Drug for treating locally advanced unresectable or metastatic colorectal cancer and use thereof
AssigneeShenzhen Chipscreen Biosciences Co., Ltd.
InventorsXianping LU, Desi PAN, Xiaoning WANG
Life of this patent
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Abstract
A drug for treating locally advanced unresectable or metastatic colorectal cancer and a use thereof. Compared with the solution of a two-drug combination of Sintilimab+Chidamide, the provided solution of a three-drug combination of Sintilimab+Chidamide+IBI305 can significantly prolong the progress-free survival of a patient with MSS/MSI-L locally advanced unresectable or metastatic colorectal cancer. Additionally, in terms of ORR, PR, PD, NE, DCR, etc., the three-drug combination of Sintilimab+Chidamide+IBI305 can also significantly benefit the patient with MSS/MSI-L locally advanced unresectable or metastatic colorectal cancer.
Claims10
Use of chidamide or a derivative thereof in combination with a component (2) and a component (3) in third-line or higher-line prevention and/or treatment and/or amelioration of a locally advanced unresectable or metastatic colorectal cancer disease or disease progression, wherein
- the derivative of chidamide is a pharmaceutically acceptable salt, crystal form, isomer, prodrug, or metabolite of chidamide;
- the component (2) is selected from the group consisting of sintilimab, an antigen-binding fragment thereof, a variant thereof, and a biosimilar thereof, and
- the component (3) is selected from the group consisting of bevacizumab, an antigen-binding fragment thereof, a variant thereof, and a biosimilar thereof.
Use of chidamide or a derivative thereof in manufacture of a combined medicament for third-line or higher-line prevention and/or treatment and/or amelioration of a locally advanced unresectable or metastatic colorectal cancer disease or disease progression, wherein the combined medicament comprises chidamide or a derivative thereof and further comprises a component (2) and a component (3), wherein:
- the derivative of chidamide is a pharmaceutically acceptable salt, crystal form, isomer, prodrug, or metabolite of chidamide;
- the component (2) is selected from the group consisting of sintilimab, an antigen-binding fragment thereof, a variant thereof, and a biosimilar thereof, and
- the component (3) is selected from the group consisting of bevacizumab, an antigen-binding fragment thereof, a variant thereof, and a biosimilar thereof.
A pharmaceutical composition for use in third-line and higher-line prevention and/or treatment and/or amelioration of a locally advanced unresectable or metastatic colorectal cancer disease or disease progression, comprising a component (1), a component (2), and a component (3), wherein
- the component (1) is selected from the group consisting of chidamide, a pharmaceutically acceptable salt, crystal form, isomer, prodrug, and metabolite thereof,
- the component (2) is selected from the group consisting of sintilimab, an antigen-binding fragment thereof, a variant thereof, and a biosimilar thereof, and
- the component (3) is selected from the group consisting of bevacizumab, an antigen-binding fragment thereof, a variant thereof, and a biosimilar thereof,
- preferably, the colorectal cancer is of a microsatellite stability (MSS) type or a low microsatellite instability (MSI-L) type;
- preferably, the colorectal cancer is of a microsatellite stability (MSS) type;
- preferably, the colorectal cancer is of a low microsatellite instability (MSI-L) type;
- preferably, the colorectal cancer is colorectal adenocarcinoma;
- preferably, the colorectal adenocarcinoma is of a non-adenosquamous-mixed carcinoma type;
- preferably, the colorectal cancer has at least previously undergone failed second-line and higher-line standard treatment or intolerance to toxicity of second-line and higher-line standard treatment;
- preferably, the standard treatment comprises fluorouracils, oxaliplatin, or irinotecan, the fluorouracils comprising 5-fluorouracil, capecitabine, tegafur, and the like;
- preferably, the colorectal cancer has not been previously treated with a small-molecule anti-angiogenic medicament;
- preferably, the component (1) is selected from chidamide or a pharmaceutically acceptable salt or crystal form thereof,
- further preferably, the component (1) is selected from the group consisting of chidamide, and crystal forms A and B thereof,
- further preferably, the component (1) is selected from chidamide;
- preferably, the component (2) is selected from the group consisting of sintilimab, an antigen-binding fragment thereof, and a biosimilar thereof,
- further preferably, the component (2) is selected from sintilimab;
- preferably, the component (3) is selected from the group consisting of bevacizumab, an antigen-binding fragment thereof, and a biosimilar thereof,
- further preferably, the component (3) is selected from the group consisting of bevacizumab and a biosimilar thereof, and
- more preferably, the component (3) is selected from the group consisting of bevacizumab and IBI305.
Dependencies are inferred from the claim text.