Predicting response to a her inhibitor

Abstract

The present application describes the use of low HER3 as a selection criterion for treating patients with a HER inhibitor, such as pertuzumab. It also describes the use of high HER2:HER3 ratio as a selection criterion for treating cancer patients, such as ovarian cancer patients, with a HER inhibitor, such as pertuzumab. In addition, the application describes the use of high HER3 as a selection criterion for treating cancer patients with a chemotherapeutic agent, for instance gemcitabine.

What is claimed is: 
     
         1 . A method for selecting a therapy for a patient with a type of cancer which is able to respond to a HER dimerization inhibitor comprising determining HER3 expression in a cancer sample from the patient and selecting a HER dimerization inhibitor as the therapy if the cancer sample expresses HER3 at a level less than the median level for HER3 expression in the cancer type. 
     
     
         2 . The method of  claim 1  wherein the patient's cancer expresses HER2:HER3 at a level which is greater than the 25 th  percentile for HER2:HER3 expression in the cancer type. 
     
     
         3 . The method of  claim 2  wherein the patient's cancer expresses HER2:HER3 at a level which is greater than the median level for HER2:HER3 expression in the cancer type. 
     
     
         4 . The method of  claim 3  wherein the patient's cancer expresses HER2:HER3 at a level which is greater than the 75 th  percentile for HER2:HER3 expression in the cancer type. 
     
     
         5 . An article of manufacture comprising, packaged together, a pharmaceutical composition comprising a HER dimerization inhibitor in a pharmaceutically acceptable carrier and a label stating that the inhibitor or pharmaceutical composition is indicated for treating a patient with a type of cancer which is able to respond to a HER dimerization inhibitor, wherein the patient's cancer expresses HER3 at a level less than the median level for HER3 expression in the cancer type. 
     
     
         6 . A method for manufacturing a HER dimerization inhibitor or a pharmaceutical composition thereof comprising combining in a package the inhibitor or pharmaceutical composition and a label stating that the inhibitor or pharmaceutical composition is indicated for treating a patient with a type of cancer which is able to respond to a HER dimerization inhibitor, wherein the patient's cancer expresses HER3 at a level less than the median level for HER3 expression in the cancer type. 
     
     
         7 . A method for advertising a HER dimerization inhibitor or a pharmaceutically acceptable composition thereof comprising promoting, to a target audience, the use of the HER dimerization inhibitor or pharmaceutical composition thereof for treating a patient population with a type of cancer, where the patient's cancer expresses HER3 at a level less than the median level for HER3 expression in the cancer type. 
     
     
         8 . A method for selecting a therapy for a patient with a type of cancer which is able to respond to a chemotherapeutic agent comprising determining HER3 expression in a cancer sample from the patient and selecting a chemotherapeutic agent as the therapy if the cancer sample expresses HER3 at a level greater than the median level for HER3 expression in the cancer type. 
     
     
         9 . The method of  claim 8  wherein the cancer type is ovarian, peritoneal, or fallopian tube cancer. 
     
     
         10 . The method of  claim 9  wherein the cancer type is platinum-resistant ovarian, peritoneal, or fallopian tube cancer. 
     
     
         11 . The method of  claim 9  wherein the cancer type is advanced, refractory, or recurrent ovarian cancer. 
     
     
         12 . The method of  claim 9  wherein the chemotherapeutic agent is an antimetabolite. 
     
     
         13 . The method of  claim 12  wherein the antimetabolite chemotherapeutic agent is gemcitabine.