Extending survival of cancer patients with elevated levels of egf or tgf-alpha

A TGF-, patient-based technology, applied in the field of EGF or TGF-α, to address issues such as tumor expansion and reduced survival

Inactive Publication Date: 2009-07-29
GENENTECH INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0021] Blockade of HER2-HER3 heterodimer formation in tumor cells by Pertuzumab has been shown to inhibit critical cell signaling, resulting in reduced tumor expansion and survival (Agus et al., Cancer Cell 2: 127-37 (2002))

Method used

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  • Extending survival of cancer patients with elevated levels of egf or tgf-alpha
  • Extending survival of cancer patients with elevated levels of egf or tgf-alpha
  • Extending survival of cancer patients with elevated levels of egf or tgf-alpha

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0301] Example 1 provides a specific serum ELISA bioassay protocol.

[0302] EGF and / or TGF-alpha can also be assessed using in vivo diagnostic assays, for example, by administering a molecule (such as an antibody) that binds to the molecule to be detected and labeled with a detectable marker (e.g., a radioactive isotope), followed by external scanning of the patient for Locate the marker.

[0303] In addition to assessing EGF and / or TGF-α, HER expression or amplification in cancer can be determined. A variety of diagnostic / prognostic assays are available for this purpose. In one embodiment, HER overexpression can be analyzed by IHC, for example using (Dako). Paraffin-embedded tissue sections from tumor biopsies can be subjected to IHC assays against the following criteria for HER2 protein staining intensity:

[0304] Score 0: No staining was observed or membrane staining was observed in less than 10% of tumor cells.

[0305] Score 1+: faint / just perceptible membrane sta...

Embodiment

[0358] Example 1: Clinical Serum Biomarker Analysis in Ovarian Cancer Patients Treated with Pertuzumab

[0359] Research design

[0360] An open-label, single-arm, multicenter phase II study was conducted to evaluate the effect of tumor-based HER2 activation on rhuMAb 2C4 (Pertuzumab) in patients with advanced, refractory or Effects on Efficacy in Subjects with Recurrent Ovarian Cancer.

[0361] In trial cohort 1, 65 subjects with advanced ovarian cancer refractory to or relapsed after prior chemotherapy were enrolled and received 420 mgrhuMAb (Pertuzumab) per cycle. Of these, 61 subjects received treatment, and 4 subjects withdrew from the study without receiving any pertuzumab treatment.

[0362] Subjects enrolled in Arm 1 who met the inclusion criteria underwent biopsy of tumor tissue or aspiration of tumor cells from ascites. The tissue was analyzed for HER2 phosphorylation by ELISA, ie quantitative measurement of phosphorylated HER2 and total HER2 in the samples.

...

Embodiment 2

[0435] Example 2: Serum Biomarker Analysis in Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Patients Treated with Pertuzumab and Chemotherapy

[0436] Research design

[0437] A randomized, placebo-controlled, double-blind, multicenter phase II clinical trial was conducted in subjects with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer A preliminary assessment of the efficacy of Pertuzumab (rhuMAb 2C4) in combination with the chemotherapeutic agent gemcitabine versus gemcitabine in combination with placebo, as measured by progression-free survival (PFS) for all subjects, was performed in . Another trial objective was to assess the safety and tolerability of pertuzumab plus gemcitabine versus gemcitabine plus placebo in subjects with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer.

[0438] Subjects who experienced disease progression at or within 6 months of receiving a platinum-based chemotherapy regimen administer...

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Abstract

The present application describes extending survival in a cancer patient, where the patient is producing an elevated level of EGF or TGF-alpha, by treating the patient with a HER dimerization inhibitor, such as pertuzumab.

Description

field of invention [0001] The present invention relates to prolonging the survival of cancer patients who produce elevated levels of EGF or TGF-α by treating the patient with an inhibitor of HER dimerization, such as Pertuzumab. Background of the invention [0002] HER receptor and antibodies against it [0003] The HER receptor tyrosine kinase family is an important mediator of cell growth, differentiation or survival. This family of receptors includes four distinct members, including epidermal growth factor receptor (EGFR, ErbB1 or HER1), HER2 (ErbB2 or p185 neu ), HER3 (ErbB3) and HER4 (ErbB4 or tyro2). [0004] EGFR, encoded by the erbB1 gene, is thought to have a causal relationship with human malignancies. Specifically, elevated EGFR expression was observed in breast, bladder, lung, head, neck, and gastric cancers, as well as glioblastoma. Elevated expression of the EGFR receptor is often associated with increased production of the EGFR ligand, transforming growth ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395C07K16/32
CPCA61K39/39558C07K16/3069Y02E50/16A61K45/06A61K2039/505C07K16/3046C07K16/32A61P1/00A61P15/00A61P35/00A61P43/00A61K2300/00A61K39/395
Inventor 卢卡斯·C·阿姆勒乔基姆·莫克斯努斯拉特·拉贝安德烈亚斯·斯特劳斯
Owner GENENTECH INC
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