P3.02c-098 An Observational Study of the Efficacy and Safety of Nivolumab in Patients with Advanced NSCLC. A Galician Lung Cancer Group: Topic: IT Clinical

Abstract

Nivolumab is an immune checkpoint inhibitor antibody and it has demonstrated durable responses and tolerability in pretreated patients with advanced NSCLC. This is an observational study to evaluate the efficacy and safety of nivolumab in previously treated patients with advanced NSCLC in the expanded access program. Eligibility criteria included, histologically confirmed NSCLC clinical stage IIIB vs IV, evaluable disease, at least one prior therapy, performance status of 0/1 and an adequate organ function. Exclusion criteria included, positive test for hepatitis B, C or human immunodeficiency virus, severe autoinmune disease and patients with systemic corticosteroids or immunosuppressive medications. Patients received nivolumab 3 mg/kg IV (60 min) every 2 weeks until progressive disease (PD) or unacceptable toxicity. The aim of the study was to report the efficacy and safety profile of Nivolumab in pretreated patients with advanced NSCLC of our everyday clinical practice. The exploratory assessments include response rate (RR), progression-free survival (PFS), overall survival (OS) and treatment related adverse events (AEs). From August of 2015 to February of 2016, with a median follow time of 7 months, 66 patients were enrolled from 7 different centers. The patients demographics were: median age 60 years, 19 female and 47 male; 7 never smoked and 59 former or current smoker; 45 patients adenocarcinoma, 4 large-cell carcinoma, 12 squamous-cell carcinoma and 4 NSCLC; 20 stage IIIB and 46 stage IV; 17 with central nervous system metastasis; 30 received 2 or more prior therapy lines and 62 had PS 1. Among 48 patients evaluated, 3% had complete response, 21% partial response, 27% disease stabilization and 21% disease progression. At the time of database lock, the median of PFS was 2.03 IC 95% (1.2-2.7) and OS was not reached. Grade 1-2 treatment related adverse events (AEs) occurred in 38 patients and the most common ones were asthenia (25), rash/pruritis (12), anorexia (7), endocrine (5) and diarrhea (4). Each of the toxicities were manageable and there were no grade 3-4 AEs or treatment-related deaths. Early data from this study suggests that Nivolumab is effective and well tolerated in patients with pretreated advanced NSCLC.