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Biomarkers and methods for determining efficacy of anti-egfr antibodies in cancer therapy

An antibody and product technology, which can be used in biochemical equipment and methods, biological material analysis, and microbial determination/inspection, etc., and can solve problems such as suboptimal selection.

Active Publication Date: 2012-05-16
MERCK PATENT GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, rash appearance was chosen as a surrogate marker because it is not possible to identify cancer patients who generally do not respond to anti-EGFR antibody therapy long before the drug is administered to the patient, so this choice is not optimal

Method used

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  • Biomarkers and methods for determining efficacy of anti-egfr antibodies in cancer therapy
  • Biomarkers and methods for determining efficacy of anti-egfr antibodies in cancer therapy
  • Biomarkers and methods for determining efficacy of anti-egfr antibodies in cancer therapy

Examples

Experimental program
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Embodiment

[0125] Clinical research:

[0126] EMR62202-502 : This randomized study investigated dose escalation of cetuximab in patients (pts) with EGFR-expressing mCRC including treatment failure of irinotecan. Patients start 22 days after starting cetuximab (400 mg / m2 initial dose, followed by 250 mg / m2 / week [w]) and I (180 mg / m2q 2w) if they do not experience >1 grade (G) skin reactions, Any other >G2 cetuximab-related adverse events and intolerant to I were randomized. Randomized into standard cetuximab dose group (group A; 250 mg / m2 / w) or dose escalation group (group B; cetuximab dose increased at 50 mg / m2q 2w until >G2 toxicity, tumor response Or dose=500mg / m2). Patients not randomized (arm C) continued on the standard cetuximab dose. The primary endpoint was the effect of dose escalation on EGFR and downstream signaling markers compared with the standard cetuximab regimen in skin and tumor biopsies taken before and during treatment. Secondary endpoints were: PK, efficacy, ...

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Abstract

The invention relates to biomarkers based on gene expression products and methods for determining the efficacy of anti-EGFR antibodies in the treatment of EGFR expressing cancer. The invention is further related to the prediction of sensitivity or resistance of a patient suffering from EGFR expressing cancer to the treatment of said patient with a specific anti- EGFR antibody. The invention is preferably related to the identification of respective biomarkers that allow a better prediction of the clinical outcome of the treatment with anti- EGFR antibodies in patients with KRAS wild-type tumors. In this context, the invention especially relates to anti-EFGR antibody c225 / cetuximab (Erbitux TM ) and its use in patients suffering from colorectal Cancer (CRC).

Description

Field of invention: [0001] The present invention relates to gene or gene expression product based biomarkers and methods for determining the efficacy of anti-EGFR antibodies in the treatment of EGFR expressing cancers. The invention further relates to predicting the sensitivity or resistance of patients with EGFR expressing cancers to treatment with specific anti-EGFR antibodies. The present invention preferably relates to the identification of corresponding biomarkers that allow better prediction of the clinical outcome of treatment with anti-EGFR antibodies in patients with KRAS wild-type tumors. In this context, the invention particularly relates to the anti-EGFR antibody c225 / cetuximab and its use in patients with especially colorectal cancer (CRC). Background of the invention [0002] Monoclonal antibodies are widely used in the treatment of cancer. Because antibodies are expensive drugs paid for by national health care agencies and often cause undesired side effect...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68G01N33/574
CPCC12Q1/6886C12Q2600/158C12Q2600/106G01N33/57492G01N2800/52G01N33/57419C12Q2600/156C12N15/11C12Q1/6844C12Q2561/113C12Q2600/136C12Q2600/16G01N2333/4703G01N2333/485G01N2333/495G01N2333/54G01N2333/71G01N2570/00
Inventor C·斯特罗A·范海德布雷克
Owner MERCK PATENT GMBH
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