FP04.01 Nivolumab 480 mg Every 4 Weeks as De Novo Second-line Treatment for Advanced Non-Small Cell Lung Cancer: CheckMate 907

Abstract

After the initial approval of weight-based nivolumab dosing used in registrational studies for second-line advanced/metastatic non-small cell lung cancer (NSCLC), flat doses of 240 mg Q2W and 480 mg Q4W were approved in multiple countries based on pharmacokinetic modeling and clinical safety data. The clinical safety data were across multiple tumor types in patients who switched from 3 mg/kg Q2W to 480 mg Q4W nivolumab dosing, and demonstrated similar safety profiles for the two regimens. Here, we report on CheckMate 907 (NCT03090737), the first phase 2 safety study to evaluate de novo administration of nivolumab 480 mg Q4W as second-line treatment in immunotherapy-naïve patients with advanced/metastatic NSCLC.