Christian Grohé1, Wolfgang Gleiber2, Siegfried Haas3, Christoph Losem4, Harald Mueller-Huesmann5, Mathias Schulze6, Christian Franke7, Nadezda Basara8, Judith Atz9, Rolf Kaiser10,11. 1. Department of Respiratory Diseases, ELK, 13125, Berlin, Germany. 2. University Hospital Frankfurt, Pneumology/Allergology, 60590 Frankfurt, Germany. 3. Friedrich-Ebert Hospital Neumuenster, Clinics for Hematology, Oncology & Nephrology, 24534 Neumuenster, Germany. 4. MVZ für Onkologie und Hämatologie im Rhein-Kreis Neuss, 41462 Neuss, Germany. 5. Klinik für Hämatologie und Onkologie, Bruederkrankenhaus St Josef, 33098 Paderborn, Germany. 6. Praxis Dr Schulze, 02763 Zittau, Germany. 7. Facharztzentrum Sonneberg, 96515 Sonneberg, Germany. 8. Department of Internal Medicine, Malteser Hospital, St Franziskus, 24939 Flensburg, Germany. 9. Medical Affairs Oncology, Boehringer Ingelheim Pharma GmbH & Co KG, 55216 Ingelheim Am Rhein, Germany. 10. Boehringer Ingelheim Pharma GmbH & Co, KG, 55216 Ingelheim Am Rhein, Germany. 11. Institute of Pharmacology, Johannes Gutenberg-University Mainz, 55122 Mainz, Germany.
Abstract
Aim: 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. Patients & methods: 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. Results: 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. Conclusion: These data highlight the potential clinical benefit of nintedanib plus docetaxel in patients who failed prior ICI therapy. Trial registration number: NCT02392455.
Aim: 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. Patients & methods: 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. Results: 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. Conclusion: These data highlight the potential clinical benefit of nintedanib plus docetaxel in patients who failed prior ICI therapy. Trial registration number: NCT02392455.