The dual primary end points were overall survival and progression-free survival. The key secondary end point was the objective response rate (complete response +partial response). Other secondary end points included duration of response and safety. Efficacy was assessed in the intention-to-treat population, which included all patients who underwent randomization. Safety was assessed in the as-treated population, which included all randomly assigned patients who received one or more doses of trial treatment.

The number of patients in each IMDC category are as follows:

• Overall Survival in the intention-to-treat population: Not Reached (HR=0.53, 95% CI, 038-0.74) p <0.0001)
• Progression Free Survival in the intention-to-treat population: Median progression-free survival was 15.1 months in the pembrolizumab–axitinib group and 11.1 months in the sunitinib group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.57 to 0.84; P<0.001).

1L = First Line
aRCC = Advanced Renal Cell Carcinoma
BICR - Blinded Independent Central Review
CI = Confidence Interval
CR = Complete Response
DOR = Duration Of Response
EMA = European Medicines Agency
HR = Hazard Ratio
IMDC = International Metastatic RCC Database Consortium
ORR = Objective Response Rate
OS = Overall Survival
PD-L1 = Programmed Death Ligand 1
PFS = Progression-Free Survival
PR = Partial Response
RECIST = Response Evaluation Criteria in Solid Tumors

Adverse events of any cause occurred in 98.4% of the 429 patients in the pembrolizumab–axitinib group who received the assigned treatment and in 99.5% of the 425 patients in the sunitinib group who received the assigned treatment.³

These events were of Grade 3 or higher in 75.8% of the patients in the pembrolizumab–axitinib group and in 70.6% of the patients in the sunitinib group;² 67.8% of the patients in the pembrolizumab–axitinib group and 63.8% of the patients in the sunitinib group had events of Grade 3 or higher that were attributed by the investigator to trial treatment.²

In the pembrolizumab–axitinib group, adverse events of any cause led to discontinuation of either or both drugs in 30.5% of patients, discontinuation of both drugs in 10.7%, interruption of either drug in 69.9%, and dose reduction of axitinib in 20.3%.³

The median time to discontinuation of both pembrolizumab and axitinib because of adverse events of any cause was 105.5 days, and the median time to discontinuation of pembrolizumab because of adverse events of any cause was 65 days.³

In the sunitinib group, adverse events of any cause led to discontinuation in 13.9% of patients, interruption in 49.9%, and dose reduction in 30.1%.³