Claims for Patent: 10,501,523

Summary for Patent: 10,501,523

Title:	IL-8 level based method of predicting the outcome of colon cancer treatment
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.
Inventor(s):	Chiron-Blondel; Marielle (Paris, FR), Lambrechts; Diether (Leuven, BE), Magherini; Emmanuelle (Ris Orangis, FR), Thuillier; Vincent (Bures sur Yvette, FR)
Assignee:	SANOFI (Paris, FR)
Application Number:	15/408,827
Patent Claims:	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/m.sup.2-600 mg/m.sup.2 folinic acid, 2000 mg/m.sup.2-4000 mg/m.sup.25-fluorouracil (5-FU) and either 85 mg/m.sup.2 oxaliplatin or 100 mg/m.sup.2-300 mg/m.sup.2 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. 2. The method according to claim 1, wherein the reference level of IL-8 is between 10 and 30 pg/ml. 3. The method according to claim 1, wherein the reference level of IL-8 is 19 pg/ml. 4. The method according to claim 1, wherein the biological sample is selected from the group consisting of blood, serum, and plasma. 5. The method according to claim 1, wherein the colorectal cancer is a metastatic colorectal cancer. 6. The method according to claim 1, wherein the IL-8 level is a circulating level. 7. The method according to claim 1, wherein said patient has previously been treated with oxaliplatin or bevacizumab. 8. The method according to claim 1, wherein folinic acid is administered at a dosage of about 400 mg/m.sup.2, 5-FU is administered at a dosage of about 2800 mg/m.sup.2, irinotecan is administered at a dosage of about 180 mg/m.sup.2, and aflibercept at a dosage of about 4 mg/kg. 9. The method according to claim 8, wherein oxaliplatin, folinic acid, 5-FU, irinotecan, and aflibercept are administered every two weeks. 10. 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.

Details for Patent 10,501,523

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2034-07-18
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	11/18/2011		2034-07-18
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	08/16/2018		2034-07-18
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418	08/03/2012		2034-07-18