Nivolumab (anti-PD-1; BMS-936558, ONO-4538) in combination with platinum-based doublet chemotherapy (PT-DC) in advanced non-small cell lung cancer (NSCLC).

Lung Cancer - Non-Small Cell Metastatic
Session Type and Session Title: 
General Poster Session, Lung Cancer - Non-Small Cell Metastatic
Abstract Number: 
J Clin Oncol 32:5s, 2014 (suppl; abstr 8113)
Scott Joseph Antonia, Julie R. Brahmer, Scott N. Gettinger, Laura Quan Man Chow, Rosalyn A. Juergens, Frances A. Shepherd, Scott Andrew Laurie, David E. Gerber, Jonathan Wade Goldman, Yun Shen, Christopher Harbison, Suresh Alaparthy, Allen C. Chen, Hossein Borghaei, Naiyer A. Rizvi; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Yale Cancer Center, New Haven, CT; University of Washington, Seattle, WA; Juravinski Cancer Centre, Hamilton, ON, Canada; Princess Margaret Hospital, Toronto, ON, Canada; Ottawa Hospital Cancer Centre, Ottawa, ON, Canada; The University of Texas Southwestern Medical Center, Dallas, TX; University of California, Los Angeles, Los Angeles, CA; Bristol-Myers Squibb, Princeton, NJ; Fox Chase Cancer Center, Philadelphia, PA; Memorial Sloan-Kettering Cancer Center, New York, NY

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures


Background: First-line PT-DC has demonstrated 1-yr overall survival (OS) rates of up to 54% in NSCLC; however, there remains a need for therapies with improved long-term survival. We report an updated analysis of a phase I multi-cohort study evaluating nivolumab, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, plus PT-DC in chemotherapy-naive patients (pts) with advanced NSCLC, with longer follow up and additional pts. Methods: Pts (N=56) with advanced NSCLC were assigned based on histology to 4 cohorts to receive nivolumab 10 mg/kg IV Q3W plus concurrent IV gemcitabine 1250 mg/m2 + cisplatin 75 mg/m2 (squamous [sq]) or pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (non-sq), or nivolumab 5 or 10 mg/kg IV Q3W plus IV paclitaxel 200 mg/m2+ carboplatin AUC6 (sq + non-sq), in a phase I dose de-escalation trial to assess dose-limiting toxicity (DLT). PT-DC was given for 4 cycles, followed by nivolumab until progression or unacceptable toxicity. Objective response rate (ORR) was assessed by RECIST 1.1. Results: No DLTs were seen during the first 6 wks of treatment. Grade 3-4 treatment-related adverse events were reported in 45% of pts (25-73% across arms), including pneumonitis (4 pts, 7%; managed by protocol algorithm), and fatigue and acute renal failure (3 pts [5%] each). Across arms, ORR (≥10 months follow up) was 33–50% and progressive disease (PD) as best overall response (BOR) was infrequent (Table). One-year OS rates were 59–87% (Table). Conclusions: Nivolumab combined with standard PT-DC regimens used for first-line treatment of NSCLC demonstrated antitumor activity, with encouraging 1-yr OS and an acceptable tolerability profile. Clinical trial information: NCT01454102.

Nivo 10 + gem/cis
Nivo 10 + pem/cis
Nivo 10 + pac/carb
Sq + Non-sq
Nivo 5 + pac/carb
Sq + Non-sq
N 12 15 15 14
ORR, a n (%) 4 (33) 7 (47) 7 (47) 7 (50)
Median duration of response
(Kaplan-Meier),a wk (range)
Not reached
PD as BOR, n (%) 0 0 3 (20) 1 (7)
PFS rate wk 24, % 36 71 38 57
1-yr OS, % 59 87 59 Insufficient

a Confirmed responses only. + Ongoing.