# US 10,501,523 B2 · IL-8 level based method of predicting the outcome of colon cancer treatment

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- Number: US 10,501,523 B2
- Document ID: US10501523B2
- Status: Granted
- Kind: B2
- Application number: 15/408,827
- Filed: 2017-01-18
- Published: 2017-05-04
- Granted: 2019-12-10
- Earliest claimed: 2014-07-18
- Assignees: Sanofi
- Applicants: Sanofi
- Inventors: Marielle Chiron-Blondel; Diether Lambrechts; Emmanuelle Magherini; Vincent Thuillier
- Web page: https://patentgrep.com/patent/US10501523B2

## CPC

- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- C07K 14/71: for growth factors; for growth regulators
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 31/282: Platinum compounds
- A61K 31/4745: condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48)
- A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61P 35/00: Antineoplastic agents
- A61P 35/04: specific for metastasis
- G01N 33/57535: of the large intestine, e.g. colon, rectum or anus
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- G01N 2333/5421: IL-8
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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

The present invention concerns the use of interleukin-8 (IL-8) as a biomarker for predicting the outcome of the treatment with aflibercept, or ziv-aflibercept of a patient suspected to suffer from a cancer.

## Claims

### Claim 1

A method for treating a patient with colon cancer, colorectal cancer or a rectal cancer with 1 mg/kg-10 mg/kg aflibercept, or ziv-aflibercept, 200 mg/m2-600 mg/m2 folinic acid, 2000 mg/m2-4000 mg/m25-fluorouracil (5-FU) and either 85 mg/m2 oxaliplatin or 100 mg/m2-300 mg/m2 irinotecan to the patient, wherein a biological sample obtained from the patient has an interleukin-8 (IL-8) level that is lower than a reference level of IL-8.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the reference level of IL-8 is between 10 and 30 pg/ml.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the reference level of IL-8 is 19 pg/ml.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the biological sample is selected from the group consisting of blood, serum, and plasma.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the colorectal cancer is a metastatic colorectal cancer.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the IL-8 level is a circulating level.

### Claim 7 (depends on 1)

The method according to claim 1, wherein said patient has previously been treated with oxaliplatin or bevacizumab.

### Claim 8 (depends on 1)

The method according to claim 1, wherein folinic acid is administered at a dosage of about 400 mg/m2, 5-FU is administered at a dosage of about 2800 mg/m2, irinotecan is administered at a dosage of about 180 mg/m2, and aflibercept at a dosage of about 4 mg/kg.

### Claim 9 (depends on 8)

The method according to claim 8, wherein oxaliplatin, folinic acid, 5-FU, irinotecan, and aflibercept are administered every two weeks.

### Claim 10 (depends on 8)

The method according to claim 8, wherein oxaliplatin, folinic acid, 5-FU, irinotecan and aflibercept are administered intravenously every two weeks for a period of between 9 and 18 weeks.