Nova Patents
EP4403228A2

Uses for and article of manufacture including her2 dimerization inhibitor pertuzumab

Abstract

The present application describes uses for and articles of manufacture including 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; combining two HER2 antibodies to treat HER2-positive cancer without increasing cardiac toxicity; treating early-stage HER2-positive breast cancer; treating HER2-positive cancer by co-administering a mixture of Pertuzumab and Trastuzumab from the same intravenous bag; treating HER2-positive metastatic gastric cancer; treating HER2-positive breast cancer with Pertuzumab, Trastuzumab and Vinorelbine; treating HER2-positive breast cancer with Pertuzumab, Trastuzumab and aromatase inhibitor; and treating low HER3 ovarian, primary peritoneal, or fallopian tube cancer. It also describes an article of manufacture comprising a vial with Pertuzumab therein and a package insert providing safety and/or efficacy data thereon; a method of making the article of manufacture; and a method of ensuring safe and effective use of Pertuzumab related thereto. In addition the application describes an intravenous (IV) bag containing a stable mixture of Pertuzumab and Trastuzumab suitable for administration to a cancer patient.

EP4403228A2, drawing sheet 1
Sheet 1 of 36

Term

6 yearsto projected expiry

Projected expiry 11 October 2032, counted from filing; an application has no term until it is granted.

  1. Priority
  2. Filed
  3. Published
  4. Today
  5. Projected expiry

8 claims: 6 independent, 2 dependent

  1. 1
    Pertuzumab for use in combination with trastuzumab and docetaxel in a method for extending progression free survival by 6 months or more and extending overall survival in a HER2-positive breast cancer patient population compared to administration of trastuzumab and docetaxel without pertuzumab, the method comprising administering pertuzumab, trastuzumab and docetaxel to the patients in the population, wherein the HER2-positive breast cancer is metastatic or locally recurrent, unresectable breast cancer, or de novo Stage IV disease.
  2. 4
    Pertuzumab for use according to any one of the preceding claims, wherein the patients in the population have not received prior anti-HER2 therapy or chemotherapy for their metastatic disease.
  3. 5
    Pertuzumab for use according to any one of the preceding claims, wherein the HER2-positive breast cancer is defined as immunohistochemistry (IHC) 3+ and/or fluorescence in situ hybridization (FISH) amplification ratio >2.0.
  4. 6
    Pertuzumab for use according to any one of the preceding claims, wherein the patients in the population have a left ventricular ejection fraction (LVEF) of ≥50% at baseline, wherein the LVEF of ≥ 50% at baseline is determined by echocardiogram or multiple-gated acquisition.
  5. 7
    Pertuzumab for use according to any one of the preceding claims, wherein the patients in the population have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  6. 8
    Pertuzumab for use according to any one of the preceding claims, wherein pertuzumab is for use in combination with trastuzumab and docetaxel in a method for obtaining an objective response rate of 80% or more in the HER2-positive breast cancer patient population.
Independent claims6