Everolimus is a potent oral inhibitor of mTOR kinase, involved in the regulation of cell growth, proliferation and survival, and angiogenesis, and mTOR dysfunction has been implicated in the pathogenesis of renal cell carcinoma (RCC). This drug is the standard of care for patients with metastatic RCC (mRCC) progressing after previous treatment with vascular endothelial growth factor receptor (VEGFR-TKI) tyrosine kinase inhibitors.
The efficacy of everolimus in this class was demonstrated in the RECORD-1 study - the median progression-free survival (PFS) was prolonged to 4.9 months (vs. 1.9 months in the placebo arm) and the risk of progression was reduced by 67 % (HR: 0.33; p <0.001). However, it is not yet known whether and to what extent the results of everolimus treatment differ between two VEGFR-TKIs.