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Biomarkers for combination therapy comprising lenvatinib and everolimus

A technology of lenvatinib and combination therapy, applied in biological testing, biomaterial analysis, active ingredients of heterocyclic compounds, etc., can solve problems that have not been disclosed or indicated, and cannot predict the responsiveness of angiogenesis inhibitors

Inactive Publication Date: 2018-01-19
EISIA R&D MANAGEMENT CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, US 2012 / 0077837 does not disclose or suggest that Ang2 can be used as a predictor of the responsiveness of patients with renal cell carcinoma to a combination therapy comprising a lenvatinib compound (eg lenvatinib mesylate) and everolimus, Not to mention the preference for this combination over monotherapy with everolimus
[0008] Literature (Llovet et al., Clin. Cancer Res. [Clinical Cancer Research], 18(8):2290-2300 (2012)) reported that in patients with advanced hepatocellular carcinoma, although the angiogenic biomarkers Ang2 and VEGF are predictors of survival, but these biomarkers do not predict responsiveness to the angiogenesis inhibitor-sorafenib

Method used

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  • Biomarkers for combination therapy comprising lenvatinib and everolimus
  • Biomarkers for combination therapy comprising lenvatinib and everolimus

Examples

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example 1

[0104] Example 1: Biomarkers for identifying a subgroup of renal cell carcinoma patients requiring combination therapy comprising lenvatinib and everolimus

[0105] Objective: A phase 2 study of lenvatinib was conducted in patients with metastatic renal cell carcinoma (RCC) following VEGF-targeted therapy. The importance of angiogenesis in RCC underscores the need to understand the clinical mechanisms behind anti-angiogenic therapies such as everolimus. A clinical biomarker analysis was performed to identify predictive markers of clinical benefit in RCC patients on combination therapy comprising lenvatinib and everolimus compared with everolimus monotherapy.

[0106] The purpose of the assay is to measure Ang2 levels in blood samples (e.g., serum) obtained from patients before and after treatment with lenvatinib, everolimus, or a combination thereof in a clinical trial, and To identify blood biomarkers that can be used to predict whether a patient will need the combination th...

specific Embodiment

[0110] Specific embodiments of the present invention are as follows:

[0111] (1) A method for identifying a human subject suffering from, suspected of suffering from, or at risk of developing renal cell carcinoma in need of a combination therapy comprising lenvatinib or a pharmaceutically acceptable salt thereof and everolimus , the method includes:

[0112] Before administering a combination therapy comprising lenvatinib or a pharmaceutically acceptable salt thereof and everolimus, assaying a biological sample obtained from the human subject and determining angiopoietin-2 in the biological sample (Ang2) protein concentration is high compared to the control; and

[0113] A human subject having a high concentration of Ang2 protein in the biological sample is identified as being in need of a combination therapy comprising lenvatinib or a pharmaceutically acceptable salt thereof and everolimus.

[0114] (2) The method as described in (1), wherein the biological sample is selec...

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Abstract

Biomarkers are provided that predict whether a human subject having a renal cell carcinoma is in need of a combination therapy comprising lenvatinib or a pharmaceutically acceptable salt thereof (e.g., lenvatinib mesylate) and everolimus. The biomarkers, compositions, and methods described herein are useful in selecting appropriate treatment modalities for and treating a subject having, suspectedof having, or at risk of developing a renal cell carcinoma.

Description

technical field [0001] The present invention relates generally to biomarkers and renal cell carcinoma. Background technique [0002] Many kinase inhibitors have been developed as antineoplastic agents. For example, a group of compounds with inhibitory activity against receptor tyrosine kinases (eg, vascular endothelial growth factor receptor (VEGFR)) are known to inhibit angiogenesis and are considered a new class of antineoplastic agents. Lenvatinib mesylate (also known as E7080) is an oral tyrosine kinase inhibitor that targets VEGFR1-3, fibroblast growth factor receptor (FGFR)1-4, transgenic Rearranged during transfection receptor (RET), KIT, and platelet-derived growth factor receptor (PDGFR). The U.S. Food and Drug Administration has approved lenvatinib mesylate as LENVIMA TM , for the treatment of patients with locally recurrent or metastatic, progressive, radioactive, iodine-refractory differentiated thyroid cancer. Phase 2 and 3 studies are ongoing in other tumor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/574
CPCG01N33/57438A61P13/12A61P35/00G01N2333/71G01N33/57484A61K31/436A61K31/47A61K2300/00G01N33/574G01N33/6872G01N2800/52G01N33/68
Inventor 船桥泰博门胁正史
Owner EISIA R&D MANAGEMENT CO LTD
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