Claims for Patent: 10,378,058

Summary for Patent: 10,378,058

Title:	Diagnostic and therapeutic methods and compositions involving PTEN and breast cancer
Abstract:	Patients with ErbB2-overexpressing cancers can be given an ErbB2 targeting agent as a therapeutic regimen but not all patients are responsive. The present invention concerns the diagnostic, prognostic and therapeutic methods and compositions for evaluating potential efficacy of an ErbB2 targeting agent in an ErbB2-overexpressing cancers by evaluating PTEN expression, which is predictive of responsiveness or resistance to ErbB2 targeting agents such as trastuzumab. Low PTEN expression is predictive of a patient who will respond poorly to trastuzumab.
Inventor(s):	Yu; Dihua (Houston, TX), Zhou; Xiaoyan (Shanghai, CN), Nagata; Yoichi (Tosu, JP), Esteva; Francisco J. (Bellaire, TX), Sahin; Aysegul A. (Houston, TX)
Assignee:	Board of Regents of The University of Texas System (Austin, TX)
Application Number:	12/943,644
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,378,058
Patent Claims:	1. A method for administering a treatment regimen comprising an effective amount of a P13K inhibitor, said method comprising: (1) assaying a patient sample comprising at least one test cancer cell to measure the amount of PTEN protein having the amino acid sequence of SEQ ID NO:2 using at least one technique chosen from the group consisting of immunohistochemistry, immunoprecipitation, enzyme linked immunosorbent assay (ELISA), radioimmunoassay (RIA), immunoradiometric assay, fluoroimmunoassay, chemiluminescent assay, bioluminescent assay, western blot, antibody array, and FACS analysis; (2) comparing the amount of PTEN protein measured in (1) to a reference amount of PTEN protein in reference cancer cells of a reference cohort of patients who are not candidates for said treatment regimen; and (3) administering said treatment regimen to a test patient for whom said at least one test cancer cell is measured in (1) to have an absence of detectable PTEN protein or an amount of PTEN protein that is no more than 50% of said reference amount of PTEN protein in (2). 2. The method of claim 1, wherein said at least one test cancer cell is selected from the group consisting of breast cancer cells, lung cancer cells, ovarian cancer cells, brain cancer cells, gastrointestinal tract cancer cells, salivary duct cancer cells, endometrial cancer cells, prostate cancer cells, head & neck cancer cells, glioma cells, pancreatic cancer cells, hepatocellular cancer cells, myeloma cells, soft tissue sarcoma cells, and non-small cell lung cancer cells. 3. The method of claim 1, wherein said treatment regimen is administered to a test patient for whom said at least one test cancer cell is measured in (1) to have an absence of detectable PTEN protein or an amount of PTEN protein that is no more than 80% of said reference amount of PTEN protein in (2). 4. A method for administering a first treatment regimen comprising an effective amount of a PI3K inhibitor, said method comprising: (1) assaying a patient sample comprising at least one test cancer cell to measure the amount of PTEN protein having the amino acid sequence of SEQ ID NO:2 using at least one technique chosen from the group consisting of immunohistochemistry, immunoprecipitation, enzyme linked immunosorbent assay (ELISA), radioimmunoassay (RIA), immunoradiometric assay, fluoroimmunoassay, chemiluminescent assay, bioluminescent assay, western blot, antibody array, and FACS analysis; (2) comparing the amount of PTEN protein measured in (1) to a reference amount of PTEN protein in reference cancer cells of a reference cohort of patients who are not candidates for said first treatment regimen; and (3) (a) administering said first treatment regimen to a test patient for whom said at least one test cancer cell is measured in (1) to have an absence of detectable PTEN protein or an amount of PTEN protein that is no more than 50% of said reference amount of PTEN protein in (2); or (3) (b) administering a second treatment regimen comprising trastuzumab to a test patient for whom said at least one test cancer cell is measured in (1) to have an amount of PTEN protein that is greater than 50% of said reference amount of PTEN protein in (2). 5. The method of claim 4, wherein said at least one test cancer cell is selected from the group consisting of breast cancer cells, lung cancer cells, ovarian cancer cells, brain cancer cells, gastrointestinal tract cancer cells, salivary duct cancer cells, endometrial cancer cells, prostate cancer cells, head & neck cancer cells, glioma cells, pancreatic cancer cells, hepatocellular cancer cells, myeloma cells, soft tissue sarcoma cells, and non-small cell lung cancer cells. 6. The method of claim 4, wherein in (3)(a) said first treatment regimen is administered to a test patient for whom said at least one test cancer cell is measured in (1) to have an absence of detectable PTEN protein or an amount of PTEN protein that is no more than 80% of said reference amount of PTEN protein in (2); and in (3)(b) said second treatment regimen is administered to a test patient for whom said at least one test cancer cell is measured in (1) to have an amount of PTEN protein that is greater than 80% of said reference amount of PTEN protein in (2).

Details for Patent 10,378,058

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2023-11-05
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2023-11-05
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2023-11-05