The approval is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated significant improvements in overall survival, progression-free survival and objective response rate for Keytruda in combination with axitinib (Keytruda-axitinib combination) compared to sunitinib.
Consistent results were observed across pre-specified subgroups, IMDC risk categories and PD-L1 tumor expression status.
For the main efficacy outcome measures of OS and PFS, the Keytruda-axitinib combination reduced the risk of death by 47% compared to sunitinib (HR=0.53 [95% CI, 0.38-0.74]; p
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