Gene and protein expression profiles associated with the therapeutic efficacy of EGFR-TK inhibitors

Inactive Publication Date: 2008-08-28
NUCLEA BIOMARKERS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006]The present invention provides gene and protein expression profiles and methods for using them to identify those patients who are likely to respond to treatment with compounds that inhibit the intracellular phosphorylation of tyrosine kinase (TK) associated with epidermal growth factor receptor (EGFR), including erlotinib and gefitinib (these patients are referred to as “responders”), as well as those patients who are not likely to benefit from such treatment (these patients are referred to as “non-respo

Problems solved by technology

Patients diagnosed with cancer are faced with costly and often painful treatment options.
These treatments may be ineffective in a subpopulation of patients, and as a result, these patients endure these treatments without little or no therapeutic benefit.
Some patients may react adversely to certain agents causing additional suffering and possibly death.
Ineffective treatment also is problematic because time is a key variable when treating cancer.
An agent may provide great therapeutic benefits if administered at an early stage of the disease; however, with the passage of time, the same agent may cease to be effective.
As with many chemotherapeutic agents, administration of these drugs often causes deleterious side effects for the patient, and some patients do not respond well, or respond at all, to the treatment.
Some patients thus undergo treatment with erlotinib or gefitinib and suffer the painful side effects only to later realize that the agent has not been therapeutically beneficial to their condition.
In addition to the unnecessary suffering, critical time is lost in determining an alternative treatment.

Method used

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Examples

Experimental program
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Effect test

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[0088]Clinical Studies

[0089]A multicenter clinical trial in the United States evaluated the tumor response rate of gefitinib (IRESSA®) at dosages of 250 and 500 mg / day in patients with advanced non-small cell lung cancer (NSCLC) whose disease had progressed after at least two prior chemotherapy regimens including a platinum drug and docetaxel. IRESSA® was taken once daily at approximately the same time each day.

[0090]Two hundred and sixteen patients received IRESSA®; 102 (47%) received a 250 mg dose and 114 (53%) received a 500 mg daily dose. Study patient demographics and disease characteristics are summarized in Table A.

TABLE AScope of studyPatient Sample NumbersTreatment102 Patients (47%)250 mg Iressa114 Patients (53%)500 mg Iressa142 PatientsPlatinum and docetaxel therapies142 PatientsPositive disease progression

[0091]Forty-one percent of the patients had received two prior treatment regimens, 33% had received three prior treatment regimens, and 25% had received four or more pri...

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Abstract

The present invention provides protein and gene expression profiles indicative of whether a patient afflicted with non-small cell lung cancer is likely to be responsive to treatment with a therapeutic compound that is a EGFR-TK inhibitor. By identifying such responsiveness, a treatment provider may determine in advance those patients who would benefit from such treatment, as well as identify alternative therapies for non-responders. The present invention further provide methods of using the gene and protein expression profiles, and assays for identifying the presence of a gene or protein expression profile in a patient sample.

Description

RELATED APPLICATIONS[0001]This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application Ser. No. 60 / 903,684 filed Feb. 27, 2007, the entirety of which is incorporated herein by reference.BACKGROUND OF THE INVENTION [0002]Patients diagnosed with cancer are faced with costly and often painful treatment options. These treatments may be ineffective in a subpopulation of patients, and as a result, these patients endure these treatments without little or no therapeutic benefit. Some patients may react adversely to certain agents causing additional suffering and possibly death.[0003]Ineffective treatment also is problematic because time is a key variable when treating cancer. A treatment provider has a far greater chance of containing and managing the disease if the cancer is diagnosed at an early stage and treated with a therapeutically effective agent. An agent may provide great therapeutic benefits if administered at an early stage of the disease; however, wit...

Claims

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Application Information

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IPC IPC(8): C12Q1/68G01N33/574C07H21/00
CPCC12Q1/6886C12Q2600/106G01N2333/71G01N33/57423C12Q2600/118
InventorMURACA, PATRICK J.
OwnerNUCLEA BIOMARKERS