- Results from the phase 3b/4 CheckMate 511 trial suggest that a dosing regimen of nivolumab 3 mg/kg plus ipilimumab 1 mg/kg (NIVO3+IPI1) is associated with improved safety but similar efficacy compared with nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (NIVO1+IPI3) for patients with unresectable stage III/IV melanoma.
Why this matters
- These results suggest a superior safety profile for NIVO3+IPI1.
- Patients treated with NIVO3+IPI1 had lower incidence of grade 3-5 treatment-related adverse events (TRAEs) compared with patients treated with NIVO1+IPI3 (33.9% vs 48.3%; P=.006; primary endpoint).
- NIVO3+IPI1 and NIVO1+IPI3 were associated with similar objective response rates (45.6% vs 50.6%, respectively; P=.35).
- NIVO3+IPI1 and NIVO1+IPI3 were associated with similar median PFS (9.92 vs 8.94 months; HR, 1.06; 95% CI, 0.79-1.42) and OS (not reached for both; HR, 1.09; 95% CI, 0.73-1.62).
- 360 patients with previously untreated, unresectable stage III/IV melanoma were randomly assigned 1:1 to NIVO3+IPI1 or NIVO1+IPI3 once every 3 weeks for 4 doses.
- 6 weeks after the last combination dose, patients received NIVO 480 mg once every 4 weeks until progression or unacceptable toxicity.
- Funding: Bristol-Myers Squibb and ONO Pharmaceutical Company.
- Study not designed to formally demonstrate noninferiority for efficacy endpoints.