Therapeutic combination of quinoline derivative and antibody
The present application provides a therapeutic combination of a quinoline derivative and an antibody, which comprises an immune checkpoint inhibitor and a tyrosine kinase inhibitor, wherein the tyrosine kinase inhibitor is a compound of formula I or a pharmaceutically acceptable salt thereof. The therapeutic combination in the present application shows good activity against lung tumor and liver tumor.
1. A therapeutic combination, comprising:
a) an inhibitor for the interaction between PD-1 and its ligand PD-L1, wherein the inhibitor is an anti-PD-1 antibody or an antigen-binding fragment thereof, and wherein the anti-PD-1 antibody is sintilimab and
b) a tyrosine kinase inhibitor, wherein the tyrosine kinase inhibitor is a compound of formula I or a pharmaceutically acceptable salt thereof,
2. The therapeutic combination according to claim 1 , wherein the pharmaceutically acceptable salt of the compound of formula I is 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy]methyl]cyclopropylamine hydrochloride.
3. The therapeutic combination according to claim 1 , comprising: a dihydrochloride of the compound of formula I; and sintilimab or an antigen-binding fragment thereof.
4. A method for treating cancer in an entity, comprising administering to the entity the therapeutically effective amount of a therapeutic combination according to claim 1 , wherein the cancer is non-small cell lung cancer.
5. The method according to claim 4 , wherein the anti-PD-1 antibody is administered about once a week (q1w), about once every 2 weeks (q2w), about once every 3 weeks (q3w), or about once every 4 weeks (q4w).
6. The method according to claim 4 , wherein the non-small cell lung cancer is driver gene-negative.
7. The method according to claim 6 , wherein 1, 2 or 3 of EGFR, ALK and ROS1 genes are mutation-negative.
8. The method according to claim 6 , wherein the cancer is recurrent and/or metastatic non-small cell lung cancer or locally advanced non-small cell lung cancer.
9. The method according to claim 4 , wherein the method is a first-line treatment for recurrent or metastatic non-small cell lung cancer.
10. The method according to claim 8 , wherein the non-small cell lung cancer is lung adenocarcinoma, squamous cell carcinoma of lung, or large cell lung carcinoma.
11. The method according to claim 4 , wherein the compound of formula I or the pharmaceutically acceptable salt thereof is administered according to a treatment cycle of 2 weeks (14 days) of treatment plus 1 week (7 days) of interruption.
12. The method according to claim 4 , wherein the therapeutic combination administered per treatment cycle comprises about 84-168 mg of the compound of formula I or the pharmaceutically acceptable salt thereof.
13. The method according to claim 4 , wherein 100-600 mg of the anti-PD-1 antibody is administered about once every 2 weeks (q2w) or about once every 3 weeks (q3w).
14. The method according to claim 4 , wherein the anti-PD-1 antibody or the antigen-binding fragment thereof and the tyrosine kinase inhibitor are each in the form of a pharmaceutical composition and can be administered simultaneously, sequentially, or at intervals.