Gastrointestinal Cancers Symposium

Gastrointestinal Cancers Symposium

Perspective from Ajay Goel, PhD, AGAF
Source:

Sunakawa Y, et al. Abstract 161. Presented at: Gastrointestinal Cancers Symposium (virtual meeting); Jan. 15-17, 2021.

Disclosures: Bristol Myers Squibb and Ono Pharmaceuticals funded this study. Sunakawa reports consultant/advisory roles with Bristol Myers Squibb Japan, Daiichi Sankyo and Takeda; honoraria from Bayer Yakuhin, Bristol Myers Squibb Japan, Chugai Pharma, Eli Lilly Japan, Kyowa Hakko Kirin, Nippon Kayaku, Sanofi, Taiho Pharmaceutical, Takeda and Yakult Honsha; and research funding from Chugai Pharma, Daiichi Sankyo; Eli Lilly Japan, Sanofi, Taiho Pharmaceutical and Takeda. Please see the abstract for all other researchers’ relevant financial disclosures.
January 21, 2021
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Gut microbiome a potential biomarker for nivolumab efficacy in advanced gastric cancer

Perspective from Ajay Goel, PhD, AGAF
Source:

Sunakawa Y, et al. Abstract 161. Presented at: Gastrointestinal Cancers Symposium (virtual meeting); Jan. 15-17, 2021.

Disclosures: Bristol Myers Squibb and Ono Pharmaceuticals funded this study. Sunakawa reports consultant/advisory roles with Bristol Myers Squibb Japan, Daiichi Sankyo and Takeda; honoraria from Bayer Yakuhin, Bristol Myers Squibb Japan, Chugai Pharma, Eli Lilly Japan, Kyowa Hakko Kirin, Nippon Kayaku, Sanofi, Taiho Pharmaceutical, Takeda and Yakult Honsha; and research funding from Chugai Pharma, Daiichi Sankyo; Eli Lilly Japan, Sanofi, Taiho Pharmaceutical and Takeda. Please see the abstract for all other researchers’ relevant financial disclosures.
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The gut microbiome potentially could serve as a biomarker to predict the efficacy of nivolumab among patients with advanced gastric cancer, according to results of the DELIVER trial presented at Gastrointestinal Cancers Symposium.

Gastric cancer-specific gut microbiome additionally appeared to predict immune checkpoint inhibitor response, researchers noted.

The gut microbiome potentially could serve as a biomarker to predict the efficacy of nivolumab among patients with advanced gastric cancer.

“Previous research demonstrated a survival benefit of nivolumab [Opdivo, Bristol Myers Squibb] monotherapy among previously treated patients with advanced gastric cancer,” Yu Sunakawa, MD, PhD, associate professor in the department of clinical oncology at St. Marianna University School of Medicine in Japan, said during his virtual presentation. “However, many patients did not experience response to treatment. Therefore, predictive biomarkers are needed for nivolumab treatment in gastric cancer. We sought to investigate whether genomic information in gut microbiome will serve as predictors for nivolumab in advanced gastric cancer.”

The observational/translational, multicenter study enrolled 501 patients with advanced gastric cancer who received nivolumab between March 2018 and August 2019. Researchers identified gut microbiome biomarkers from fecal samples collected before treatment.

The relationship between the genomic pathway in the gut microbiome and the efficacy of nivolumab served as the primary endpoint. Various associations between gut microbiome markers and clinical outcomes served as secondary endpoints.

The statistical analysis included two steps. For the first step, researchers used the Wilcoxon rank sum test to assess biomarkers among the first 200 patients enrolled (training cohort). For the second step, they used the Bonferroni method to validate the top 30 potential biomarkers in the last 300 patients (validation cohort).

Overall, 180 patients (median age, 70 years; range, 37-90; 76% men) in the training cohort and 257 patients (median age, 71 years; range, 26-90; 72% men) in the validation cohort were available for evaluation.

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, according to Sunakawa.

The Bonferroni method yielded no statistically significant genomic pathways for validation as a primary endpoint. Researchers did, however, observe an association between bacterial invasion of epithelial cells in the KEGG pathway and clinical outcomes of nivolumab in the training cohort — which fell short of statistical significance — and in the validation cohort (P = .014). In addition, they found a relationship between upregulation of the KEGG pathway and progressive disease at first evaluation of nivolumab therapy.

Results of an exploratory analysis indicated that Odoribacter and Veillonella were associated with tumor response to nivolumab among patients in both cohorts.

“Ongoing biomarker analyses are looking at the relationships between the gut microbiome and survival time, as well as scoring by combining gut microbiome with metabolome data,” Sunakawa said.