 6.6, 11.6+, 12.9+, and 13.5+ months. Peripheral increases in serum interferon-γ-stimulated cytokines, including CXCL9 andCXCL10, were observed. Preliminary microRNA analyses identified altered gene expression following nivolumab treatment; 17% ofpatients experienced grade 3–4 treatment-related adverse events (fatigue 4%, diarrhea 3%, and pneumonitis 3%). Pneumonitis was manageable with corticosteroids; median time to resolution was 3.4 weeks (range, 0.7–13.4). Two treatment-related deaths (hypoxic pneumonia, ischemic stroke) occurred in patients with multiple comorbidities and concurrent PD.

Conclusions: Nivolumab demonstrated clinically meaningful efficacy and an acceptable safety profile in patients with advanced, refractory SQ NSCLC.