PCN4 - EFFECTIVENESS AND SAFETY OF PEMBROLIZUMAB IN ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

To access the effectiveness and safety of pembrolizumab in advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) in a real world context. An ongoing ambidirectional observational cohort study was initiated in 01/06/2017. Adult patients (≥18 years) diagnosed with advanced or metastatic NSCLC and treated with pembrolizumab were identified using the National Oncology Registry. Patients are included in this dynamic cohort regularly and characterized at baseline, including demographics, staging, programmed death ligand 1 (PD-L1) expression and previous treatments. Primary outcome considered will be overall survival (OS) and secondary outcomes progression-free survival (PFS), objective response rate (ORR) and adverse events (AEs). Two independent authors (RM; CR) are responsible for data collection. ORR and disease progression (DP) will be assessed per RECIST v1.1 and validated by an independent oncologist (MF). AEs will be coded using MedDRA and graded with CTCAE v4.03. Fifty-four patients were identified and included so far. Forty-six were male (85.2%). A minority was subject to previous surgery (n=9; 16.7%), curative radiotherapy (n=9; 16.7%), and to palliative radiotherapy (n=16; 29.6%). At treatment initiation, the median age was 66.5 years (IQR 58.0-70.0) and 44 patients had metastatic disease (81.5%). Twenty-two patients received pembrolizumab as 1st line therapy (40.7%) and 26 as 2nd line therapy (48.1%). PD-L1 expression was available in 51 patients: 18 had PD-L1 weak-positive tumours (35.3%) and 33 had PD-L1 strong-positive tumours (64.7%). Tumour response data was preliminarily available for 36 patients and suggests an ORR of 44.4%. Fifteen patients have died (35.2%) and in 23 there is suggestion of disease progression (42.6%). This is an ongoing cohort study. To achieve our objectives, measures were implemented to maximize the identification and characterization of more patients, allowing a more reliable outcome determination. OS, PFS and AEs will be presented at the conference when data is more mature and fully validated.