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Comparing Nivolumab, Ipilimumab With Sunitinib for the First-Line Treatment of Advanced RCC

By Katy Marshall - Last Updated: August 5, 2024

Prior research has demonstrated that patients with advanced renal cell carcinoma (aRCC) who underwent treatment with nivolumab plus ipilimumab experienced increased overall survival (OS) and durable response benefits compared with those who received sunitinib.

A study from Nizar M. Tannir, MD, and colleagues published in Annals of Oncology reported 8-year follow-up data from the phase 3 CheckMate 214 trial.

In CheckMate 214, patients received either nivolumab 3 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 3 mg/kg or sunitinib 50 mg. The study’s end points included OS, independent radiology review committee-assessed progression-free survival (PFS), and objective response rate in intermediate-/poor-risk (I/P), intent-to-treat (ITT), and favorable-risk (FAV) patients.

After an 8-year follow-up period, the hazard ratio for OS with nivolumab plus ipilimumab compared with sunitinib was 0.69 in I/P patients, 0.72 in ITT patients, and 0.82 in FAV patients. At 90 months, the PFS probabilities were 25.4% versus 8.5% in the I/P group, 22.8% versus 10.8% in the ITT group, and 12.7% versus 17.0% in the FAV group, respectively.

Across all risk groups, patients who received nivolumab plus ipilimumab experienced increased complete response rates compared with those in the sunitinib cohort. The median duration of response for patients who received nivolumab plus ipilimumab compared with the sunitinib group was 82.8 versus 19.8 months in the I/P cohort, 76.2 months versus 25.1 months in the ITT cohort, and 61.5 versus 33.2 months in the FAV cohort.

“Superior survival, durable response benefits, and a manageable safety profile were maintained with [nivolumab plus ipilimumab versus sunitinib] at 8 years, the longest phase 3 follow-up for a first-line checkpoint inhibitor combination therapy in aRCC,” the researchers wrote.