Uses for and article of manufacture including her2 dimerization inhibitor pertuzumab

Inactive Publication Date: 2013-04-18
GENENTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes methods for treating breast cancer and stomach cancer using a combination of a drug called Pertuzumab, another drug called Trastuzumab, and chemotherapy. These methods can extend the time it takes for the cancer to come back or spread in patients with HER2-positive breast cancer or stomach cancer that has not received previous treatment. The methods can also improve the effectiveness of treatment and increase the likelihood of a complete response in some patients. Overall, the patent provides new ways to effectively and safely treat cancer with a combination of Pertuzumab, Trastuzumab, and chemotherapy.

Problems solved by technology

Pertuzumab blockade of the formation of HER2-HER 3 heterodimers in tumor cells has been demonstrated to inhibit critical cell signaling, which results in reduced tumor proliferation and survival (Agus et al.

Method used

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  • Uses for and article of manufacture including her2 dimerization inhibitor pertuzumab
  • Uses for and article of manufacture including her2 dimerization inhibitor pertuzumab
  • Uses for and article of manufacture including her2 dimerization inhibitor pertuzumab

Examples

Experimental program
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Effect test

example 1

Phase IIa Study Evaluating Pertuzumab in Combination with Trastuzumab and Chemotherapy in Patients with HER2-Positive Advanced Gastric Cancer

[0254]Despite a sharp worldwide decline in incidence and a reduction in mortality during the second half of the twentieth century, gastric cancer remains the world's second leading cause of cancer mortality, after lung cancer (Parkin, D. Oncogene 23:6329-40 (2004)). The incidence of gastric cancer varies widely according to geographic region (Kelley et al. J Clin Epidemiol 56:1-9 (2003); Plummer et al. Epidemiology of gastric cancer. In: Butlet et al., editors. Mechanisms of carcinogenesis: contribution of molecular epidemiology. Lyon: IARC Scientific Publications No 157, IARC (2004)). In Japan, Korea, China, and certain countries in Central and South America, the incidence is 20 to 95 cases per 100,000 men. In contrast, in the United States, India, and Thailand, the incidence is 4 to 8 cases per 100,000 men. The incidence in Western Europe ran...

example 2

Phase III Study Evaluating Pertuzumab in Combination with Trastuzumab and Chemotherapy in Patients with HER2-Positive Advanced Gastric Cancer

[0366]This is a Phase III, randomized, open-label, multicenter clinical study designed to assess the efficacy of Pertuzumab in combination with Trastuzumab and chemotherapy in patients with HER2-positive locally advanced or metastatic gastric cancer.

[0367]Patients in the treatment arm receive Trastuzumab, cisplatin, and capecitabine and / or 5-fluorouracil. In the other arm, patients are given either placebo or Pertuzumab.

[0368]Treatment Regimens:

[0369]Pertuzumab:

[0370]840 mg dose for cycles 1-6.

[0371]Trastuzumab

[0372]8 mg / kg loading dose followed by 6 mg / kg q3w

[0373]Capecitabine

[0374]1000 mg / m2 bid d1-14 q3w×6

[0375]5-Fluorouracil

[0376]800 mg / m2 / day continuous iv infusion d1-5 q3w×6

[0377]Cisplatin

[0378]800 mg / m2 q3w×6

[0379]Primary End Point:

[0380]Overall survival (OS)

[0381]Secondary End Points:

[0382]Progression-free survival (PFS), time to diseas...

example 3

Results of a Phase III, Randomized, Double-Bind, Placebo-Controlled Registration Trial to Evaluate the Efficacy and Safety of Placebo+Trastuzumab+Docetaxel versus Pertuzumab+Trastuzumab+Docetaxel in Patients with Previously Untreated HER2-Positive Metastatic Breast Cancer (CLEOPATRA)

[0397]A protocol for evaluating Pertuzumab in HER2-positive metastatic breast cancer is found at http: / / clinicaltrials.gov / ct2 / show / NCT00567190 and in US 2009 / 0137387 as well as WO2009 / 154651.

[0398]This example concerns the clinical data obtained in the randomized, double-blind, placebo-controlled Phase III trial in patients with HER2-positive MBC, who had not received chemotherapy or biologic therapy for their metastatic disease. Patients were randomized 1:1 to receive placebo plus Trastuzumab plus Docetaxel or Pertuzumab plus Trastuzumab plus Docetaxel. The primary endpoint was progression-free survival (PFS), based on tumor assessments. PFS was defined as the time from randomization to the first docum...

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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.

Description

[0001]This non-provisional application filed under 37 CFR §1.53(b), claims the benefit under 35 USC §119(e) of U.S. Provisional Application Ser. No. 61 / 547,535, filed on Oct. 14, 2011, U.S. Provisional Application Ser. No. 61 / 567,015, filed on Dec. 5, 2011, U.S. Provisional Application Ser. No. 61 / 657,669, filed on Jun. 8, 2012, U.S. Provisional Application Ser. No. 61 / 682,037, filed on Aug. 10, 2012 and U.S. Provisional Application Ser. No. 61 / 694,584, filed on Aug. 29, 2012, which are incorporated by reference in entirety.FIELD OF THE INVENTION[0002]The present invention concerns uses for and articles of manufacture including Pertuzumab, a first-in-class HER2 dimerization inhibitor.[0003]In particular, the invention concerns 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 c...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61P35/04A61P35/00C07K16/30A61K9/127
CPCA61K45/06C07K16/32A61K2039/507A61K2039/545A61K39/39558C07K2317/24A61K2300/00A61K31/337A61P35/00
Inventor ALAVATTAM, SREEDHARAAMLER, LUKAS C.BENYUNES, MARK C.CLARK, EMMA L.DE TOLEDO PELIZON, CHRISTINA H.KWONG GLOVER, ZEPHANIA W.MITCHELL, LADARATNAYAKE, JAYANTHAROSS, GRAHAM A.WALKER, RU-AMIR
Owner GENENTECH INC
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