Combination for the treatment of renal cancer
The combination of anti-PD-L1 antibody and anlotinib overcomes the limitations of existing treatments for renal cell carcinoma, providing a more effective treatment option and enhancing the therapeutic effect on renal cell carcinoma.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- CHIA TAI TIANQING PHARMA GRP CO LTD
- Filing Date
- 2021-04-30
- Publication Date
- 2026-06-16
AI Technical Summary
Current treatments for kidney cancer are not sensitive to radiotherapy and chemotherapy, and while existing targeted therapies are effective, other treatment options need to be explored to improve prognosis.
A pharmaceutical combination of an anti-PD-L1 antibody and anlotinib or a pharmaceutically acceptable salt thereof, administered via different routes and regimens, is used to treat renal cell carcinoma.
It has enhanced the treatment effect on kidney cancer, provided new treatment options, and improved patients' survival rate and quality of life.
Smart Images
Figure PCTCN2021091592-APPB-000001 
Figure PCTCN2021091592-APPB-000002 
Figure PCTCN2021091592-APPB-000003
Abstract
Claims
1. Use of an anti-PD-Ll antibody in combination with anlotinib, or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for treating advanced renal cell carcinoma, wherein, The anti-PD-L1 antibody comprises: a heavy chain CDR1 region of the amino acid sequence shown in SEQ ID NO:1, a heavy chain CDR2 region of the amino acid sequence shown in SEQ ID NO:2, a heavy chain CDR3 region of the amino acid sequence shown in SEQ ID NO:3; a light chain CDR1 region of the amino acid sequence shown in SEQ ID NO:7, a light chain CDR2 region of the amino acid sequence shown in SEQ ID NO:8, and a light chain CDR3 region of the amino acid sequence shown in SEQ ID NO:
9.
2. Use according to claim 1, wherein, The anti-PD-L1 antibody and anlotinib or a pharmaceutically acceptable salt thereof are each in the form of a pharmaceutical composition and are administered simultaneously, sequentially or at intervals.
3. The use according to claim 2, wherein, The anti-PD-L1 antibody and anlotinib or a pharmaceutically acceptable salt thereof are administered at intervals.
4. The use according to claim 1, comprising administering to a patient in need: a pharmaceutical composition containing 600-2400 mg of an anti-PD-L1 antibody, and a pharmaceutical composition of anlotinib or a pharmaceutically acceptable salt thereof in unit doses of 6 mg, 8 mg, 10 mg and / or 12 mg.
5. The use according to claim 1, wherein, The anti-PD-L1 antibody is administered once every 3 weeks.
6. The use according to claim 5, wherein, The anti-PD-L1 antibody is administered at a dose of 600–2400 mg each time.
7. The use according to claim 6, wherein, The anti-PD-L1 antibody is administered at a dose of 1200 mg each time.
8. The use according to claim 2, wherein, The pharmaceutical composition of the anti-PD-L1 antibody is an injectable solution.
9. The use according to claim 1, wherein, The anti-PD-L1 antibody is prepared into a pharmaceutical composition, wherein the concentration of the anti-PD-L1 antibody in the pharmaceutical composition is 10–60 mg / mL.
10. The use according to claim 9, wherein, The concentration of the anti-PD-L1 antibody in the pharmaceutical composition is 30 mg / mL.
11. The use according to claim 1, wherein, The anti-PD-L1 antibody is administered via intravenous infusion.
12. The use according to claim 1, wherein a treatment cycle is 21 days, the PD-L1 antibody is administered on the first day of each treatment cycle, and anlotinib or a pharmaceutically acceptable salt thereof is administered daily from day 1 to day 14 of each cycle.
13. The use according to claim 12, wherein 1200 mg of PD-L1 antibody is administered on the first day of each treatment cycle, and 6 mg, 8 mg, 10 mg and / or 12 mg of anlotinib or a pharmaceutically acceptable salt thereof is administered daily on days 1-14 of each treatment cycle.
14. The use according to claim 1, wherein, The renal cell carcinoma is either clear cell renal cell carcinoma or non-clear cell renal cell carcinoma.
15. The use according to claim 1, wherein, The renal cell carcinoma is a clear cell type renal cell carcinoma, or a renal cell carcinoma with clear cell components as the main component.
16. The use according to claim 1, wherein, The kidney cancer mentioned is advanced renal cell carcinoma.
17. The use according to claim 1, wherein, The renal cell carcinoma mentioned is a newly diagnosed, advanced renal cell carcinoma.
18. The use according to claim 1, wherein, The renal cell carcinoma referred to is renal cell carcinoma that has not received prior systematic treatment.
19. The use according to claim 1, wherein, The renal cell carcinoma referred to is advanced renal cell carcinoma that has not received prior systematic treatment.
20. The use according to claim 1, wherein, The renal cell carcinoma is an unresectable or metastatic advanced renal cell carcinoma.
21. The use according to any one of claims 1-20, wherein, The anti-PD-L1 antibody comprises: a heavy chain variable region having at least 80% homology with the amino acid sequence shown in SEQ ID NO:13; and a light chain variable region having at least 80% homology with the amino acid sequence shown in SEQ ID NO:
15.
22. The use according to any one of claims 1-20, wherein, The anti-PD-L1 antibody comprises: a heavy chain variable region as shown in SEQ ID NO:13; and a light chain variable region as shown in SEQ ID NO:
15.
23. The use according to any one of claims 1-20, wherein, The anti-PD-L1 antibody comprises: The heavy chain amino acid sequence as shown in SEQ ID NO:17; the light chain amino acid sequence as shown in SEQ ID NO:18, or The heavy chain amino acid sequence is shown in SEQ ID NO:21; the light chain amino acid sequence is shown in SEQ ID NO:
18.
24. The use according to any one of claims 1-20, wherein, The anti-PD-L1 antibody comprises: The heavy chain amino acid sequence is shown in SEQ ID NO:17; the light chain amino acid sequence is shown in SEQ ID NO:18.