Nivolumab plus anlotinib hydrochloride in advanced gastric adenocarcinoma and esophageal squamous cell carcinoma: the phase II OASIS trial

Jing Wu, Shilong Zhang, Shan Yu, Guo An, Yi Wang, Yiyi Yu, Li Liang, Yan Wang, Xiaojing Xu, YanShi Xiong, Di Shao, Zhun Shi, Nannan Li, Jingyuan Wang, Dawei Jin (), Tianshu Liu () and Yuehong Cui ()
Additional contact information
Jing Wu: Fudan University
Shilong Zhang: Fudan University
Shan Yu: Fudan University
Guo An: BGI Genomics
Yi Wang: Fudan University
Yiyi Yu: Fudan University
Li Liang: Fudan University
Yan Wang: Fudan University
Xiaojing Xu: Fudan University
YanShi Xiong: BGI Genomics
Di Shao: BGI Genomics
Zhun Shi: BGI Research
Nannan Li: BGI Genomics
Jingyuan Wang: Fudan University
Dawei Jin: BGI Genomics
Tianshu Liu: Fudan University
Yuehong Cui: Fudan University

Nature Communications, 2024, vol. 15, issue 1, 1-15

Abstract: Abstract Vascular endothelial growth factor inhibitors, including tyrosine kinase inhibitors (TKIs), possess immunomodulatory properties and have shown promising outcomes when combined with anti-PD-1 antibodies. The OASIS phase II trial (NCT04503967) is designed to determine the clinical activity and safety of nivolumab (anti-PD-1) and anlotinib hydrochloride (a multi-targets TKI) as second-line or above therapy in patients with advanced gastric adenocarcinoma (GAC) and esophageal squamous cell carcinoma (ESCC). From December 2020 to September 2022, 45 patients with GAC and 3 with ESCC were enrolled in this study. The pre-specified endpoints were reached, with the primary endpoint of overall response rate achieving 29.2%. For secondary objectives, disease control rate was 64.6%; median progression-free survival was 4.0 months; and median overall survival was 11.1 months with a manageable toxicity profile. The exploratory analyses unveiled that the balance of gut bacteria and the presence of a pre-existing immune signature characterized by a high percentage of CD68+PD-L1+ PD-1+ macrophages and low pretreatment variant allele frequencies (VAF), as well as low expression of certain cytokines were significantly associated with improved clinical outcomes in patients with GAC.

Date: 2024
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DOI: 10.1038/s41467-024-53109-4

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