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Aim: To determine real-world outcomes with first-line pembrolizumab monotherapy for metastatic non-small-cell lung cancer with PD-L1 tumor expression ≥50%. Methods: This retrospective study included adults with ECOG 0–1 initiating first-line pembrolizumab monotherapy on/after 24 October 2016 (EHR cohort) or from 1 December 2016 through 30 November 2017 (spotlight cohort) with ≥6-month follow-up. We estimated Kaplan–Meier overall survival (OS, both cohorts), and, for spotlight, real-world progression-free survival (rwPFS) by Kaplan–Meier and real-world tumor response (rwTR). Results: For 423 patients in the EHR cohort and 188 in spotlight, median OS was 18.9 months (95% CI: 14.9–25.5) and 19.1 months (12.6-not reached), respectively. For spotlight, median rwPFS was 6.8 months (5.3–8.1); rwTR of complete/partial response was 48% (41–56%). Conclusion: Observed OS, rwPFS and rwTR were consistent with clinical trial findings.

Outcomes of first-line pembrolizumab monotherapy for PD-L1-positive (TPS ≥50%) metastatic NSCLC at US oncology practices