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Biomarkers for prediction of response to anti-EGFR therapy in cancer

Value Proposition

Colorectal cancer affects over 1.2 million people in the US alone, at a rate of 134,000 new cases each year, with the majority of cases classified as metastatic colorectal cancer (mCRC). One of the molecular pathways thought to mediate progression of mCRC is the epidermal growth factor receptor (EGFR) signaling pathway, which can be targeted therapeutically by inhibiting EGFR signaling. Of the EGFR-targeted therapies, one of the most promising is cetuximab (Erbitux), an anti-EGFR monoclonal antibody. Despite promising results in some patients, only 10-40% of mCRC patients demonstrate a clinical response to the drug. Given the high cost of cetuximab treatment and potential for adverse effects, the ability to discriminate which patients are likely to respond to cetuximab treatment could be of great value to both patients and physicians. This technology provides an assay for the prediction of cetuximab response in mCRC patients by quantifying biomarker expression in tumor biopsies, enabling a personalized medicine approach to the use of cetuximab therapy in mCRC.


This technology provides a means for predicting response to cetuximab therapy in patients with KRAS-wild-type mCRC by measuring the expression the novel biomarkers CD73, HER3, EGF, EGFR, HB-EGF, BTC, HER2, HER4, and/or DUSP4 in tumor biopsies and/or blood samples. Using protein- or mRNA-based measurement methods, levels of these markers in patient samples can be compared to reference levels to determine whether a patient is likely or unlikely to respond to cetuximab therapy.

Other applications

These biomarkers have also demonstrated utility as prognostic indicators of overall survival in mCRC, and may therefore be useful irrespective of cetuximab treatment to generate informed clinical decisions. Importantly, the prognostic utility of these markers extends to both KRAS-wild-type and KRAS-mutant tumors, broadening the potential market of this assay.


  • Although studies indicate only 10-40% of mCRC patients are responsive to cetuximab therapy, current methods cannot predict which patients are likely or unlikely to respond.
  • This technology provides a biomarker-based method to predict cetuximab responsiveness in mCRC patients, allowing more informed treatment decisions that may improve patient outcomes
  • Biomarkers used in this technology are also useful in determining patient prognosis in terms of surival

Duke File (IDF) Number



  • Nixon, Andrew
  • Cushman, Stephanie
  • Hatch, Ace
  • Hurwitz, Herbert
  • Jiang, Chen
  • Owzar, Kouros
  • Shterev, Ivo
  • Sibley, Alex

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School of Medicine (SOM)