Nivolumab and Salvage Nivolumab Plus Ipilimumab for aRCC: Outcomes From a Phase 2 Study

A research team assessed treatment-free survival (TFS) outcomes from HCRN GU16-260, a study on frontline therapy using nivolumab and salvage nivolumab plus ipilimumab in patients with advanced renal cell carcinoma (aRCC) to reduce toxicity and cap immunotherapy duration. They presented their findings at the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium.

Data were analyzed from 128 patients with clear cell aRCC who were treated with first-line nivolumab monotherapy for up to 2 years. Salvage nivolumab/ipilimumab was also provided for up to 1 year to eligible patients with disease progression at any point or stable disease at 48 weeks (28% of patients).

TFS was defined in this study as the area between Kaplan-Meier curves for time from registration to protocol therapy cessation and for time from registration to subsequent therapy initiation or death, estimated from 36-month mean times. The time on treatment or off treatment with grade 3+ treatment-related adverse events (TRAEs) was also captured.

At 36 months after enrollment, 68.3% of patients were alive (96.8% of International mRCC Database Consortium favorable-risk (FAV) points and 56.6% of patients with intermediate/poor risk [I/P]). The 36-month mean time for protocol therapy was 11.5 months (16.0 months for FAV patients and 9.6 months for I/P patients). The 36-month mean TFS for the full population was 9.4 months. For FAV patients, the mean TFS was 12.9 months, and the TFS for those patients with grade 3+ TRAEs was 1.5 months. For I/P patients, the mean TFS was 8.0 months, and the TFS for those patients with grade 3+ TRAEs was 1.0 months. At 36 months, 65.6% of FAV patients and 27.1% of I/P patients were alive and second-line treatment-free.

Nivolumab monotherapy with salvage nivolumab/ipilimumab used in nonresponders is an active approach in treatment-naïve patients with aRCC, resulting in substantial and toxicity-free TFS. TFS was distinct in patients with FAV disease, which further supports the use of an immunotherapy-only regimen in this patient population.