Method for treating squamous non-small cell lung cancer by anti-PD-1 antibody or antigen-binding fragment thereof

A non-small cell lung cancer, PD-1 technology, applied in the direction of anti-receptor/cell surface antigen/cell surface determinant immunoglobulin, antibody medical components, antibodies, etc.

Pending Publication Date: 2022-06-10
INNOVENT BIOLOGICS (SUZHOU) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The effect of second-line therapy is limited, and the median survival time is about 6 months [Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med 2015,373:123-135], there is a great unmet medical need
[0005] In view of the limited effect of docetaxel in the treatment of second-line squamous non-small cell lung cancer, such as the short median overall survival time, it is urgent to explore immune checkpoint inhibition Agents in second-line squamous non-small cell lung cancer treatment strategy

Method used

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  • Method for treating squamous non-small cell lung cancer by anti-PD-1 antibody or antigen-binding fragment thereof
  • Method for treating squamous non-small cell lung cancer by anti-PD-1 antibody or antigen-binding fragment thereof
  • Method for treating squamous non-small cell lung cancer by anti-PD-1 antibody or antigen-binding fragment thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Antibodies and other drugs tested

[0060] The anti-PD-1 antibody used in the present invention is sintilimab (10 mL: 100 mg) produced by Innovent Biopharma (Suzhou) Co., Ltd.

[0061] Docetaxel: Specification: 20mg / 0.5mL, 40mg / 1mL or 80mg / 2mL

[0062] Main inclusion criteria

[0063] 1. Cytological or histological diagnosis of squamous non-small cell lung cancer;

[0064] 2. Locally advanced, metastatic or recurrent (that is, stage IIIB, IIIC or IV that does not meet the criteria for radical radiotherapy and chemotherapy) NSCLC (according to the 8th edition of the UICC / AJCC staging system), the following four situations are acceptable:

[0065] 1) Disease progression (RECISTv1.1) occurs during or after first-line platinum-containing chemotherapy (including during maintenance chemotherapy), and one of the drugs is allowed to be discontinued, reduced or replaced with similar drugs in the first-line treatment;

[0066] 2) Cannot tolerate the toxicity of first-line plat...

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Abstract

The invention relates to application of an anti-PD-1 antibody or an antigen binding fragment thereof in a medicine for treating squamous non-small cell lung cancer. The invention also provides a single drug dosage unit and a kit comprising an effective amount of an anti-PD-1 antibody or antigen-binding fragment thereof. The invention further provides application of the single drug dosage unit or the kit in preparation of drugs for treating squamous non-small cell lung cancer, and preferably, the squamous non-small cell lung cancer is advanced or metastatic squamous non-small cell lung cancer caused by failure of first-line platinum-containing chemotherapy.

Description

technical field [0001] The present invention relates to a method for treating squamous non-small cell lung cancer with an anti-PD-1 antibody or an antigen-binding fragment thereof, and to a use of the anti-PD-1 antibody or an antigen-binding fragment thereof in preparing a medicine for treating squamous non-small cell lung cancer. Background technique [0002] With the prolongation of human life expectancy and the change of life style, malignant tumor has become a serious threat to the health of Chinese people and constitutes a major disease that threatens life. Lung cancer, in particular, ranks first among malignant tumors in its morbidity and mortality due to the huge smoking population. According to statistics in 2015, the incidence and death rate of lung cancer in China were 733,000 and 600,000, respectively, the highest in the world [http: / / globocan.iarc.fr / Default.aspx]. There are few effective treatments for advanced squamous cell carcinoma of the lung. The first-lin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395C07K16/28A61P35/00A61P35/04
CPCC07K16/2818A61K39/3955A61P35/00A61P35/04C07K2317/565C07K2317/56C07K2317/76A61K2039/86A61K2039/505
Inventor 周辉王树彦孙路尧
Owner INNOVENT BIOLOGICS (SUZHOU) CO LTD
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