Abstract CT114: Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer (NSCLC): results of the phase 3 CheckMate 078 study
Authors: Wu Yi-Long , Lu Shun , Cheng Ying , Zhou Caicun , Wang Jie , Mok Tony , Zhang Li , Tu Haiyan , Wu Lin , Feng Jifeng , Zhang Yiping , Luft Alexander Valeriercich , Zhou Jianying , Ma Zhiyong , Lu You , Hu Chengping , Shi Yuankai , Baudelet Christine , Li Zoe , Chang Jianhua 
Published: August 2018

Abstract
Introduction: Lung cancer incidence in China has increased and it remains the leading cause of cancer death, highlighting a need for new treatments. We report results from CheckMate 078, the first phase 3 study of an anti-programmed death (ligand) 1 (PD-[L]1) agent in predominantly Chinese patients with NSCLC and disease progression after platinum (Pt)-based chemotherapy.
Methods: Patients who had disease progression during or after Pt-based doublet chemotherapy were randomized 2:1 to receive nivolumab (3 mg/kg Q2W) or docetaxel (75 mg/m2 Q3W). Patients were included regardless of tumor histology or PD-L1 expression, and randomization was stratified according to both of these factors (≥1% vs &lt;1%/unevaluable tumor PD-L1; squamous vs non-squamous histology). Patients with epidermal growth factor receptor mutation-positive tumors were excluded. The primary endpoint was overall survival (OS); other endpoints included progression-free survival (PFS) and objective response rate (ORR).
Results: 639 patients were enrolled from December 2015 to December 2016; 504 were randomized. Of all randomized patients, ~90% were from China, 60% had non-squamous tumor histology; tumor PD-L1 expression was &lt;1% in 41% of patients and ≥1% in 50% of patients (9% unevaluable). Minimum follow-up was 8.8 months. OS was significantly improved with nivolumab (n=338) vs docetaxel (n=166); median OS was 12.0 vs 9.6 months, respectively (hazard ratio [HR; 97.7% CI]: 0.68 [0.52, 0.90]; P&lt;0.001). The HR (95% CI) for OS was 0.61 (0.42, 0.89) in patients with squamous NSCLC and 0.76 (0.56, 1.04) in patients with non-squamous NSCLC. In patients with tumor PD-L1 expression &lt;1% and ≥1%, the HR (95% CI) was 0.75 (0.52, 1.09) and 0.62 (0.45, 0.87), respectively. Median PFS was 2.8 months in both treatment arms; PFS curves began to separate at 3 months, resulting in a PFS advantage with nivolumab (HR [95% CI]: 0.77 [0.62, 0.95]; P=0.0147). ORR was 17% with nivolumab vs 4% with docetaxel; median duration of response was not reached with nivolumab (95% CI: 11.1 months, not available [NA]) and 5.3 (95% CI: 3.58, NA) months with docetaxel. Rates of grade ≥3 treatment-related adverse events were lower among patients treated with nivolumab (10%) vs docetaxel (48%).
Conclusions: In this population of patients with advanced NSCLC previously treated with Pt-based chemotherapy, nivolumab demonstrated superior OS, PFS, and ORR compared with docetaxel. Efficacy and safety of nivolumab in this first randomized controlled trial of nivolumab in NSCLC in a predominantly Chinese patient population were consistent with the results of the pivotal global CheckMate 017/057 studies.
Citation Format: Yi-Long Wu, Shun Lu, Ying Cheng, Caicun Zhou, Jie Wang, Tony Mok, Li Zhang, Haiyan Tu, Lin Wu, Jifeng Feng, Yiping Zhang, Alexander Valeriercich Luft, Jianying Zhou, Zhiyong Ma, You Lu, Chengping Hu, Yuankai Shi, Christine Baudelet, Zoe Li, Jianhua Chang. Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer (NSCLC): results of the phase 3 CheckMate 078 study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr CT114.