advanced NSCLC - Oxford Journals - Oxford University Press

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5Thoracic Oncology, Hôpital Larrey, Centre Hospitalier Universitaire de Toulouse,. Toulouse ... abstracts. Annals of Oncology 26 (Supplement 1): i29–i44, 2015.
Annals of Oncology 26 (Supplement 1): i29–i44, 2015 doi:10.1093/annonc/mdv050.8

Emory University, Atlanta, GA, USA

advanced NSCLC 104PD

PHASE 2 STUDY OF NIVOLUMAB (ANTI-PROGRAMMED DEATH-1 [PD-1]) IN PATIENTS (PTS) WITH ADVANCED, REFRACTORY SQUAMOUS (SQ) NON-SMALL CELL LUNG CANCER (NSCLC)

G. Zalcman1, N.A. Rizvi2, H. Lena3, J. Wolf4, J. Mazieres5, S.J. Antonia6, E. Minenza7, D. Planchard8, B.J. Lestini9, S.S. Ramalingam10 1 Pneumonology, CHU de Caen, Caen, France 2 Thoracic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA 3 Oncology and Pulmonology, Centre Hospitalier Universitaire de Rennes, Rennes, France 4 Pulmonary Oncology, Universitaetsklinik Koeln, Cologne, Germany 5 Thoracic Oncology, Hôpital Larrey, Centre Hospitalier Universitaire de Toulouse, Toulouse, France 6 Thoracic Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA 7 Oncology, Ospedale S. Maria, Terni, Italy 8 Thoracic Oncology, Gustave Roussy, Villejuif, France 9 Oncology Global Clinical Research, Bristol-Myers Squibb, Princeton, NJ, USA 10 Department of Hematology & Medical Oncology, Winship Cancer Institute,

Aim: Pts with SQ NSCLC refractory to multiple prior treatment regimens have poor outcomes. We report results from a phase 2, single-arm study of nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, in pts with advanced, refractory, SQ NSCLC (NCT01721759). Methods: Pts (≥2 prior therapies) (N = 117) received nivolumab 3 mg/kg every 2 wks until progression or unacceptable toxicity. Primary endpoint was confirmed objective response rate (ORR), assessed by an independent radiology review committee (IRC) per RECIST v1.1. Secondary and exploratory objectives included investigator-assessed ORR, progression-free survival (PFS), overall survival (OS), safety, and ORR by pt subgroups and by PD-L1 status (PD-L1+ defined as ≥5% of tumor cells with cell surface staining). Results: IRC-assessed ORR was 15% (17/117) with a minimum of 11 mos follow-up. Median time to response was 3 mos (range, 2–9) with median duration of response not reached (range, 2+ to 12+ mos) and 76% (13/17) of responses ongoing. An additional 26% of pts had stable disease with median duration of 6 mos. One-year PFS rate was 20% (95% CI: 13, 29) and median PFS was 2 mos (95% CI: 2, 3). One-year OS rate was 41% (95% CI: 32, 50) and median OS was 8 mos (95% CI: 6, 11). Objective responses were observed across subgroups including age and prior therapies (Table). ORRs for pts with PD-L1+ and PD-L1− tumors were 24% (6/25) and 14% (7/51), respectively. Grade 3–4 treatment-related adverse events (AEs) were reported in 17% of pts,

Characteristic

All treated pts (N = 117) % (n)

ORR % (n/N) [95% CI]

Age, yrs