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Application of pharmaceutical composition containing anti-PD-1 antibody in preparation of drugs for treating advanced non-small cell lung cancer

A non-small cell lung cancer, PD-1 technology, applied in the medical field, can solve the problems of EGFR mutant NSCLC patients not showing survival benefit and high incidence of interstitial pneumonia

Pending Publication Date: 2022-01-07
蒋涛
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, patients with EGFR-mutant NSCLC who received single-agent PD-L1 or PD-1 antibody therapy after failure of EGFR TKIs did not show a substantial survival benefit compared with patients who received standard chemotherapy
In addition, clinical trials of combined use of EGFR TKI and PD-L1 antibodies have led to safety issues such as a high incidence of interstitial pneumonia. For patients, in addition to exploring better treatment strategies, we also need to further look for predictive markers for the efficacy of new treatment strategies, and accurately select EGFR that can benefit from the combination therapy of anti-PD-1 antibodies and cytotoxic anticancer drugs Patients with mutant advanced non-small cell lung cancer, so as to guide the precise and standardized treatment of such patients

Method used

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  • Application of pharmaceutical composition containing anti-PD-1 antibody in preparation of drugs for treating advanced non-small cell lung cancer
  • Application of pharmaceutical composition containing anti-PD-1 antibody in preparation of drugs for treating advanced non-small cell lung cancer
  • Application of pharmaceutical composition containing anti-PD-1 antibody in preparation of drugs for treating advanced non-small cell lung cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] Example 1: Clinical study of anti-PD-1 antibody combined with chemotherapy in the treatment of non-small cell lung cancer

[0109] Inclusion criteria: Eligible subjects must be (1) aged 18-75, (2) suffering from advanced or recurrent non-small cell lung cancer with EGFR sensitive mutations, (3) prior first-line EGFR-TKI treatment Failure, (4) no EGFR T790M mutation, 5) ECOG score 0 or 1, (6) no history of autoimmune disease, (7) no prior anti-PD-1 / or anti-PD-L1 immunity therapy.

[0110] Subjects must have evaluable lesions according to RECIST v1.1 criteria, no combined small cell lung cancer or squamous cell carcinoma, no other mutations that can be used for targeted therapy, no previous systemic chemotherapy, and no acceptance Long-term systemic immunosuppressive therapy.

[0111] From April 2018 to March 2019, 65 patients with EGFR+ NSCLC were screened, and a total of 40 patients were included in this study. The median age of the subjects was 58 years (range: 19 ...

Embodiment 2

[0127] Example 2: Research on the correlation between biomarkers and clinical efficacy

[0128]2.1 WES

[0129] Of the 40 patients enrolled, we performed whole exome sequencing (WES) on tumor biopsies and paired peripheral blood from 34 of the patients. WES identified 7048 gene alterations, including 3505 missense mutations, 84 gene deletions, 123 rearrangements, 119 splice site substitutions, 349 truncations, and 2748 gene amplifications. Noted a significant difference in genetic alterations between partial response (PR) patients and non-PR patients ( Figure 2a ), we reasoned that genetic mutations might be used as predictive markers for this scheme. Genomic predictions of the top 100 most frequently mutated genes in relation to efficacy were performed using Maftools::survGroup (v2.6.05). Considering the small data set, we set a relatively strict criterion (P≤0.01) to screen genes or gene combinations with predictive ability. We found that the predictive model works well...

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Abstract

The invention provides an application of a pharmaceutical composition containing an anti-PD-1 antibody in preparation of drugs for treating advanced non-small cell lung cancer. In addition, the invention also provides a marker, a kit and a method for predicting the therapeutic effect of the pharmaceutical composition. The pharmaceutical composition comprises the anti-PD-1 antibody and a cytotoxic anticancer drug, the drug is used for treating EGFR mutant advanced non-small cell lung cancer patients, and the curative effect of the drug treated by an EGFR small molecule tyrosine kinase inhibitor is failed. The invention provides an effective treatment strategy for a patient who does not have EGFR T790M gene mutation after the EGFR mutant advanced non-small cell lung cancer fails to be treated by an EGFR small molecule tyrosine kinase inhibitor, and genome mutation and expression value efficient treatment are carried out on the patient under the treatment strategy; and the EGFR mutant advanced non-small cell lung cancer patients who can benefit from combined treatment of the anti-PD-1 antibody and the cytotoxic anticancer drugs are accurately selected, and accurate and standardized treatment of the patients is guided.

Description

technical field [0001] The invention relates to the field of medical technology, in particular to the application of a pharmaceutical composition containing an anti-PD-1 antibody in the preparation of a drug for treating advanced non-small cell lung cancer. Background technique [0002] Since 2004, scientists have successively discovered that EGFR gene mutations and their small molecule tyrosine kinase inhibitors (tyrosine kinase inhibitors, TKIs) are effective in the treatment of patients with advanced non-small-cell lung cancer (NSCLC). The important value of EGFR mutation in the treatment of patients with advanced NSCLC has undergone tremendous changes. The median progression-free survival (mPFS) of first-line EGFR TKIs, such as erlotinib, gefitinib, icotinib, afatinib, osimertinib and almonertinib, reaches 10-19 months. However, almost all patients with EGFR-mutant advanced NSCLC are resistant to first-line TKI therapy. After the failure of first-line TKI treatment, th...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K45/06A61P35/00C12Q1/6886
CPCA61K39/3955A61K45/06A61P35/00C07K16/2818C12Q1/6886A61K2039/505C12Q2600/156C12Q2600/158C12Q2600/106
Inventor 蒋涛陈洛南任胜祥周彩存王平洋
Owner 蒋涛
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