Claims
- 1. A method for predicting a response to an epidermal growth factor receptor-directed therapy in a human subject, the method comprising the step of assaying a tumor sample from the human subject before therapy with one or a plurality of reagents that detect expression and/or activation of predictive biomarkers for cancer; and determining a pattern of expression and/or activation of at least two of said predictive biomarkers, wherein the pattern predicts the human subject's response to the epidermal growth factor receptor-directed therapy.
- 2. The method of claim 1, wherein the predictive biomarker is a growth factor receptor, or a growth factor receptor-related downstream signaling molecule.
- 3. The method of claim 2, wherein the growth factor receptor is HER1 (EGFR), pHER1, HER2/neu, HER3, or any combination thereof.
- 4. The method of claim 2, wherein the growth factor receptor-related downstream signaling molecules is pERK.
- 5. The method of claim 2, wherein the growth factor receptor is HER1 (EGFR), pHER1, HER2/neu, HER3, or any combination thereof, and the growth factor receptor-related downstream signaling molecules is pERK.
- 6. The method of claim 1, where in the predictive biomarkers are HER1 (EGFR) and HER3.
- 7. The method of claim 6, wherein when HER1 (EGFR) is undetectable is predictive of the human subject not responding to the epidermal growth factor receptor-directed therapy.
- 8. The method of claim 6, wherein when HER3 is undetectable is predictive of the human subject responding to the epidermal growth factor receptor-directed therapy.
- 9. The method of claim 1, where in the predictive biomarkers are HER1 (EGFR) and pERK.
- 10. The method of claim 1, where in the predictive biomarkers are pERK and HER3.
- 11. The method of claim 1, where in the predictive biomarkers are HER1 (EGFR), HER3, and pERK.
- 12. A kit for determining a response to an epidermal growth factor receptor-directed therapy in a subject comprising at least two reagents that detect expression and/or activation of predictive biomarkers for cancer.
- 13. The kit of claim 12, wherein said kit comprises at least three reagents that detect expression and/or activation of predictive biomarkers for cancer.
- 14. The kit of claim 12, where the predictive biomarkers are HER1, HER3, pERK or any combination thereof.
- 15. The kit of claim 13, where the predictive biomarkers are HER1, HER3, pERK or any combination thereof.
- 16. A method for predicting a response to a cancer therapy in a human subject, the method comprising the step of assaying a cell or tissue sample from the human subject before therapy with one or a plurality of reagents that detect expression and/or activation of predictive biomarkers for cancer, wherein said predicative biomarkers consist of growth factor receptor ligands; and determining a pattern of expression and/or activation of at least two of said predictive biomarkers, wherein the pattern predicts the human subject's response to the cancer therapy.
- 17. The method of claim 16, wherein the growth factor receptors are HER1 (EGFR), pHER1, HER2/neu, HER3 or any combination thereof.
- 18. The method of claim 17, wherein the cancer therapy is an epidermal growth factor receptor-directed therapy.
- 19. The method of claim 18, wherein the cancer therapy is an anti-EGFR antibody.
- 20. The method of claim 19, wherein the antibody is ABX-0303.
- 21. A method of selecting a subject with cancer for treatment with a molecule targeting epidermal growth factor receptor (EGFR), comprising determining the level of expression of HER3 in a cell or tissue sample from the subject, wherein if the level of HER3 expression is low in the cells, the subject is selected.
- 22. The method of claim 21, wherein the molecule is an anti-EGFR antibody.
- 23. The method of claim 22, wherein the antibody is ABX-0303.
- 24. The method of claim 21, wherein the determining step further comprises determining expression of one or more of HER1 (EGFR), pHER1, HER2/neu, and pERK.
- 25. A method of predicting the likely response rate to a molecule targeting epidermal growth factor receptor (EGFR) of a subject having a cancer that overexpresses EGFR, comprising the step of determining the level of expression of HER3 in a cell or tissue sample from the subject, wherein if the level of HER3 expression is low in the cells, the subject is likely to respond to the molecule targeting EGFR.
- 26. The method of claim 25, wherein the molecule is an anti-EGFR antibody.
- 27. The method of claim 26, wherein the antibody is ABX-0303.
- 28. The method of claim 25, wherein the determining step further comprises determining expression of one or more of HER1 (EGFR), pHER1, HER2/neu, and pERK.
- 29. A method of treating a subject with cancer, comprising determining the level of expression of HER3 in the cells from the subject, and treating the subject with an anti-EGFR antibody when HER3 expression levels in the cell are low.
- 30. The method of claim 29, wherein the antibody is ABX-0303.
- 31. The method of claim 29 wherein the determining step further comprises determining expression of one or more of HER1 (EGFR), pHER1, HER2/neu, and pERK.
- 32. The method of claim 31, wherein the antibody is ABX-0303.
- 33. The method of claim 29, wherein the level of expression of HER3 is undetectable.
- 34. The method of claim 33, wherein the antibody is ABX-0303.
- 35. A method of selecting a subject with cancer for treatment with a molecule targeting epidermal growth factor receptor (EGFR), the method comprising:
a) determining an expression and/or activation profile of two or more growth factor receptors in cells and/or tissues of the subject; and b) selecting the subject based on the expression and/or activation profile, wherein the subject is selected when the level of expression of HER3 is low, the level of expression of the HER1 is high, and/or the level of the pERK index is high.
- 36. The method of claim 35, wherein the molecule is an anti-EGFR antibody.
- 37. The method of claim 36, wherein the antibody is ABX-0303.
- 38. The method of claim 37, wherein the growth factor receptors comprise one or more of HER1 (EGFR), pHER1, HER2/neu, and HER3.
Parent Case Info
[0001] This application claims the benefit of priority to U.S. Provisional Application Serial No. 60/389,796, filed Jun. 19, 2002.
Provisional Applications (1)
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Number |
Date |
Country |
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60389796 |
Jun 2002 |
US |