Claims for Patent: 8,273,534

Summary for Patent: 8,273,534

Title:	Predictors of patient response to treatment with EGF receptor inhibitors
Abstract:	The present invention provides methods and compositions to facilitate determining whether an EGFR-expressing cancer in an individual is an EGFR inhibitor-responsive cancer, as well as methods for determining the likelihood that a patient having an EGFR-expressing cancer will exhibit a beneficial response to an EGFR inhibitor therapy. The methods generally involve determining a normalized expression level of a gene product that correlates with EGFR inhibitor responsiveness.
Inventor(s):	Baker; Joffre B. (Montara, CA), Watson; Drew (Los Altos, CA), Maddala; Tara (Redwood City, CA), Shak; Steven (Hillsborough, CA), Mauro; David J. (Redwood City, CA), Ford; Shirin K. (Redwood City, CA)
Assignee:	Genomic Health, Inc. (Redwood City, CA) Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:	12/465,503
Patent Claims:	1. A method for predicting a likelihood that a human patient with an epidermal growth factor receptor (EGFR)--expressing colorectal cancer will exhibit a beneficial response to an EGFR inhibitor comprising: (a) measuring, in a tumor sample obtained from the patient, a level of an RNA transcript, or its expression product, for each of solute carrier family 26, member 3 (SLC26A3), amphiregulin (AREG), epiregulin (EREG) and dual specificity phosphatase 6 (DUSP6), (b) normalizing the level of the RNA transcript, or its expression product, for each of SLC26A3, AREG, EREG, and DUSP6 to obtain a normalized expression level for each of SLC26A3, AREG, EREG, and DUSP6; and (c) using the normalized expression level to determine the likelihood that the patient will exhibit a beneficial response to an EGFR inhibitor, wherein the normalized expression levels of SLC26A3, AREG, and EREG are positively correlated with the likelihood that the patient will exhibit a beneficial response to the EGFR inhibitor, and wherein the normalized expression level of DUSP6 is negatively correlated with the likelihood that the patient will exhibit a beneficial response to the EGFR inhibitor. 2. The method of claim 1, wherein the tumor sample is obtained from a tissue biopsy. 3. The method of claim 1, wherein the EGFR inhibitor is an antibody specific for EGFR. 4. The method of claim 3, wherein the EGFR inhibitor is cetuximab. 5. The method of claim 1, wherein the EGFR inhibitor is a small molecule. 6. The method of claim 5, wherein the small molecule is an EGFR-selective tyrosine kinase inhibitor. 7. The method of claim 1, wherein the normalized expression level is determined relative to an expression level of at least one reference gene. 8. The method of claim 1, wherein the levels of the SLC26A3, AREG, EREG, and DUSP6 RNA transcripts are measured. 9. The method of claim 8, wherein the levels of the SLC26A3, AREG, EREG, and DUSP6 RNA transcripts are measured by reverse transcriptase polymerase chain reaction (RT-PCR). 10. The method of claim 1, wherein beneficial response is expressed in terms of Overall Response Rate (ORR) or Disease Control (DC). 11. The method of claim 1, wherein the normalized expression level is weighted by its contribution to response to the EGFR inhibitor. 12. The method of claim 1, further comprising the step of creating a report summarizing said prediction.

Details for Patent 8,273,534

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2028-05-14
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2028-05-14