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Extending time to disease progression or survival in cancer patients

a cancer patient and disease technology, applied in the field of extending time to disease progression or survival in a cancer patient, can solve the problems of reducing tumor proliferation and survival

Inactive Publication Date: 2009-06-18
GENENTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides clinical data from patients treated with a drug called pertuzumab, which inhibits the growth of cancer cells by blocking a protein called HER2. The data shows that patients who have cancer that is activated by HER2 experienced a benefit from treatment with pertuzumab, with some patients showing a delay in the time it takes for their cancer to come back or die. The invention also covers a method for treating patients with ovarian, peritoneal, or fallopian tube cancer by giving them pertuzumab to extend the time it takes for their cancer to come back or die, if it is activated by HER2.

Problems solved by technology

Pertuzumab blockade of the formation of HER2-HER3 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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  • Extending time to disease progression or survival in cancer patients
  • Extending time to disease progression or survival in cancer patients
  • Extending time to disease progression or survival in cancer patients

Examples

Experimental program
Comparison scheme
Effect test

example 1

Clinical Activity of Pertuzumab in Advanced, Refractory or Recurrent Ovarian Cancer and the Role of HER2 Activation Status

[0351]This example concerns a single arm, open label, multicenter phase II clinical trial of ovarian cancer patients. Patients with advanced, refractory or recurrent ovarian cancer were treated with pertuzumab, a humanized HER2 antibody. Pertuzumab represents a new class of targeted agents called HER dimerization inhibitors (HDIs) that inhibit dimerization of HER2 with EGFR, HER3 and HER4, and inhibit signaling through MAP and P13 kinase.

[0352]65 patients with relapsed ovarian cancer were enrolled with 61 receiving therapy with “low dose” single agent pertuzumab; pertuzumab was administered intravenously (IV) with a loading of 840 mg followed by 420 mg every 3 weeks.

[0353]A second cohort of patients was treated with “high dose” pertuzumab; 1050 mg every 3 weeks, administered as a single agent. In this cohort, 64 subjects were enrolled, with 62 subjects being trea...

example 2

Phospho-HER2 ELISA for Determining HER2 Activation

[0365]Example 1 above describes the clinical trial which evaluated the efficacy of pertuzumab in subjects with advanced, refractory or recurrent ovarian cancer. This example describes development of the assay used to determine HER2 activation in the patients treated in Example 1.

[0366]The phospho-HER2 ELISA was developed to measure the concentration of HER2-associated tyrosine phosphorylation (HER2 / pTyr) in human ovarian tumor tissue lysates. The assay utilizes COSTAR™ 96-well, half-area, microtiter plates because of limited sample volume. The coat antibody is an affinity purified goat anti-HER2 ECD and the secondary antibody is a biotinylated murine monoclonal (clone 4G10) specific for phosphotyrosine. The reference standard is a SK-BR-3 cell lysate with an assay range of 132 U / mL. One unit equals the amount of phosphorylated tyrosine measured in a SK-BR-3 cell lysate containing 277 pg total HER2 as determined by the Total HER2 ELIS...

example 3

Gene Expression Profiling for Determining HER2 Activation

[0414]This example shows how HER2 activation can be evaluated by determining gene expression profiles as an alternative to determining HER2 phosphorylation directly. This profiling may be done on fresh, frozen, or formalin-fixed, paraffin-embedded ovarian tumor specimens, but preferably the latter.

[0415]Ovarian cancer specimens treated with pertuzumab were profiled for gene expression using AFFYMETRIX® microarray analysis performed according to the manufacturer's instructions. The microarray expression data was analyzed to identify gene patterns which would be associated with HER2 phosphorylation status. Remarkably, a pattern emerged where tumors with relatively high levels of expression of EGFR, HER2, HER3, and the HER ligand betacelullin were also positive for HER2 phosphorylation. The correlation was positive in six of the six HER2 phosphorylation positive cases, and none of the HER2 phosphorylation negative cases were pred...

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Abstract

The present application describes extending time to disease progression or survival in a cancer patient, where the patient's cancer displays HER activation, by treating the patient with a HER dimerization inhibitor, such as pertuzumab.

Description

[0001]This is a continuation application which claims priority under 35 USC § 120 to non-provisional application Ser. No. 11 / 359,185, filed Feb. 21, 2006, which claims priority under 35 USC §119 to provisional application No. 60 / 655,277, filed 23 Feb. 2005, the entire disclosures of which are incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention concerns extending time to disease progression or survival in a cancer patient, where the patient's cancer displays HER activation, by treating the patient with a HER dimerization inhibitor, such as pertuzumab.BACKGROUND OF THE INVENTIONHER Receptors and Antibodies Thereagainst[0003]The HER family of receptor tyrosine kinases are important mediators of cell growth, differentiation and survival. The receptor family includes four distinct members including epidermal growth factor receptor (EGFR, ErbB1, or HER1), HER2 (ErbB2 or p185neu), HER3 (ErbB3) and HER4 (ErbB4 or tyro2).[0004]EGFR, encoded by the erbB1 gene, h...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/395A61P35/00
CPCA61K39/395A61K2039/505C07K16/32C07K16/3069A61K31/7068A61K39/39558A61K45/06C07K2317/21A61P1/04A61P11/00A61P13/08A61P15/00A61P35/00A61P35/04A61P43/00C07K2317/24C07K2317/56
Inventor DERYNCK, MIKA K.KELSEY, STEPHEN M.
Owner GENENTECH INC
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