Claims for Patent: 9,567,627

Summary for Patent: 9,567,627

Title:	Method for predicting the response to treatment with an HER2-blocking agent
Abstract:	The invention relates in particular to an in vitro or ex vivo method for predicting the response of a patient to treatment with at least one HER2-blocking agent, said method including the steps of: i) identifying the nucleotide at the rs3746083 polymorphic site, for at least one allele, in particular the two alleles of the gene coding the tristetraprolin protein, in a biological sample from said patient; and/or ii) determining the concentration of the tristetraprolin protein in a biological sample from said patient, wherein said patient is suffering from HER2-positive cancer.
Inventor(s):	Pages; Gilles (Monaco, MC)
Assignee:	UNIVERSITE DE NICE SOPHIA ANTIPOLIS (Nice, FR) CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE (CNRS) (Paris, FR)
Application Number:	14/125,155
Patent Claims:	1. An in vitro or ex vivo method for determining the response of a patient to treatment with trastuzumab and treating a patient determined to be responsive to treatment with trastuzumab, said method comprising the steps of: i) identifying (a) or (b) at a rs3746083 polymorphic site at position 367 in a nucleotide sequence of SEQ ID NO: 3 coding for a tristetraprolin protein in a biological sample from said patient: (a) heterozygosity (T/C) or homozygosity (T/T) indicating that said patient is determined to be not responsive to treatment with trastuzumab; (b) homozygosity (C/C) indicating that said patient is determined to be responsive to the treatment with trastuzumab; ii) determining the level of the tristetraprolin protein in a biological sample from said patient and comparing it with at least one reference value, wherein the level of the tristetraprolin protein in the biological sample is greater than or equal to a reference value, the patient is predicted to be responsive to the treatment with trastuzumab; and iii) administering trastuzumab to said patient being determined to be responsive to treatment with trastuzumab, wherein said patient is suffering from HER2-positive breast cancer. 2. An in vitro or ex vivo method of prognosis or diagnosis of HER2-positive breast cancer in a patient and treating a patient determined to have said cancer, comprising: i) identifying (a) or (b) at a rs3746083 polymorphic site at position 367 in a nucleotide sequence of SEQ ID NO: 3 coding for a tristetraprolin protein in a biological sample from said patient; (a) heterozygosity (T/C) or homozygosity (T/T) indicating that said patient is determined to be not responsive to treatment with trastuzumab, (b) homozygosity (C/C) indicating that said patient is determined to be responsive to the treatment with trastuzumab, and ii) administering trastuzumab to said patient being determined to have HER2-positive breast cancer. 3. The method according to claim 2, wherein the cancer is HER2-positive breast cancer with a poor prognosis.

Details for Patent 9,567,627

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2031-06-10
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2031-06-10
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2031-06-10