Real-world safety of pemetrexed, carboplatin, and pembrolizumab in U.S. NSCLC patients.

Abstract

50 Background: A Phase 3 KEYNOTE-189 clinical trial showed improved clinical benefit with acceptable toxicity of pemetrexed combined with pembrolizumab and platinum (Gandhi, 2018). However, the safety data with this combination has not been evaluated in a real-world setting with large number of patients with non-squamous non-small cell lung cancer (NSQ NSCLC). Methods: Flatiron Health’s electronic health record-derived data were used to identify advanced NSQ NSCLC patients (≥18 y) who received pemetrexed, pembrolizumab, and carboplatin (≤6 cycles; Pem+Pembro+Carb) as initial treatment from May 2017 to Oct 2018. Endpoints were overall occurrence of select laboratory adverse events (AEs; any Grade and Grade ≥3), which were described by treatment phase (Pem/Pembro cycles < 5 vs ≥5) and pre-specified subgroups. Results: The study included 1088 patients (median age = 68 y; male, 57%). In patients with maintenance (Pem/Pembro ≥5) cohort (N = 462), the median number of treatment cycles was 9 for Pembro and 6 for Pem. The occurrence rates of neutrophil count decrease and platelet count decrease were numerically higher in the induction phase, whereas those of chronic kidney disease (CKD) showed an opposite trend (Table). Grade ≥3 CKD occurrence rate was higher in patients with mild renal impairment (5.1% vs 2.6%) and elderly (≥75 y) patients (7.5% vs 3.3%). Conclusions: Considering the heterogeneity and vulnerability of real-world population, the laboratory AE occurrence rate with Pem+Pembro+Carb in this study was comparable with those reported in KEYNOTE-189. Various trends were observed for the respective AEs by treatment phase. [Table: see text]