Total and Phosphorylated IL-1 Receptor-Associated Kinase-1 and IL-1 Receptor-Associated Kinase-4 as a Biomarker for Cancer Progression and Chemotherapy Resistance

A pharmaceutical composition comprising therapeutically effective amounts of IRAK-1,-4 inhibitor in a range of from about 1 mg/kg to about 100 mg/kg.

A pharmaceutical composition comprising therapeutically effective amounts of IRAK-1,-4 inhibitor in combination with one or chemotherapeutic drug.

A method for determining if cancer in a subject will be responsive to treatment with a IRAK-1,-4 inhibitor, comprising:

• (a) obtaining a biological sample of cells from the cancer, from the subject;
• (b) assaying the cells in the sample for the presence of an active form of or phosphorylated IRAK-1 or a variant thereof and/or active form of or phosphorylated IRAK-4 or a variant thereof, and;
• (c) if the activated form of or phosphorylated IRAK-1 or variant thereof and/or active form of or phosphorylated IRAK-4 or variant thereof is detected in the cells, then determining that the cancer will respond to treatment with the IRAK-1,-4 inhibitor.

A method comprising identifying a patient having T-ALL and administering a therapeutically effective amount of an IRAK-1,-4 inhibitor to the patient.

A method comprising identifying a patient having melanoma and administering a therapeutically effective amount of an IRAK-1,-4 inhibitor to the patient.

A method comprising

• a) providing a test biological sample from a subject and a control biological sample from a healthy subject,
• b) determining a level of p-IRAK-1 or p-IRAK-4 in the tests and control samples,
• c) and if the expression of p-IRAK-1 or p-IRAK-4 in the test sample is significantly higher than the level of p-IRAKs-1 or p-IRAK-4 expression in the control sample, then determining that the subject is at risk for developing T-ALL.

A method of increasing the efficacy of a chemotherapeutic drug comprising administering an IRAK-1,-4 inhibitor in combination with the chemotherapeutic drug.