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Pharmaceutical composition for treating advanced breast cancer

A technology for advanced breast cancer and its composition, which is applied in drug combinations, antineoplastic drugs, pharmaceutical formulations, etc., can solve the problems of single target and inapplicability, and achieve the effect of significant survival benefit and safe and controllable treatment plan

Active Publication Date: 2022-05-27
SUN YAT SEN MEMORIAL HOSPITAL SUN YAT SEN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The patent document "Peptidomimetic Macrocyclic Compounds and Their Uses" (Application No. 201680064031.0, Publication No. CN108348571A) discloses the treatment of breast cancer, and also discloses microtubule inhibitors, Bruton's tyrosine kinase inhibitors (or protein kinase Inhibitor) and the use of anti-PD-1 monoclonal antibody, but its main technical scheme is to use P53 targeting drug for the treatment of cancer, the disclosed microtubule inhibitor, Bruton's tyrosine kinase inhibitor ( or protein kinase inhibitors) and anti-PD-1 monoclonal antibodies are also used in combination with P53-targeted drugs to achieve the purpose of tumor treatment, that is to say, the core technology of this patent document lies in the use of P53-targeted drugs, Its defect is that it has a single target and is a broad-spectrum cancer treatment drug, but it is not suitable for the back-line treatment of the failure of the front-line treatment

Method used

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  • Pharmaceutical composition for treating advanced breast cancer
  • Pharmaceutical composition for treating advanced breast cancer
  • Pharmaceutical composition for treating advanced breast cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] A pharmaceutical composition for the treatment of advanced breast cancer, the synergistic active ingredients include a therapeutically effective amount of a PD-1 / PD-L1 inhibitor, a therapeutically effective amount of an angiogenesis inhibitor and a therapeutically effective amount of a microtubule inhibitor .

[0109] In the pharmaceutical composition, the synergistic active ingredients are combined in any one of the following ways:

[0110] A therapeutically effective amount (PD-1 / PD-L1 inhibitor + angiogenesis inhibitor + microtubule inhibitor);

[0111] A therapeutically effective amount (PD-1 / PD-L1+ angiogenesis) dual anti-inhibitor and a therapeutically effective amount of a microtubule inhibitor.

[0112] The PD-1 inhibitor is an anti-PD-1 antibody or an antigen-binding portion thereof, preferably an anti-PD-1 monoclonal antibody, more preferably a recombinant humanized anti-PD-1 monoclonal antibody.

[0113] The recombinant humanized anti-PD-1 monoclonal antibo...

Embodiment 2

[0125] Use of PD-1 / PD-L1 inhibitors, angiogenesis inhibitors and microtubule inhibitors in the preparation of pharmaceutical compositions for the treatment of advanced breast cancer.

[0126] PD-1 / PD-L1 inhibitors are anti-PD-1 / PD-L1 antibodies or antigen-binding portions thereof; angiogenesis inhibitors are small molecule kinase inhibitors; microtubule inhibitors are microtubule dynamics inhibitors.

[0127] PD-1 / PD-L1 inhibitor is anti-PD-1 / PD-L1 monoclonal antibody; angiogenesis inhibitor is small molecule tyrosine kinase inhibitor; microtubule inhibitor is halichondrin-type microtubule kinetics inhibitor agent.

[0128] The PD-1 / PD-L1 inhibitor is a recombinant humanized anti-PD-1 / PD-L1 monoclonal antibody; the angiogenesis inhibitor is apatinib or a pharmaceutically acceptable salt thereof; the microtubule inhibitor is Apatinib Ribulin, its pharmaceutically acceptable salts.

[0129] The advanced cancer is advanced melanoma, non-small cell carcinoma, renal cell carcinom...

Embodiment 3

[0131] The pharmaceutical composition for the treatment of advanced breast cancer provided by embodiment 1 or embodiment 2 is the following three kinds:

[0132] Recombinant humanized anti-PD-1 monoclonal antibody, commonly known as camrelizumab for injection (trade name ), which was approved for marketing in China in May 2019. Previous research data shows that the recombinant humanized anti-PD-1 monoclonal antibody injection developed by Hengrui Medicine has comparable in vivo efficacy and safety and may have better anti-tumor clinical application potential.

[0133] Tyrosine kinase inhibitor, commonly known as apatinib mesylate tablets (commodity ), the China Food and Drug Administration approved apatinib for marketing on November 17, 2014. Apatinib has shown corresponding efficacy in the treatment of advanced TNBC phase II clinical trials, which can significantly prolong the progression-free survival (PFS) of patients.

[0134] Microtubule inhibitor, commonly known as ...

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Abstract

The invention provides a pharmaceutical composition for treating advanced breast cancer, which has synergistic active ingredients including a therapeutically effective amount of PD-1 / PD-L1 inhibitor, an angiogenesis inhibitor and a microtubule inhibitor, and provides application of the pharmaceutical composition. Compared with the prior art, the invention has the following advantages: the treatment scheme of the triple medicinal composition has a good curative effect on a patient, the PFS of the patient reaches 8.1 months, and the survival benefit of the patient is obvious; the traditional Chinese medicine composition is wide in audiences and suitable for PD-L1 negative patients, analysis shows that the treatment effect of the scheme is not affected by previous immunotherapy, the treatment effect is irrelevant to immune typing, and the patient audiences are expanded; the traditional Chinese medicine composition is safe and controllable, patients receiving the treatment scheme are free of death caused by treatment side effects, serious side effects comprise neutropenia, thrombocytopenia, transaminase increase, neutropenia and the like, and the side effects are clinically accepted to be safe and controllable.

Description

technical field [0001] The invention relates to the technical field of cancer therapeutic drugs, in particular to a pharmaceutical composition for the treatment of advanced breast cancer. [0002] technical background [0003] Breast cancer ranks first among female cancers in China and is on the rise. It is a common malignant tumor that endangers women's health. Breast cancer is the sum of a class of diseases, at least divided into four molecular subtypes: luminal A, luminal B, HER2 overexpression and triple negative. Among them, triple-negative breast cancer (TNBC) accounts for ~15% of the total breast cancer cases, and has the characteristics of high early recurrence rate, high distant metastasis rate, poor prognosis, and low survival rate. Due to the lack of effective targeted therapy drugs for advanced metastatic TNBC, the current international consensus on treatment recommends chemotherapy, that is, the first-line treatment of patients with positive PD-L1 expression rec...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61K39/395A61P35/00A61K31/444A61K31/357
CPCA61K45/06A61K39/3955A61P35/00A61K2039/505A61K31/444A61K31/357A61K2300/00
Inventor 刘洁琼田圳銮汪颖林颖
Owner SUN YAT SEN MEMORIAL HOSPITAL SUN YAT SEN UNIV
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