Real-world outcomes versus clinical trial results of first-line immunotherapy with or without chemotherapy in patients with metastatic non-small-cell lung cancer: the CORRELATE study

BACKGROUND: Recent data suggest that real-world overall survival (rwOS) and progression-free survival (rwPFS) in patients with metastatic non-small-cell lung cancer (mNSCLC) receiving first-line immunotherapy-based regimens are shorter than reported in randomized controlled trials (RCTs). This retrospective, observational study compared rwOS and rwPFS with outcomes observed in RCTs in patients with mNSCLC who received immunotherapy. PATIENTS AND METHODS: Eligible real-world (RW) patients from the United States Flatiron Enhanced Datamart had mNSCLC, started first-line treatment with an immunotherapy-based regimen between November 2016 and May 2021, and met key eligibility criteria per the registration RCTs for approved anti-programmed cell death (ligand) 1 [PD-(L)1]-based regimens: KEYNOTE-024, KEYNOTE-189, KEYNOTE-407, IMpower150, CheckMate 9LA, and CheckMate 227. rwOS and rwPFS were analyzed using the Kaplan-Meier method, per regimen/study cohort in subgroups by Eastern Cooperative Oncology Group (ECOG) performance status (PS; 0-1 or 2) and PD-L1 expression level (