https://scholars.lib.ntu.edu.tw/handle/123456789/557692
Title: | Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial | Authors: | Park K. ?zg?ro?lu, Mustafa Vansteenkiste J. Spigel D. CHIH-HSIN YANG Bajars M. Ruisi M. Manitz J. Barlesi F. |
Keywords: | Clinical trial; Immunotherapy; Lung neoplasm; Phase III as topic; Programmed cell death 1 ligand 1 | Issue Date: | 2021 | Publisher: | Elsevier Ireland Ltd | Journal Volume: | 154 | Start page/Pages: | 92-98 | Source: | Lung Cancer | Abstract: | Objectives: The JAVELIN Lung 200 phase 3 trial did not meet its primary endpoint of improving overall survival (OS) with avelumab vs docetaxel in patients with platinum-treated PD-L1+ NSCLC. We report post hoc analyses assessing the effects of subsequent immune checkpoint inhibitor (ICI) treatment on OS. Material and methods: Patients with stage IIIB/IV NSCLC progressed following platinum-doublet therapy were randomized to receive avelumab or docetaxel. OS was analyzed in the PD-L1+ population (?1% of tumor cells) and full analysis set (PD-L1+ or PD-L1?). Effects of subsequent ICI (after permanent discontinuation of study treatment) on OS were analyzed using a preplanned naive sensitivity analysis and post hoc inverse probability of censoring weighting (IPCW) analysis. Subgroups with or without subsequent ICI treatment were analyzed using descriptive statistics. Results: In the avelumab and docetaxel arms, a subsequent ICI was received by 16/396 (4.0 %) and 104/396 (26.3 %) after a median of 10.5 months (range, 3.9–20.4) and 5.7 months (range, 0.1–24.4), respectively. Some subgroups showed trends for higher subsequent ICI treatment, including patients with non-squamous NSCLC (avelumab arm, 4.3 % vs docetaxel arm, 32.1 %) or with a baseline ECOG performance status of 0 (6.3 % vs 31.3 %); those enrolled in the early recruitment wave (11.6 % vs 54.3 %), or enrolled in the US/Western Europe (2.8 % vs 45.5 %) or Asia (11.0 % vs 35.4 %); and non-white patients (10.1 % vs 35.0 %). The hazard ratio for OS with avelumab vs docetaxel was lower in the IPCW analysis than in the naive sensitivity analysis (PD-L1+ population: 0.80 [95 % CI, 0.62?1.04] vs 0.86 [95 % CI, 0.68?1.09], respectively). Conclusion: In the JAVELIN Lung 200 trial, avelumab showed clinical activity as second-line treatment for patients with advanced NSCLC. Post hoc analyses suggest that the primary OS analysis may have been confounded by subsequent ICI use in the docetaxel arm. ClinicalTrials.gov identifier: NCT02395172. ? 2021 Elsevier B.V. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85101358388&doi=10.1016%2fj.lungcan.2021.01.026&partnerID=40&md5=f7ab49708587f486abd79ab6614ac54c https://scholars.lib.ntu.edu.tw/handle/123456789/557692 |
ISSN: | 0169-5002 | DOI: | 10.1016/j.lungcan.2021.01.026 | SDG/Keyword: | avelumab; bintrafusp alfa; cemiplimab; docetaxel; durvalumab; immune checkpoint inhibitor; nivolumab; pembrolizumab; platinum; programmed death 1 ligand 1; programmed death 1 receptor; ticilimumab; tislelizumab; avelumab; docetaxel; monoclonal antibody; platinum; advanced cancer; Article; Asia; cancer cell; cancer immunotherapy; cancer patient; cancer staging; cancer survival; Caucasian; cell population; controlled study; drug effect; ECOG Performance Status; female; human; human tissue; major clinical study; male; multicenter study; non small cell lung cancer; open study; overall survival; phase 3 clinical trial; post hoc analysis; probability; randomized controlled trial; sensitivity analysis; United States; Western Europe; Europe; lung; lung tumor; Antibodies, Monoclonal, Humanized; Asia; Docetaxel; Europe; Humans; Immune Checkpoint Inhibitors; Lung; Lung Neoplasms; Platinum [SDGs]SDG3 |
Appears in Collections: | 腫瘤醫學研究所 |
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