Claims for Patent: 9,873,916

Summary for Patent: 9,873,916

Title:	Method for predicting response to trastuzumab therapy in breast cancer patients
Abstract:	This invention relates to a composition and a method for prediction of a response to Trastuzumab therapy in a breast cancer patient, and more specifically, a composition, a kit, a DNA chip, and a method for predicting a response to Trastuzumab therapy by using polynucleotides each comprising a nucleotide sequence represented by any of SEQ ID NOs: 1 to 9, 11 to 19, and 21 to 23 in the Sequence Listing or a nucleotide sequence derived therefrom by substitution of u with t, mutants thereof, derivatives thereof, or fragments thereof comprising at least 16 continuous nucleotides, or a polynucleotide comprising a complementary sequence thereof, and using an increase or decrease in Her2 protein expression level as an indicator.
Inventor(s):	Myomoto; Akira (Kamakura, JP), Kozono; Satoko (Kamakura, JP), Sato; Fumiaki (Kyoto, JP), Toi; Masakazu (Kyoto, JP), Ueno; Takayuki (Kyoto, JP), Wang; Zhipeng (Kyoto, JP), Tsujimoto; Gozoh (Kyoto, JP), Shimizu; Kazuharu (Kyoto, JP)
Assignee:	TORAY INDUSTRIES, INC. (Tokyo, JP) KYOTO UNIVERSITY (Kyoto, JP)
Application Number:	14/113,776
Patent Claims:	1. A method for predicting response to Trastuzumab therapy in an HER 2 positive breast cancer patient and treating with Trastuzumab the same HER2 positive breast cancer patient, comprising: predicting response to Trastuzumab therapy by the following steps of: (i) measuring, by hybridization or RT-PCR analysis, expression levels of target nucleic acids let-7a of SEQ ID NO: 5 and miR-23a of SEQ ID NO: 23 in a breast cancer tissue sample from the breast cancer patient using two or more polynucleotides selected from the group consisting of the following (a) to (b): (a) polynucleotides each comprising a nucleotide sequence having 95% or higher identity with the nucleotide sequence of SEQ ID NOs: 5 or 23 or with a nucleotide sequence derived therefrom by substitution of u with t, or fragments thereof comprising at least 16 continuous nucleotides; and (b) polynucleotides each comprising a nucleotide sequence complementary to the nucleotide sequence having 95% or higher identity with the nucleotide sequence of SEQ ID NOs: 5 or 23 or with a nucleotide sequence derived therefrom by substitution of u with t, or fragments thereof comprising at least 16 continuous nucleotides; and (ii) assigning the expression levels determined by measurement in step (i) to a discriminant prepared by a support vector machine using expression levels of target nucleic acids let-7a of SEQ ID NO: 5 and miR-23a of SEQ ID NO: 23 in a plurality of breast cancer tissue samples from breast cancer patients who are known to respond to Trastuzumab therapy and in a plurality of samples from breast cancer patients who are known not to respond to Trastuzumab therapy, wherein the expression levels are measured using the two or more polynucleotides or fragments thereof as defined in the (a) to (b), thereby predicting the patient is responsive to Trastuzumab therapy; administering Trastuzumab in a therapeutically effective amount to the breast cancer patient with predicted Trastuzumab therapy response. 2. The method according to claim 1, wherein measuring, by hybridization or RT-PCR analysis, expression levels of target nucleic acids let-7a of SEQ ID NO: 5 and miR-23a of SEQ ID NO: 23 in a breast cancer tissue sample from the breast cancer patient comprises using a DNA chip comprising the two or more polynucleotides of the polynucleotides and/or fragments thereof as defined in (a) to (b) of claim 1.

Details for Patent 9,873,916

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2031-04-25
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2031-04-25
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2031-04-25