Real-world efficacy and tolerability of axitinib + pembrolizumab in the treatment of renal cell carcinoma

Combination therapy with immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor tyrosine kinase inhibitors (VEGF TKIs) is standard of care for metastatic renal cell carcinoma (mRCC); however, no head-to-head trials have compared FDA-approved regimens. This project aims to provide real-world data on the safety and efficacy of axitinib + pembrolizumab in the treatment of mRCC and describe management of common treatment-related adverse events. This is a retrospective, observational, quality improvement project conducted at the Robert H Lurie Comprehensive Cancer Center of Northwestern University in Chicago, Illinois. Patients 18 years of age or older with stage IV RCC who received axitinib + pembrolizumab between April 2019 and February 2024 were included. Endpoints included progression-free survival (PFS), overall survival (OS), duration of treatment, subsequent therapies, and safety outcomes. Thirty-one patients received axitinib + pembrolizumab for mRCC. With a median follow-up time of 22.6 months, PFS was 37.4 months and OS was not reached. Ninety-four percent of patients experienced a treatment-related adverse event with 32.3% classified as grade 3 or higher. Fifty two percent of patients required axitinib dose reductions, 70.9% had at least one axitinib dose held, and 70.9% had at least one pembrolizumab dose held. Patients with axitinib dose reductions demonstrated improved OS at one year (92.9% vs. 80%). This retrospective study corroborates the findings of the KEYNOTE-426 trial and further demonstrates the effectiveness of axitinib + pembrolizumab combination therapy in the treatment of mRCC. Dose reductions and holds do not appear to impact treatment efficacy.