Renal Cell Carcinoma Outcomes Improved with Combination Immunotherapy

Combination therapy with nivolumab and ipilimumab was associated with improved response rates in patients with metastatic renal cell carcinoma, according to the results of a recent study.
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In their open-label, parallel-cohort, dose-escalation, phase I study, the researchers assigned patients to receive intravenous nivolumab 3 mg/kg plus ipilimumab 1 mg/kg (N3I1), nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (N1I3), or nivolumab 3 mg/kg plus ipilimumab 3 mg/kg (N3I3) every 3 weeks for 4 doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks until progression or toxicity. End points of the study included safety, objective response rate, and overall survival.

Patients in the N3I3 arm of the study were censored at time of analysis, due to dose-limiting toxicity or other reasons. Overall, 47 participants were treated in the N3I1 and the N1I3 arms. Grade 3 and 4 treatment-related adverse events were reported in 38.3% and 61.7% of the N3I1 and N1I3 arms, respectively. Objective response rate was 40.4% in both arms after a median follow-up of 22.3 months, and ongoing responses were 42.1% and 36.8% in the N3I1 and N1I3 arms, respectively. Two-year overall survival was 67.3% and 69.6% in the N3I1 and N1I3 arms, respectively.

“Although the N3I1 and N1I3 combination therapies were similarly efficacious, the overall safety results support additional clinical development of N3I1,” the authors concluded.

“Relative to the other arms, patients who received the N3I1 combination regimen had lower rates of treatment-related adverse events (all, and grade 3 or 4), lower rates of serious adverse events, and lower rates of select treatment-related adverse events in a majority of categories. Furthermore, fewer patients in the N3I1 arm discontinued as a result of a treatment-related adverse events, and fewer patients required an IMM to manage adverse events.”

—Michael Potts

Reference:

Hammers HJ, Plimack ER, Infante JR, et al. Safety and efficacy of nivolumab in combination with ipilimumab in metastatic renal cell carcinoma: the Checkmate 016 study [published online July 5, 2017]. Journal of Clinical Oncology. DOI: 10.1200/JCO.2016.72.1985.