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Synergistic combined medicine for treating advanced lung cancer by combining anlotinib with immune checkpoint inhibitor

An immune checkpoint and inhibitor technology, applied in the field of medicine, can solve problems such as synergistic drug compositions for advanced lung cancer, and achieve the effects of good safety, good effect and good tolerance

Pending Publication Date: 2022-01-14
SHANGHAI CHEST HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] Previous clinical studies of sintilimab and anlotinib have shown that both single agents have clear pharmacological activity and good tolerability, and have also shown single-agent effectiveness in advanced lung cancer. See related reports on the synergistic pharmaceutical composition composed of sintilimab and anlotinib for the treatment of advanced lung cancer

Method used

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  • Synergistic combined medicine for treating advanced lung cancer by combining anlotinib with immune checkpoint inhibitor
  • Synergistic combined medicine for treating advanced lung cancer by combining anlotinib with immune checkpoint inhibitor
  • Synergistic combined medicine for treating advanced lung cancer by combining anlotinib with immune checkpoint inhibitor

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Example 1 Phase I clinical study of CITIC Dilimab combined with Anlotinib of the present invention

[0033] The clinical research design plan includes:

[0034] The subjects signed the informed consent form before carrying out the research-related procedures; central randomization was adopted, and the stratification factors included: histological type (non-squamous cell carcinoma vs squamous cell carcinoma), smoking history (yes vs no) and PD-L1 expression level (positive vs negative);

[0035] The subject's medical history will be collected by qualified designated personnel. Past medical history includes all previous and currently active diseases. Record autoimmune diseases at any time. Past medical history includes disease diagnosis and treatment. The subject's previous medical history of lung cancer will be recorded in detail separately, including chemotherapy, radiotherapy and surgical treatment, etc., which will not be listed as past medical history; The patient...

Embodiment 2

[0049] Example 2 Phase I clinical study of sintilimab combined with anlotinib

[0050] Based on the theoretical basis of synergy between immune and anti-angiogenic therapy, this example conducted a phase I exploratory study of small-sample combination therapy. From September 2018 to February 2019, 22 patients who had never received systemic anti-tumor therapy were enrolled. For stage IIIB / IV NSCLC with negative driver gene (EGFR / ALK / ROS1), the treatment plan is: sintilimab 200mg, intravenous infusion on the first day of each cycle; combined with anlotinib hydrochloride capsule 12mg once a day Oral, administered on days 1-14 of each cycle; every 3 weeks is a cycle; data as of the first efficacy analysis on April 8, 2019, all patients were under treatment and received at least one efficacy evaluation; 15 cases The patients achieved PR (7 of which were confirmed by secondary imaging evaluation), ORR was 68.2%, 7 patients were SD, and DCR was 100%. Of the 7 SD patients, 5 patients...

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Abstract

The invention belongs to the technical field of medicines, relates to a synergistic medicine of an anti-tumor medicine, and particularly relates to a synergistic combined medicine for treating the advanced lung cancer by combining anlotinib with an immune checkpoint inhibitor, in particular to a synergistic medicine composition for treating the advanced lung cancer, which is composed of the immune checkpoint inhibitor including Czodilithiumab (PD-1 and PD-L1) and the anlotinib. Random contrast research on first-line treatment of the advanced lung cancer shows that the synergistic combined medicine disclosed by the invention has a good effect on treatment of the advanced lung cancer and especially the anti-tumor activity, wherein the objective remission rate (ORR) reaches up to 72, 7%, the disease control rate (DCR) reaches 100%, all biomarker subgroups obtain high remission rates, and the survival-data pre-estimate 6-month progression-free survival (PFS) rate is 93.8%; and the synergistic combined medicine has good treatment tolerance, no unexpected toxicity is observed, no unexpected adverse event is increased, the synergistic combined medicine has good safety, and can be beneficial for being used as a first-line treatment intervention scheme for the advanced or metastatic lung cancer.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to synergistic drugs of anti-tumor drugs, in particular to a synergistic combination drug of anlotinib combined with immune checkpoint inhibitors for the treatment of advanced lung cancer, especially including sintilimab (PD-1 , PD-L1) immune checkpoint inhibitor and anlotinib for the treatment of advanced lung cancer synergistic pharmaceutical composition. Background technique [0002] According to reports, with the prolongation of human life expectancy and the change of life behavior, malignant tumor has become the most threatening disease to human health and life. It is estimated that in 2018, there were 18.1 million new cancer cases worldwide and 9.6 million cancer deaths. Among them, lung cancer is the leading cause of cancer-related deaths in China and around the world. According to estimates from China’s malignant tumor registration data, in 2015, there were about 3.929 mill...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4709A61K45/06A61K39/395A61P35/00A61P35/04
CPCA61K31/4709A61K45/06A61K39/3955A61P35/00A61P35/04A61K2300/00
Inventor 韩宝惠钟华储天晴楼煜清赵怡卓顾爱琴张伟张雪艳王慧敏施春雷熊丽纹
Owner SHANGHAI CHEST HOSPITAL
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