Nivolumab plus anlotinib hydrochloride in advanced gastric adenocarcinoma and esophageal squamous cell carcinoma: the phase II OASIS trial.
Nat Commun, 2024/10/15;15(1):8876.
Wu J[1, 2, 3], Zhang S[1, 2], Yu S[1, 2], An G[4, 5], Wang Y[6], Yu Y[1, 2], Liang L[1, 2], Wang Y[1, 2], Xu X[1, 2], Xiong Y[4, 5], Shao D[4], Shi Z[7], Li N[4, 7, 8], Wang J[1, 2], Jin D[9, 10], Liu T[11, 12], Cui Y[13, 14]
Affiliations
PMID: 39406730DOI: 10.1038/s41467-024-53109-4
Impact factor: 17.694
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.
MeSH terms
Humans; Nivolumab; Male; Quinolines; Female; Middle Aged; Aged; Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms; Stomach Neoplasms; Indoles; Adenocarcinoma; Adult; Antineoplastic Combined Chemotherapy Protocols; Programmed Cell Death 1 Receptor; B7-H1 Antigen; Progression-Free Survival; Aged, 80 and over
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