Uses for and article of manufacture including her2 dimerization inhibitor pertuzumab

Abstract

The present application describes uses for Pertuzumab, a first-in-class HER2 dimerization inhibitor. In particular, the application describes methods for extending progression free survival in a HER2-positive breast cancer patient population; and combining two HER2 antibodies to treat HER2-positive cancer without increasing cardiac toxicity.

1 .- 42 . (canceled) 
     
     
         43 . A method of combining two HER2 antibodies to treat HER2-positive breast cancer without increasing cardiac toxicity in a HER2-positive breast cancer patient with a left ventricular ejection fraction (LVEF) of ≥50% pre-treatment, comprising administering Pertuzumab, Trastuzumab, and chemotherapy to the patient, and measuring cardiac toxicity in the patient for incidence of symptomatic left ventricular systolic dysfunction (LVSD), congestive heart failure (CHF), or decrease in left ventricular ejection fraction (LVEF), wherein the cardiac toxicity is not increased compared to cardiac toxicity in a patient treated with Trastuzumab and the chemotherapy. 
     
     
         44 . The method of  claim 43 , wherein the breast cancer is metastatic breast cancer. 
     
     
         45 . The method of  claim 43 , wherein the breast cancer is metastatic or locally recurrent, unresectable breast cancer, or de novo Stage IV disease. 
     
     
         46 . The method of  claim 43 , wherein the chemotherapy comprises taxane. 
     
     
         47 . The method of  claim 43 , wherein the taxane is Docetaxel. 
     
     
         48 . The method of  claim 43 , wherein the cardiac toxicity is LVSD. 
     
     
         49 . The method of  claim 43 , wherein the cardiac toxicity is CHF. 
     
     
         50 . The method of  claim 43 , wherein the cardiac toxicity is decrease in LVEF. 
     
     
         51 . The method of  claim 43 , wherein the patient has not received chemotherapy or biologic therapy for their metastatic disease prior to treatment. 
     
     
         52 . A method of treating a patient with HER2-positive breast cancer comprising administering Pertuzumab, Trastuzumab, and chemotherapy to the patient, and measuring left ventricular ejection fraction (LVEF) in the patient and withholding treatment with pertuzumab and trastuzumab for at least 3 weeks if the patient has a drop in LVEF to less than 40%, or a LVEF of 40% to 45% with a 10% or greater absolute decrease below pre-treatment value. 
     
     
         53 . The method of  claim 52 , further comprising resuming treatment with pertuzumab if the LVEF has recovered to greater than 45%, or to 40% to 45% associated with less than a 10% absolute decrease below pretreatment value.