
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:
IMDC prognostic risk - no. (%) | Pembrolizumab-axitinib | sunitinib |
---|---|---|
Favourable | 138 (31.9) | 131 (30.5) |
Intermediate | 238 (55.1) | 246 (57.3) |
Poor | 56 (13.0) | 52 (12.1) |