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Method for treating EGFR-TKI-resistant non-small cell lung cancer by administration of anti-HER3 antibody-drug conjugate

A technology for non-small cell lung cancer and drug conjugates, which is applied in the field of therapeutic agents for non-small cell lung cancer, and can solve the problems of unrecognized drugs and the like

Active Publication Date: 2019-11-19
DAIICHI SANKYO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, no optimal agent has been recognized for NSCLC resistant to osimertinib
In addition, for non-small cell lung cancer that shows resistance to EGFR-TKI and has been confirmed to be negative for the EGFRT790M mutation, no optimal drug has yet been recognized.

Method used

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  • Method for treating EGFR-TKI-resistant non-small cell lung cancer by administration of anti-HER3 antibody-drug conjugate
  • Method for treating EGFR-TKI-resistant non-small cell lung cancer by administration of anti-HER3 antibody-drug conjugate
  • Method for treating EGFR-TKI-resistant non-small cell lung cancer by administration of anti-HER3 antibody-drug conjugate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0265] Embodiment 1: Preparation of antibody-drug conjugate

[0266] According to the production method described in International Publication No. 2015 / 155998, a heavy chain ( figure 1 ) and a light chain consisting of the amino acid sequence shown in SEQ ID NO: 10 ( figure 2) anti-HER3 antibody (referred to as "anti-HER3 antibody (1)" in the present invention), an anti-HER3 antibody in which a drug linker represented by the following formula is bonded to an anti-HER3 antibody through a thioether bond was produced- Drug Conjugate (referred to as "HER3-ADC(1)" in the present invention). The average number of drugs bound per antibody in HER3-ADC (1) was 7.6.

[0267]

[0268] (In the formula, A represents the binding position with the antibody)

Embodiment 2

[0269] Example 2: Sensitivity test of HER3-ADC (1) for HCC827GR5 cell line

Embodiment 2-1

[0270] Example 2-1: Cell proliferation inhibitory activity against HCC827 cell line and HCC827GR5 cell line

[0271] The HCC827 cell line was cultured in RPMI1640 medium (manufactured by Sigma) containing R10 medium (10% fetal bovine serum and 1% penicillin-streptomycin B (manufactured by Wako Pure Chemical Industries)). The HCC827GR5 cell line was cultured in the above medium containing gefitinib at a final concentration of 1 μM. It should be noted that the HCC827GR5 cell line has been reported to show no strong sensitivity to single-agent treatment with erlotinib and anti-HER3 antibody(1), the antibody portion of HER3-ADC(1) (K Yonesaka et al ., Oncogene (2016) 35, 878-886). After culturing the HCC827 cell line and the HCC827GR5 cell line, they were peeled off by trypsin treatment, the cells were recovered, the number of cells in the cell suspension was measured, suspended in RPMI1640 medium containing 10% fetal bovine serum, and prepared as 100,000 cells / mL concentration....

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Abstract

Provided is a therapeutic agent and a therapeutic method for EGFR-TKI-resistant non-small cell lung cancer. Provided are: a therapeutic agent that contains an anti-HER3 antibody-drug conjugate as an active ingredient; or a therapeutic method characterized by administering an anti-HER3 antibody-drug conjugate.

Description

technical field [0001] The present invention relates to a therapeutic agent and treatment method for EGFR-TKI resistant non-small cell lung cancer, which is characterized in that the anti-HER3 antibody-drug conjugate is administered. Background technique [0002] In the treatment of EGFR tyrosine kinase inhibitor (EGFR-TKI), which is effective for epidermal growth factor receptor (Epidermal Growth Factor Receptor; EGFR) gene mutation-positive non-small cell lung cancer, in most cases, continuous treatment In the course of treatment, the resistance of the target cancer to the inhibitor is enhanced, and the disease is exacerbated as a result. Known: Cancers resistant to Gefitinib and Erlotinib as first-generation EGFR-TKIs, and afatinib as second-generation EGFR-TKIs About half of them have the T790M mutation in the EGFR gene. Osimertinib, which is a third-generation EGFR-TKI, is known as an effective drug against non-small cell lung cancer confirmed to be EGFR T790M mutatio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K31/506A61K31/517A61K31/535A61K45/00A61K47/68A61P11/00A61P35/00
CPCA61K47/6803A61K31/4745A61K31/5377A61K31/506A61K31/517A61P11/00A61P35/00A61K2300/00A61K31/535A61K39/395A61K45/00A61K47/68C07K16/32A61K2039/55A61K2039/86A61K39/39558A61K2039/505C07K2317/73A61K31/444A61K45/06C07K2319/33A61K31/436
Inventor 米阪仁雄中川和彦广谷贤志
Owner DAIICHI SANKYO CO LTD
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