Methods for predicting responses to immune checkpoint inhibitors

Abstract

Provided is a method for predicting a response to an immune checkpoint inhibitor for a subject having cancer, the method comprising: a step (1) for determining one or more values or the presence or the absence of single nucleotide polymorphism (SNP), selected from the group consisting of: (i) abundance of microorganisms in feces or bowel content of the subject, (ii) genome pathway score in feces or bowel content of the subject, (iii) abundance of metabolic products in the blood, serum, or plasma of the subject, (iv) gene expression in the blood, serum or plasma of the subject, and (v) SNP of one or more genes selected from the group consisting of IL6R and NLRC5 of the subject; and a step (2) for predicting a response of the subject to an immune checkpoint inhibitor on the basis of the value obtained in the step (1).

Claims

1. A method for providing information to predict the response to immune checkpoint inhibitors in subjects with gastric cancer, (1) Below: (i) The amount of microorganisms present in the feces or intestinal contents of the subject. Steps to determine the value, (2) A step of providing information for predicting the response of the subject to an immune checkpoint inhibitor, using the value obtained in step (1) as an indicator. Includes, The microorganism is one or more microorganisms selected from the group consisting of the genera Geobacillus, Gordonibacter, Odoribacter, Veillonella, and Arthrobacter. A method wherein the immune checkpoint inhibitor is an anti-PD-1 antibody.

2. The microorganism is one or more microorganisms selected from the group consisting of the genera Geobacillus, Gordonibacter, Odoribacter, and Veillonella. If the abundance of microorganisms of the genus Geobacillus, the genus Gordonibacter, and / or the genus Veillonella is higher than a predetermined threshold, and / or The method according to claim 1, wherein if the abundance of microorganisms of the genus Odoribacter is lower than a predetermined threshold, information is provided for predicting that the target will respond well to an immune checkpoint inhibitor.

3. The microorganism is one or more microorganisms selected from the group consisting of the genera Veillonella and Odoribacter. If the abundance of microorganisms of the genus Veillonella is higher than a predetermined threshold, and / or, The method according to claim 1, wherein if the abundance of microorganisms of the genus Odoribacter is lower than a predetermined threshold, information is provided for predicting that the target will respond well to an immune checkpoint inhibitor.

4. The microorganism is one or more microorganisms selected from the group consisting of the genera Geobacillus, Gordonibacter, Odoribacter, and Veillonella. When the abundance of microorganisms of the genus Geobacillus, the genus Gordonibacter, and / or the genus Veillonella is lower than a predetermined threshold, and / or The method according to claim 1, wherein if the abundance of microorganisms of the genus Odoribacter is higher than a predetermined threshold, information is provided for predicting that the response to an immune checkpoint inhibitor in the subject is poor.

5. The microorganism is one or more microorganisms selected from the group consisting of the genera Veillonella and Odoribacter. If the abundance of microorganisms of the genus Veillonella is lower than a predetermined threshold, and / or, The method according to claim 1, wherein if the abundance of microorganisms of the genus Odoribacter is higher than a predetermined threshold, information is provided for predicting that the response to an immune checkpoint inhibitor in the subject is poor.

6. The aforementioned microorganism belongs to the genus Arthrobacter. The method according to claim 1, wherein if the abundance of microorganisms of the genus Arthrobacter is higher than a predetermined threshold, information is provided for predicting that an immune checkpoint inhibitor will induce adverse skin events in the subject.

7. The method according to any one of claims 1 to 6, wherein the abundance of the microorganism is determined by metagenomic analysis.

8. A cancer treatment agent containing the anti-PD-1 antibody, characterized in that it is administered to a gastric cancer patient who is determined to have a good response to the anti-PD-1 antibody by the method described in any one of claims 1 to 7.

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