Apilimod for use in the treatment of renal cancer

Abstract

The present disclosure relates to methods for treating renal cancer with apilimod and related compositions and methods.

1 - 22 . (canceled) 
     
     
         23 . 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 or a pharmaceutically acceptable salt thereof. 
     
     
         24 . The method of  claim 23 , further comprising administering at least one additional active agent. 
     
     
         25 . The method of  claim 24 , wherein the at least one additional active 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. 
     
     
         26 . The method of  claim 25 , wherein the at least one additional active agent is a protein kinase inhibitor. 
     
     
         27 . The method of  claim 26 , wherein the protein kinase inhibitor is a vascular endothelial growth factor (VEGF) inhibitor. 
     
     
         28 . The method of  claim 27 , wherein the VEGF inhibitor is selected from the group consisting of bevacizumab, sunitinib, pazopanib, axitinib, sorafenib, regorafenib, lenvatinib, motesanib, and vandetanib. 
     
     
         29 . The method of  claim 28 , wherein the VEGF inhibitor is pazopanib or sorafenib, or a combination thereof. 
     
     
         30 . The method of  claim 25 , wherein the at least one additional active agent is a PD-1/PDL-1 pathway inhibitor. 
     
     
         31 . The method of  claim 30 , wherein the PD-1/PDL-1 pathway inhibitor agent is selected from pembrolizumab, avelumab, atezolizumab (MPDL3280A), nivolumab (BMS-936558), pidilizumab (MK-3475), MSB0010718C, and MEDI4736. 
     
     
         32 . The method of  claim 23 , wherein the clear cell renal carcinoma is refractory to standard treatment or is metastatic. 
     
     
         33 . The method of  claim 23 , wherein the composition is in a form suitable for oral or intravenous administration. 
     
     
         34 . The method of  claim 23 , wherein the pharmaceutically acceptable salt is selected from sulfate, citrate, acetate, oxalate, chloride, bromide, iodide, nitrate, bisulfate, phosphate, acid phosphate, isonicotinate, lactate, salicylate, acid citrate, tartrate, oleate, tannate, pantothenate, bitartrate, ascorbate, succinate, maleate, besylate, gentisinate, fumarate, gluconate, glucaronate, saccharate, formate, benzoate, glutamate, methanesulfonate, ethanesulfonate, benzenesulfonate, p-toluenesulfonate, and pamoate (e.g., 1,1′-methylene-bis-(2-hydroxy-3-naphthoate). 
     
     
         35 . The method of  claim 34 , wherein the pharmaceutically acceptable salt is selected from chloride, phosphate, lactate, tartrate, maleate, fumarate, methanesulfonate, and pamoate.