The following article features coverage from the ASCO Gastrointestinal Cancers Symposium 2022. Click here to read more of Cancer Therapy Advisor’s conference coverage.

Researchers say they have identified host-related biomarkers that might predict toxicities associated with nivolumab treatment in patients with advanced gastric cancer.

The researchers found that Arthrobacter bacteria and fatty acid metabolism pathways in the gut microbiome were associated with nivolumab-induced skin toxicity. In addition, the team identified single nucleotide polymorphisms (SNPs) that were associated with skin and gastrointestinal adverse events (AEs).

These results, from the DELIVER trial, were presented at the ASCO Gastrointestinal Cancers Symposium 2022.

Continue Reading

The trial included 501 patients with advanced gastric cancer who were treated with nivolumab alone from March 2018 to August 2019. The researchers analyzed genomic data in fecal samples and SNPs in blood samples.

There were 487 patients with genomic and safety data. The data cutoff was about 1 year after the last patient was enrolled. AEs included diarrhea (n=87), skin eruptions (n=44), hypothyroidism (n=29), and adrenal disorders (n=11).

For the gut microbiome analysis, the researchers divided patients into a training cohort of 180 evaluable patients and a validation cohort of 257 evaluable patients. Results showed that Arthrobacter bacteria and fatty acid metabolism pathways were significantly associated with skin AEs in the training cohort (P =.021 and P =.024, respectively), and this was confirmed in the validation cohort (P =.011 for both).

The SNP analysis included data from 440 patients. The results showed a significant association between skin AEs and SNPs in NLRC5 and IL6R. SNPs in NOTCH1 and SEMA4D were significantly associated with diarrhea.

The researchers plan to perform further analyses using updated clinical and toxicity data. They are currently evaluating the relationship between genomic pathways in the gut microbiome and the efficacy of nivolumab as well.

Disclosures: This research is supported by Ono Pharmaceutical and Bristol-Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Read more of Cancer Therapy Advisor’s coverage of ASCO GI 2022 by visiting the conference page.


Sunakawa Y, Matoba R, Takayama T, et al. Host-related biomarkers including gut microbiome to predict toxicities of nivolumab in advanced gastric cancer: DELIVER trial (JACCRO GC-08). Presented at ASCO GI 2022. January 20-22, 2022; Abstract 245.