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cancer treatment

A tumor-use technology, applied in the fields of oncology, clinical diagnostics, and molecular biology, to solve problems such as roles that are not thoroughly understood

Inactive Publication Date: 2020-01-21
PFIZER INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In particular, the role of tumor-infiltrating lymphocytes in influencing the prognosis of mRCC patients and the sensitivity / resistance to antiangiogenic agents is not thoroughly understood (eg, see Polimeno et al., 2013, BJU Int112:686-696)

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0118] Example 1 - Percentage and Density of CD3 and CD68 Positive Cells in Sections

[0119] This study is a two-arm, randomized, double-blind, multicenter phase 3 study of axitinib versus sorafenib in patients with metastatic renal cell carcinoma (mRCC) in one or more of the following Following failure of prior systemic first-line regimen of agents: sunitinib, bevacizumab + IFNα, temsirolimus, or one or more cytokines. Overall, 723 mRCC patients were randomized and participated in this study, of which 52 axitinib-treated patients were evaluated by immunohistochemical (IHC) analysis; in addition, 33 of the 52 patients had previously treat.

[0120] like figure 1 As shown, the main patients included in the IHC analysis were white (90.4% of patients), male (69.2% of patients) and from North America (57.7% of patients) and Europe (32.7%). The overall mean (standard deviation) age, height and weight were 58.3 (11.0) years, 173.0 (10.0) cm, and 84.6 (19.1) kg, respectively. A...

Embodiment 2

[0124] Example 2 - Higher CD68 expression levels are positively correlated with good ORR and PFS (but not OS)

[0125] For IHC biomarker analysis, a biomarker analysis panel was used that included all patients who received at least one dose of study treatment. The following efficacy endpoints were analyzed: PFS, OS, and objective response rate (ORR). Summary statistics are provided in percent and density of positive cells according to response category (complete response [CR] + partial response [PR] versus steady state disease [SD] + progressive disease [PD] for each marker). Wilcoxon rank sum tests were performed for differences between response categories. Fisher's exact test was used to test the association between the response category and the biomarker stratum using the median value as the cut point. Distributions of OS and PFS were compared between biomarker strata using the Kaplan-Meier method with biomarker median values ​​as cut-off points; p-values ​​are not shown ...

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Abstract

The invention discloses a diagnostic method for predicting whether human tumors are sensitive to axitinib treatment and a method for treating human tumors. These methods are based on measuring the expression level of the CD68 polypeptide in a tumor-derived tissue sample. CD68 expression levels can be measured using immunohistochemistry, wherein the percentage of CD68 positive cells in the tumor and the density of CD68 positive cells can be determined.

Description

technical field [0001] The field of the invention is molecular biology, oncology and clinical diagnostics. Background technique [0002] Most cancer drugs work for some people but not for others. This may be due to genetic variation between tumors and has even been observed between tumors in the same patient. With regard to targeted therapy, individual patient responses are judged specifically. Therefore, without appropriate tests to determine which patients will benefit from which drug, the full potential of targeted therapy cannot be understood. According to the National Institutes of Health (NIH), the term "biomarker" is defined as "a characteristic that is objectively measured and evaluated as an indicator of a normal biological process or a pathogenic process or a pharmacological response to a therapeutic intervention". [0003] The development of improved diagnostics based on biomarker discovery has the potential to accelerate the development of new drugs by pre-ide...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/574A61K31/4439A61P35/00
CPCA61K31/4439C07K16/2896G01N33/57484G01N33/57492G01N2333/70596G01N2800/52A61P1/04A61P1/18A61P11/00A61P13/12A61P15/00A61P35/00A61K39/395G01N33/574
Inventor J-F·A·马丁尼J·C·塔拉齐J·A·威廉斯
Owner PFIZER INC
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