Nintedanib Plus Docetaxel After Progression on Immune Checkpoint Inhibitor Therapy: Insights from VARGADO, A Prospective Study in Patients with Lung Adenocarcinoma

Abstract

<b>Aim:</b> To assess outcomes in patients with advanced adenocarcinoma non-small-cell lung cancer who received nintedanib plus docetaxel after progression on prior chemotherapy followed by immune checkpoint inhibitor (ICI) therapy. <b>Patients & methods:</b> VARGADO is a prospective, noninterventional study. We describe initial data from a cohort of 22 patients who received nintedanib plus docetaxel after chemotherapy and ICI therapy. <b>Results:</b> Median progression-free survival with nintedanib plus docetaxel was 5.5 months (95% CI: 1.9-8.7 months). The objective response rate was 7/12 (58%) and the disease control rate was 10/12 (83%). Data for overall survival rate 12 months after the start of treatment (primary end point) are not yet mature and are not reported. Of 22 patients, 73% experienced drug-related adverse events; adverse events led to treatment discontinuation in 32% of patients. <b>Conclusion:</b> These data highlight the potential clinical benefit of nintedanib plus docetaxel in patients who failed prior ICI therapy. <b>Trial registration number:</b> NCT02392455.