Approach for treatment of cancer via immunomodulation by using talabostat
The present invention discloses a method of treating, preventing or ameliorating tumor growth by administering a therapeutic agent that selectively inhibits dipeptidyl peptidase including fibroblast activation protein and dipeptidyl peptidase 8/9 in combination with an immune checkpoint inhibitor. The method specifically discloses use of Talabostat in combination with an immune checkpoint inhibitor, its pharmaceutical composition and process of preparing such composition.
1. A method of treating prostate cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of Talabostat or a pharmaceutically acceptable salt thereof in combination with an anti-PD-1 antibody, wherein the prostate cancer is metastatic castration-resistant prostate cancer, wherein the anti-PD-1 antibody is Pembrolizumab, and wherein the therapeutically effective amount of Talabostat or a pharmaceutically acceptable salt thereof is 400 micrograms to 600 micrograms per day.
2. The method according to claim 1 , wherein the Pembrolizumab is administered at a dose from 0.01 mg/kg to 30 mg/kg.
3. The method according to claim 1 , wherein the Pembrolizumab is administered at a dose from 0.1 mg/kg to 5 mg/kg.
4. The method according to claim 1 , wherein Talabostat or the pharmaceutically acceptable salt thereof is administered simultaneously, sequentially or intermittently with the anti-PD-1 antibody.
5. The method according to claim 1 , wherein Talabostat or the pharmaceutically acceptable salt thereof is Talabostat mesylate.
6. The method according to claim 5 , wherein Talabostat mesylate is administered simultaneously, sequentially or intermittently with the anti-PD-1 antibody.
7. The method according to claim 1 comprising a therapeutic effect of an inhibition of tumor size of at least 50%.
8. The method of claim 1 , wherein Talabostat or a pharmaceutically acceptable salt thereof is administered at a dose of 600 micrograms per day.
9. The method of claim 8 , wherein Talabostat or a pharmaceutically acceptable salt thereof is administered at a dose of 300 micrograms twice per day.