Compared with sunitinib, nivolumab plus ipilimumab may reduce the risk of death by 37% among treatment-naive patients with advanced renal cell carcinoma (RCC), according to findings published in The New England Journal of Medicine.1
Previous studies showed that combination therapy with nivolumab and ipilimumab has promising efficacy for various cancers, including RCC, compared with either agent alone.
For the open-label, phase 3 CheckMate 214 study (ClinicalTrials.gov Identifier: NCT02231749), researchers randomly assigned 1096 previously untreated patients to receive intravenous (IV) nivolumab 3 mg/kg plus IV ipilimumab 1 mg/kg or oral sunitinib 50 mg monotherapy, the standard first-line treatment for RCC. Patients were characterized by their International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk; 425 were considered intermediate-risk and 422 poor-risk.
After a median follow-up of 25.2 months, the 18-month overall survival (OS) rate among patients with intermediate- or poor-risk disease in the nivolumab plus ipilimumab arm was 75% (95% CI, 70%-78%) vs 60% (95% CI, 55%-65%) in the sunitinib arm. The median OS was 26.0 months in the sunitinib arm and was not reached in the combination arm (hazard ratio [HR] for death, 0.63; P < .001).
The objective response rate (ORR) was 42% vs 27% for the combination arm vs the sunitinib arm (P < .001), respectively, and the complete response rates were 9% and 1%, respectively. Patients treated with nivolumab and ipilimumab had a non-significant median progression-free survival improvement of 11.6 months vs 8.4 months for sunitinib-treated patients (HR, 0.82; P = .03; significance threshold was .009).
There was a lower incidence of treatment-related adverse events (AEs) in the nivolumab plus ipilimumab arm: 93% of patients experienced an AE compared with 97% of patients in the sunitinib arm, and 46% vs 63% experienced a grade 3 to 4 AE, respectively.
The authors concluded that “this trial showed an efficacy and overall survival benefit of nivolumab plus ipilimumab over sunitinib in the first-line treatment of intermediate- or poor-risk advanced clear-cell renal-cell carcinoma.”
- Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med. 2018 Mar 21. doi: 10.1056/NEJMoa1712126 [Epub ahead of print]