Real-world outcomes of Italian patients with advanced non-squamous lung cancer treated with first-line pembrolizumab plus platinum-pemetrexed

Purpose: The aim of this multi -center, retrospective/prospective cohort observational study was to evaluate outcomes in routine clinical practice of first -line chemo-immunotherapy with cis/carboplatin, pemetrexed and pembrolizumab in patients with advanced non-squamous non -small cell lung cancer (NSCLC) in 33 Italian centers. Methods: The outcome measure was to evaluate overall survival (OS) in a real -world patient population. Secondary endpoints were: progression -free survival (PFS), objective response rate (ORR), duration of response (DoR) and incidence of treatment -related adverse events (AEs). Results: 1068 patients were enrolled at the time of data cut-off (January 31st, 2023), and 812 (76.0%) belonged to the retrospective cohort. Median age was 66 years (27-85), ECOG PS was >= 2 in 91 (8.6%) patients; 254 (23.8%) patients had brain metastases at baseline; 38 (3.6%) patients had tumor with PD -L1 expression >= 50%. After a median follow-up of 17.0 months (95% CI, 16.1-17.9), median OS was 16.1 months (95% CI, 14.4-18.8) and PFS was 9.9 months (95% CI, 8.8-11.2). Median DoR (n = 493) was 14.7 months (95% CI, 13.6-17.1). ORR was 43.4% (95% CI, 40.4-46.4). Any -grade AEs occurred in 636 (59.6%) patients and grade >= 3 in 253 (23.7%) patients. Most common grade >= 3 AEs were neutropenia (6.3%) and anemia (6.3%). Conclusions: First -line chemo-immunotherapy was effective and tolerable in this large, real -world Italian study of patients with advanced non-squamous NSCLC. Our results were in line with the KEYNOTE -189 registration study, also considering the low number of PD -L1 >= 50% patients included in our study.