Prof. Yu Sunakawa (St Marianna University School of Medicine, Kanagawa, Japan) presented the analysis of the DELIVER trial (UMIN000030850) [1]. DELIVER addressed the need for predictive biomarkers to predict efficacy of nivolumab treatment in gastric cancer, by analysing the patientsā gut microbiome. The primary endpoint was a significant relationship between the genomic signature in the gut microbiome and the efficacy of nivolumab.
Patients (n=501) with advanced gastric cancer received nivolumab between March 2018 and August 2019. Microbiomes were assessed in 2 cohorts. Firstly, 180 patients were included in a training cohort (median age 70 years; 76% men) for full microbiome analysis. Consequently, the top 30 microbial species were selected and, subsequently, an additional 257 patients forming the validation cohort (median age 71 years, 72% men) were tested for those 30 species.
The study found that disease progression occurred in 62.2% (95% CI 54.7-69.3) of patients in the training cohort and 53.2% (95% CI 47-59.4) of patients in the validation cohort. Patients without disease progression had a more diverse gut microbiome than those with progressive disease. Upregulation of the KEGG metabolic pathway was linked to progressive disease. An exploratory analysis indicated that Odoribacter and Veillonella species were associated with tumour response to nivolumab among patients in both cohorts (P=0.014).
Dr Sunakawa concluded that larger, prospective studies are needed to gain further confidence in these findings. In addition, longer follow-up of these patients will reveal whether the therapeutic response led to any survival gain.
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