Combined pharmaceutical composition for treating small cell lung cancer

Patent metadata

Field	Value
Publication number	US-12527784-B2
Application number	US-202017438804-A
Country	US
Kind code	B2
Filing date	Mar 13, 2020
Priority date	Mar 15, 2019
Publication date	Jan 20, 2026
Grant date	Jan 20, 2026

Abstract

The present invention relates to the field of biomedicine and relates to a combined pharmaceutical composition used for treating small cell lung cancer, the composition comprising an anti-PD-L1 antibody and anlotinib, and having good anti-small cell lung cancer activity.

First claim

What is claimed is:

1 . A method for treating small cell lung cancer, comprising administering to a subject an effective amount of an anti-PD-L1 antibody and anlotinib, wherein the anti-PD-L1 antibody comprises an amino acid sequence as follows: a heavy chain CDR1 region selected from the group consisting of SEQ ID NO: 1; a heavy chain CDR2 region selected from the group consisting of SEQ ID NO: 2; a heavy chain CDR3 region selected from the group consisting of SEQ ID NO: 3; a light chain CDR1 region selected from the group consisting of SEQ ID NO: 7; a light chain CDR2 region selected from the group consisting of SEQ ID NO: 8; and a light chain CDR3 region selected from the group consisting of SEQ ID NO: 9.

2 . The method according to claim 1 , wherein the method comprises administering a combination of the anti-PD-L1 antibody and anlotinib.

3 . The method according to claim 1 , wherein the anti-PD-L1 antibody and anlotinib are each in the form of a pharmaceutical composition that can be administered simultaneously, sequentially or at intervals.

4 . The method according to claim 1 , wherein the anti-PD-L1 antibody is administered once every week, every 2 weeks, every 3 weeks, or every 4 weeks.

5 . The method according to claim 4 , wherein the anti-PD-L1 antibody is administered at a dose of 600-2400 mg each time.

6 . The method according to claim 1 , wherein anlotinib is administered at a dose of 6 mg, 8 mg, 10 mg, or 12 mg once daily with a regimen of continuous 2-week treatment plus 1-week interruption.

7 . The method according to claim 3 , wherein the method comprises administering a pharmaceutical composition containing 600-2400 mg of the anti-PD-L1 antibody and a pharmaceutical composition containing anlotinib in a single dose of 6 mg, 8 mg, 10 mg and/or 12 mg.

8 . The method according to claim 1 , wherein the anti-PD-L1 antibody and anlotinib are packaged either separately or together.

9 . The method according to claim 1 , wherein the anti-PD-L1 antibody comprises an amino acid sequence as follows: a heavy chain variable region having at least 80% homology to an amino acid sequence set forth in SEQ ID NO: 13; and a light chain variable region having at least 80% homology to an amino acid sequence set forth in SEQ ID NO: 15.

10 . The method according to claim 1 , wherein the anti-PD-L1 antibody comprises an amino acid sequence as follows: a heavy chain amino acid sequence set forth in SEQ ID NO: 17; and a light chain amino acid sequence set forth in SEQ ID NO: 18.

11 . The method according to claim 1 , wherein a treatment cycle takes 21 days; 1200 mg of the anti-PD-L1 antibody is administered on the first day of each treatment cycle, and 6 mg, 8 mg, 10 mg or 12 mg of anlotinib is administered daily on days 1-14 of each treatment cycle.

12 . The method according to claim 1 , wherein the small cell lung cancer comprises limited-stage and extensive-stage small cell lung cancer;
the small cell lung cancer is recurrent and/or metastatic small cell lung cancer; or the small cell lung cancer is advanced/metastatic small cell lung cancer.

13 . The method according to claim 9 , wherein the anti-PD-L1 antibody comprises: a heavy chain variable region having an amino acid sequence set forth in SEQ ID NO: 13, and a light chain variable region having an amino acid sequence set forth in SEQ ID NO: 15.

Assignees

• Chia Tai Tianqing Pharmaceutical Group Co Ltd
• Nanjing Shunxin Pharmaceuticals Co Ltd Of Chiatai Tianqing Pharmaceutical Group
• Chia Tai Tianqing Pharmaceutical Group Co Ltd And

Inventors

• Wang Shanchun
• Wang Xunqiang
• Yu Ding
• Liu Wenwen
• Shu Chao
• Fan Mengxue

Classifications

• A61K39/3955

  against proteinaceous materials, e.g. enzymes, hormones, lymphokines · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61P35/00 Primary

  Antineoplastic agents · CPC title

• A61K2039/505

  comprising antibodies · CPC title

• A61K39/39558

  against tumor tissues, cells, antigens · CPC title