Apilimod for use in the treatment of renal cancer
View Patent ↗The present disclosure relates to methods for treating renal cancer with apilimod and related compositions and methods.
1. A method for treating clear cell renal carcinoma in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of apilimod dimesylate in combination with a vascular endothelial growth factor (VEGF) inhibitor.
2. The method of claim 1 , further comprising administering at least one additional active agent.
3. The method of claim 2 , wherein the at least one additional active agent is a therapeutic agent or a non-therapeutic agent, or a combination thereof.
4. The method of claim 3 , wherein the therapeutic agent is selected from the group consisting of a protein kinase inhibitor, a PD-1/PDL-1 pathway inhibitor, a checkpoint inhibitor, a platinum based anti-neoplastic agent, a topoisomerase inhibitor, a nucleoside metabolic inhibitor, an alkylating agent, an intercalating agent, a tubulin binding agent, and combinations thereof.
5. The method of claim 4 , wherein the therapeutic agent is a protein kinase inhibitor.
6. The method of claim 1 , wherein the VEGF inhibitor is pazopanib or sorafenib, or a combination thereof.
7. The method of claim 4 , wherein the therapeutic agent is a PD-1/PDL-1 pathway inhibitor.
8. The method of claim 7 , wherein the therapeutic agent is selected from pembrolizumab, avelumab, atezolizumab (MPDL3280A), nivolurnab (BMS-936558), pidilizumab (MK-3475), MSB0010718C, and MEDI4736.
9. The method of claim 1 further comprising administering a non-therapeutic agent selected to ameliorate one or more side effects of the apilimod.
10. The method of claim 9 , wherein the non-therapeutic agent is selected from the group consisting of ondanestron, granisetron, dolsetron, and palonosctron.
11. The method of claim 9 , wherein the non-therapeutic agent is selected from the group consisting of pindolol and risperidone.
12. The method of claim 1 , wherein the therapeutically effective amount of the apilimod dimesylate is the amount effective to inhibit PIKfyve kinase activity in cancer cells of the subject.
13. The method of claim 1 , wherein the clear cell renal carcinoma is refractory to standard treatment or is metastatic.
14. The method of claim 1 , wherein the composition is in a form suitable for oral or intravenous administration.
15. The method of claim 1 , wherein the VEGF inhibitor is selected from the group consisting of bevacizumab, sunitinib, pazopanib, axitinib, sorafenib, regorafenib, lenvatinib, motesanib, and vandetanib.