The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which Keytruda plus Lenvima demonstrated statistically significant improvements in overall survival, reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84]; p=0.0001), and progression-free survival, reducing the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.50-0.72]; p
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