P3.02c-101 Immunotherapy with Nivolumab in NSCLC Patients: One Centre Preliminary Results: Topic: IT Clinical

Abstract

Nivolumab is an IgG4 monoclonal antagonist antibody to PD-1 that is approved for the treatment of patients with advanced squamous and non-squamous NSCLC with progression of disease on or after standard platinum-based chemotherapy, regardless of tumor PD-L1 protein expression. The aim of our study is to evaluate the efficacy and safety of nivolumab in this group of patients. We enrolled 23 patients with squamous and non-squamous NSCLC, stage IIIB-IV,19 males and 4 females, with median age 68 years who had failed two or more lines of systemic platinum based chemotherapy. All patients received at least 4 doses of nivolumab as monotherapy, at a dose of 3 mg/kg once every 2 weeks intravenously, until disease progression or unacceptable toxicity. 3 (13%) of 23 patients had an objective response as assessed by RECIST criteria and all of the responses were ongoing at the time of analysis. 19 (82.6%) of 23 patients had stable disease and one experienced progression of the disease. 2 (9%) of 23 patients reported treatment-related adverse events, including peripheral edema, one (4%) with pleural effusion and one (4%) with pericardial effusion, which all were well tolerated and treated. No deaths were attributed to nivolumab. Nivolumab has clinically meaningful activity and a manageable safety profile in previously treated patients with advanced, resistant, squamous and non-squamous non-small cell lung cancer.