CheckMate 214: Nivolumab Plus Ipilimumab Versus Sunitinib for aRCC

The phase 3 CheckMate 214 trial led by Nizar M. Tannir, MD, FACP, and presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium investigated the potential long-term benefits of nivolumab plus ipilimumab versus sunitinib alone for patients with advanced renal cell carcinoma (aRCC).

Researchers randomized patients following a 1:1 ratio to receive either nivolumab 3 mg plus ipilimumab 1 mg every 3 weeks for 4 cycles or sunitinib 50 mg once per day for 4 weeks on and 2 weeks off.

The study’s end points included overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in patients categorized with intermediate or poor risk in the International mRCC Database Consortium (IMDC), intent to treat (ITT), and favorable risk.

Patients with intermediate or poor risk and ITT patients saw improved OS rates when receiving nivolumab plus ipilimumab compared with sunitinib. For favorable-risk patients, OS rates remained similar across both cohorts.

In the nivolumab-plus-ipilimumab group, ORR per independent radiology review committee was higher than in the sunitinib group, with increased ongoing responses in ITT (60% vs 50%, respectively) and intermediate- or poor-risk (60% vs 50%, respectively) patients. Favorable-risk patients demonstrated lower ORRs in the nivolumab-plus-ipilimumab cohort versus the sunitinib cohort (59% vs 52%, respectively), but more responses are ongoing.

The median duration of response was longer and the complete response rate was higher in the nivolumab-plus-ipilimumab cohort versus the sunitinib cohort regardless of IMDC risk group.

Dr. Tannir and colleagues concluded that treatment with nivolumab plus ipilimumab led to increased long-term survival and durable response benefits in patients with aRCC when compared with sunitinib alone.

Researchers observed no new safety signals.