![]() Cancer Medicine published by John Wiley & Sons Ltd. ![]() PD-L1 tumor proportion score Real world first-line monotherapy non-small cell lung cancer pembrolizumab. In a real-life cohort of advanced NSCLC patients (including PS 2 and untreated brain metastases), with PD-L1 TPS ≥50%, pembrolizumab demonstrates similar PFS to the pivotal clinical trial. Treatment-related adverse events (AE) of grade 3 occurred in 8% of patients. KEYNOTE024 was a randomized, multicenter, openlabel, activelycontrolled trial in patients with mNSCLC whose tumors had high PDL1 expression (TPS 50) as determined by immunohistochemistry (IHC) at a central laboratory and who had not received prior systemic treatment for mNSCLC. At 6 months, the OS rate estimated was 86.2%. The objective response rate was 57.3% (complete response 2.7%, partial response 54.6%). With a median follow-up of 8.2 months, the median PFS was 10.1 months (95% CI, 8.8-11.4). ![]() Eighty-seven percent had stage IV NSCLC at diagnosis, 9.2% untreated brain metastases at inclusion. Patient-reported outcomes were not evaluated in this study, but have been previously reported from KEYNOTE-024, which showed clinically meaningful improvement in health-related quality of life with pembrolizumab versus platinum-based chemotherapy as first-line treatment in patients with metastatic non-small-cell lung cancer and PD-L1 tumour. The main characteristics of the cohort were: median age 66.7 years, 64.8% male, 23.1% with a performance status (PS) of 2, and 88.9% current or former smokers. Patient data were obtained from medical files. Findings: Between Aug 28, 2013, and Feb 27, 2015, we enrolled 1034 patients: 345 allocated to pembrolizumab 2 mg/kg, 346 allocated to pembrolizumab 10 mg/kg, and 343 allocated to docetaxel. This was a French retrospective multicenter longitudinal study of 108 consecutive patients with advanced NSCLC, a PD-L1 TPS ≥50% and without EGFR/ALK aberrations who were treated by pembrolizumab, in first line. This trial is registered at, number NCT01905657. The main aim of this study was to report the efficacy and safety profile of pembrolizumab in real-life conditions. The KEYNOTE-024 trial demonstrated that pembrolizumab, a PD-1 inhibitor, significantly improves progression-free survival (PFS) and overall survival (OS) in selected patients with previously untreated advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score (TPS) ≥50% and without EGFR/ALK aberrations.
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