# US 2013/0157893 A1 · Method for predicting therapeutic effect of immunotherapy on cancer patient, and gene set and kit to be used in the method

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- Number: US 2013/0157893 A1
- Document ID: US20130157893A1
- Status: Published application
- Kind: A1
- Application number: 13/807,418
- Filed: 2011-03-30
- Published: 2013-06-20
- Earliest claimed: 2010-06-29
- Inventors: Kyogo Itoh; Masanori Noguchi; Satoru Kuhara; Akira Yamada; Shigeki Shichijo; Nobukazu Komatsu; Kosuke Tashiro
- Web page: https://patentgrep.com/patent/US20130157893A1

## CPC

- C12Q 1/6837: using probe arrays or probe chips (C12Q1/6874 takes precedence)
- C12Q 1/686: Polymerase chain reaction [PCR]
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/575: for cancer
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/158: Expression markers
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Provided is a gene set which is useful for predicting the therapeutic effect of an immunotherapy on a cancer patient. Also provided is a method for examining whether an immunotherapy is efficacious or not, said method comprising quantifying the expression amount of each of the genes constituting the aforesaid gene set. This examination method is useful for determining a therapeutic strategy for the cancer patient.

## Claims

### Claim 1

A method for predicting effect of immunotherapy on a cancer patient, comprising a step of measuring an expression level of each of at least one gene selected from the group of genes shown in Table 1, 19, 34 or 35 in a sample obtained from the cancer patient before the immunotherapy.

### Claim 2 (depends on 1)

The method according to claim 1, wherein an expression level of each of LOC653600, TNFRSF19, P4HA1 and SYNE1 is measured.

### Claim 3

(canceled)

### Claim 4 (depends on 1)

The method according to claim 1, wherein an expression level of each of DEFA1, DEFA4, CEACAM8 and MPO is measured.

### Claim 5

(canceled)

### Claim 6 (depends on 1)

The method according to claim 1, wherein an expression level of each of LRRN3, PCDH17, HIST1H4C and PGLYRP1 is measured.

### Claim 7 (depends on 1)

The method according to claim 1, further comprising a step of determining a prognosis of the patient by discriminant analysis using the expression level.

### Claim 8 (depends on 1)

The method according to claim 1, for predicting a poor prognosis group.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the immunotherapy is peptide vaccine therapy.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the cancer is prostate cancer.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the sample obtained from the cancer patient is blood.

### Claim 12

A gene set for predicting effect of immunotherapy on a cancer patient, comprising at least one gene selected from the group of genes shown in Table 1, 19, 34 or 35.

### Claim 13 (depends on 12)

The gene set according to claim 12, wherein the gene set comprises at least one gene selected from the group of genes shown in Table 2 or 22.

### Claim 14 (depends on 12)

The gene set according to claim 12, wherein the gene set comprises LOC653600, TNFRSF19, P4HA1 and SYNE1.

### Claim 15 (depends on 12)

The gene set according to claim 12, wherein the gene set comprises DEFA1, DEFA4, CEACAM8 and MPO.

### Claim 16 (depends on 12)

The gene set according to claim 12, wherein the gene set comprises LRRN3, PCDH17, HIST1H4C and PGLYRP1.

### Claim 17 (depends on 12)

A biomarker for predicting effect of immunotherapy on a cancer patient, consisting of a gene set according to claim 12.

### Claim at position 18

18-20. (canceled)

### Claim 21 (depends on 1)

The method according to claim 1, further comprising a step of measuring an expression level of IL-6 protein in blood obtained from the cancer patient before the immunotherapy.