Real-World Efficacy of Nintedanib Plus Docetaxel After Progression on Immune Checkpoint Inhibitors: Results From the Ongoing, Non-interventional VARGADO Study. Issue 7 (July 2022)

• Record Type: Journal Article
• Authors: Grohé, C.; Blau, W.; Gleiber, W.; Haas, S.; Hammerschmidt, S.; Krüger, S.; Müller-Huesmann, H.; Schulze, M.; Wehler, T.; Atz, J.; Kaiser, R.
• Is Part Of: Clinical oncology. Volume 34:Issue 7(2022)
• Page Start: 459
• Page End: 468
• Publication Date: 2022-07
• Subjects: Advanced non-small cell lung cancer (nsclc) -- anti-angiogenic therapy -- angio-immunogenic switch -- fast-progressing -- immune checkpoint inhibitor (ici) resistance -- real-world evidence; Oncology -- Periodicals; Tumors -- Periodicals; Cancer -- Treatment -- Periodicals; Radiotherapy -- Periodicals; Neoplasms -- Periodicals; Cancer -- Radiotherapy; Cancer -- Treatment; Oncology; Medical radiology; Radiotherapy; Tumors; Electronic journals; Periodicals; 616.994
• DOI: 10.1016/j.clon.2021.12.010
• Languages: English
• ISSNs: 0936-6555

Abstract

Abstract: Aims: To evaluate the efficacy and safety of nintedanib plus docetaxel in patients with advanced adenocarcinoma non-small cell lung cancer (NSCLC) who progressed after chemotherapy and immune checkpoint inhibitor (ICI) therapy. Materials and methods: VARGADO (NCT02392455) is an ongoing, prospective, non-interventional, real-world study of nintedanib plus docetaxel after first-line chemotherapy in the routine clinical treatment of patients with locally advanced, metastatic or locally recurrent adenocarcinoma NSCLC. Data were collected during routine visits. We report the results from cohort B ( n = 80), who received third-line nintedanib plus docetaxel after first-line chemotherapy and second-line ICI therapy. Results: The median duration of follow-up was 12.4 months. Median progression-free survival from initiation of third-line nintedanib plus docetaxel was 6.4 months (95% confidence interval 4.8, 7.3); median overall survival was 12.1 months (95% confidence interval 9.4, 13.5). The 1-year overall survival rate after initiation of third-line nintedanib plus docetaxel treatment (primary end point) was 52% (95% confidence interval 38.0%, 64.4%). Among 64 patients with a documented response, the objective response rate was 50% ( n = 32; one complete response and 31 partial responses) and the disease control rate was 86% ( n = 55). There were no new safety signals or unexpected toxicities. Among all treated patients, 74% ( n = 59) experienced drug-related adverse events, most commonly (nintedanib-related/docetaxel-related) diarrhoea (34%/24%), a decreased white blood cell count (11%/19%) and nausea (13%/16%). Conclusions: Nintedanib plus docetaxel demonstrated a high response rate and disease stabilisation in the third-line setting after failure of prior chemotherapy and ICI treatment, with a manageable safety profile. These results suggest that nintedanib plus docetaxel represents an efficient treatment option after failure of prior ICIs. The ongoing VARGADO study provides valuable real-world data to inform clinical decision-making regarding treatment sequencing after chemotherapy and ICI failure in patients with adenocarcinoma NSCLC. Highlights: Limited clinical data are available to guide treatment decisions after ICI failure in patients with NSCLC. VARGADO cohort B included patients with adenocarcinoma NSCLC after failure of chemotherapy and ICI. Nintedanib plus docetaxel showed real-world efficacy after failure of prior ICIs. Median PFS and overall survival were 6.4 and 12.1 months; 1-year overall survival rate was 52% and DCR was 86%. 74% of patients reported treatment-related adverse events, with diarrhoea being the most common.