Ipilimumab plus nivolumab

A randomized controlled trial compared the combination of ipilimumab and nivolumab with sunitinib. Nivolumab (3 mg/kg) and ipilimumab (1 mg/kg) were given every 3 weeks for four doses, followed by maintenance nivolumab (3 mg/kg) every 2 weeks. Sunitinib was given at a dose of 50 mg once daily for the first 4 weeks of a repeating 6-week cycle (i.e., each cycle consisted of 4 weeks taking the drug, followed by a 2-week break). Treatment continued until disease progression unless adverse events or withdrawal of consent led to discontinuation. The coprimary end points were OS, progression-free survival (PFS), and objective response rate in patients with intermediate- or poor-risk disease. Of note, because there were three primary end points, the overall alpha level of 0.05 was divided among the three end points. This meant that the P-value cutoffs for significance were 0.001 for response rate, 0.009 for PFS, and 0.04 for OS. The trial enrolled 1,096 patients, 847 of whom had intermediate- or poor-risk disease.

A randomized controlled trial compared the combination of ipilimumab and nivolumab with sunitinib. Nivolumab (3 mg/kg) and ipilimumab (1 mg/kg) were given every 3 weeks for four doses, followed by maintenance nivolumab (3 mg/kg) every 2 weeks. Sunitinib was given at a dose of 50 mg once daily for the first 4 weeks of a repeating 6-week cycle (i.e., each cycle consisted of 4 weeks taking the drug, followed by a 2-week break). Treatment continued until disease progression unless adverse events or withdrawal of consent led to discontinuation. The coprimary end points were OS, progression-free survival (PFS), and objective response rate in patients with intermediate- or poor-risk disease. Of note, because there were three primary end points, the overall alpha level of 0.05 was divided among the three end points. This meant that the P-value cutoffs for significance were 0.001 for response rate, 0.009 for PFS, and 0.04 for OS. The trial enrolled 1,096 patients, 847 of whom had intermediate- or poor-risk disease.

With a median follow-up of 25.2 months for intermediate- and poor-risk patients, the 18-month OS rate was 75% in the ipilimumab-plus-nivolumab arm, compared with 60% in the sunitinib arm. Among patients with intermediate- and poor-risk disease, the hazard ratio (HR)death was 0.63 (99.8% confidence interval [CI], 0.44–0.89; P < .001).

A randomized controlled trial compared the combination of ipilimumab and nivolumab with sunitinib. Nivolumab (3 mg/kg) and ipilimumab (1 mg/kg) were given every 3 weeks for four doses, followed by maintenance nivolumab (3 mg/kg) every 2 weeks. Sunitinib was given at a dose of 50 mg once daily for the first 4 weeks of a repeating 6-week cycle (i.e., each cycle consisted of 4 weeks taking the drug, followed by a 2-week break). Treatment continued until disease progression unless adverse events or withdrawal of consent led to discontinuation. The coprimary end points were OS, progression-free survival (PFS), and objective response rate in patients with intermediate- or poor-risk disease. Of note, because there were three primary end points, the overall alpha level of 0.05 was divided among the three end points. This meant that the P-value cutoffs for significance were 0.001 for response rate, 0.009 for PFS, and 0.04 for OS. The trial enrolled 1,096 patients, 847 of whom had intermediate- or poor-risk disease.

There was no statistically significant difference in PFS. Median PFS among patients with intermediate- and poor-risk disease was 11.6 months with ipilimumab plus nivolumab, compared with 8.4 months with sunitinib (HR, 0.82; 99.1% CI, 0.64–1.05).

A randomized controlled trial compared the combination of ipilimumab and nivolumab with sunitinib. Nivolumab (3 mg/kg) and ipilimumab (1 mg/kg) were given every 3 weeks for four doses, followed by maintenance nivolumab (3 mg/kg) every 2 weeks. Sunitinib was given at a dose of 50 mg once daily for the first 4 weeks of a repeating 6-week cycle (i.e., each cycle consisted of 4 weeks taking the drug, followed by a 2-week break). Treatment continued until disease progression unless adverse events or withdrawal of consent led to discontinuation. The coprimary end points were OS, progression-free survival (PFS), and objective response rate in patients with intermediate- or poor-risk disease. Of note, because there were three primary end points, the overall alpha level of 0.05 was divided among the three end points. This meant that the P-value cutoffs for significance were 0.001 for response rate, 0.009 for PFS, and 0.04 for OS. The trial enrolled 1,096 patients, 847 of whom had intermediate- or poor-risk disease.

The objective response rate was higher with ipilimumab plus nivolumab than with sunitinib (42% vs. 27%, P < .001). In the ipilimumab-plus-nivolumab arm, 40 patients (9%) had complete responses, compared with 5 patients (1%) in the sunitinib arm.