OBJECTIVES : In June 2018, nivolumab became the first immuno-oncology agent to be approved by the China National Drug Administration for second-line (2L) treatment of advanced non-small cell lung cancer (aNSCLC) based on significantly improved overall survival (OS) compared with docetaxel in the predominantly Chinese pivotal phase 3 CheckMate-078 (CM-078) trial. Given real-world effectiveness of newly approved therapies is of increasing interest to payers and decision makers, this study within the Flatiron Health (FH) electronic health records database assessed the effectiveness of nivolumab 2L treatment of aNSCLC in real-world patients of Asian ethnicity.

METHODS : FH includes data from over 260 community oncology practices in the USA. Asian patients, with Eastern Cooperative Oncology Group (ECOG) score 0-1, initiating nivolumab for 2L treatment of aNSCLC from 9^th October 2015 to 30^th September 2018 were analysed. Prior platinum doublet-based chemotherapy was not a requirement for inclusion. Median and 1-year OS were estimated using the Kaplan-Meier method. Follow-up was from nivolumab initiation to death with patients censored at last known visit.

RESULTS : During the study period 30 Asian patients with ECOG 0-1 in FH received nivolumab as 2L aNSCLC therapy. Compared to Chinese patients in CM-078, the FH cohort were similar in terms of sex (73%), histology (30% squamous, 63% non-squamous, 7% unknown) and central nervous system metastases (17%), but differed with a higher proportion of patients ≥75 years (30%), fewer patients with ECOG=1 (50%) and no patients with nivolumab as third or fourth-line of therapy. Median follow-up was 9.7 months. Median OS (95% confidence interval) was 12.7 (6.3─20.2) vs. 11.9 (10.2–13.8) months in Chinese patients in CM-078. The 1-year OS rate was 52.5%.

CONCLUSIONS : In this real-world population of Asian patients with aNSCLC, nivolumab as 2L therapy showed a similar overall survival benefit to that demonstrated in the predominantly Chinese CM-078 clinical trial.