Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced NSCLC: CheckMate 078 Randomized Phase III Clinical Trial

Abstract

Introduction: Data on immuno-oncology agents in Chinese patients are limited despite a need for new therapies. We evaluated the efficacy and safety of nivolumab in a predominantly Chinese patient population with previously treated NSCLC. Methods: CheckMate 078 was a randomized, open-label, phase III clinical trial in patients from China, Russia, and Singapore with squamous or nonsquamous NSCLC that had progressed during/after platinum-based doublet chemotherapy (ClinicalTrials.

The landscape of immune checkpoint inhibitor plus chemotherapy versus immunotherapy for advanced non‐small‐cell lung cancer: A systematic review and meta‐analysis

“…A total of 3,691 related studies were identified by the initial search strategy ( Figure S1). Finally, 20 randomized controlled trails with 22 studies involving 12,025 patients were included for the quantitative analysis (Barlesi et al, 2018;Borghaei et al, 2015;Borghaei et al, 2018;Brahmer et al, 2015;Carbone et al, 2017;Fehrenbacher et al, 2016;Gandhi et al, 2018;Govindan et al, 2017;Hellmann et al, 2018;Herbst et al, 2016;Jotte et al, 2018;Langer et al, 2016;Lynch et al, 2012;Mok et al, 2019;Papadimitrakopoulou et al, 2018;Paz-Ares et al, 2018;Reck et al, 2016;Rittmeyer et al, 2017;Socinski et al, 2018;West et al, 2019;Wu et al, 2019). Half of these 22 studies investigated the efficacy of ICI monotherapy versus chemotherapy, including 1 study about avelumab, 2 about ATE, 4 about NIV, and 4 about PEM.…”

Patterns of response in metastatic NSCLC during PD‐1 or PD‐L1 inhibitor therapy: Comparison of the RECIST 1.1 and iRECIST criteria

“…Immune checkpoint inhibitors (ICIs) targeting programmed cell death-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) play an important role in the treatment of advanced non-small cell lung cancer (NSCLC) without targeted gene mutations, 2,3 which can significantly prolong the overall survival (OS) of patients with advanced NSCLC compared with traditional chemotherapy. [4][5][6][7][8][9][10][11][12][13][14][15][16] At present, nivolumab, pembrolizumab, atezolizumab, and durvalumab have been approved by the United States Food and Drug Administration for the treatment of NSCLC.…”

Racial differences in characteristics and prognoses between Asian and white patients with nonsmall cell lung cancer receiving atezolizumab: An ancillary analysis of the POPLAR and OAK studies

“…However, most participants in clinical trials of immune‐checkpoint inhibitors have come from western countries, with Asian/East Asian patients accounting for only 3%–25.2% of the study populations in clinical trials of PD‐1/PD‐L1 inhibitors for NSCLC . Few studies have thus reported on the efficacy of immunotherapy and the related characteristics in Asian patients …”

“…6.9 months) . The CheckMate 078 trial enrolled predominantly Chinese patients with NSCLC and showed similar efficacy of nivolumab to the CheckMate 017/057 . However, no studies have yet provided direct comparative data regarding the differences in characteristics and prognoses between Asian and white patients with NSCLC, and the relationship between racial differences and the efficacy of immunotherapy remains unclear.…”

“…3,4,6,10 Few studies have thus reported on the efficacy of immunotherapy and the related characteristics in Asian patients. [11][12][13][14] Current evidence from clinical trials suggests that PD-1/PD-L1 inhibitors may have comparable or better efficacy in Asian patients compared to white patients with advanced NSCLC. An East Asian population demonstrated greater sensitivity to firstline treatment with pembrolizumab (KEYNOTE-024) than a non-East Asian population (hazard ratio [HR] for disease progression or death: 0.35 [0.14-0.91] vs. 0.52 [0.38-0.72]), though pembrolizumab showed similar pharmacokinetic characteristics in Asians and Caucasians.…”