pembrolizumab plus axitinib (n=432) vs. sunitinib (n=429)
randomized controlled trial
pembrolizumab plus axitinib
pembrolizumab was administred at a dose of 200 mg once every 3 weeks. Axitinib was administered orally at a dose of 5 mg twice daily, the dose could be increased to 7 mg,then 10 mg, twice daily if safety criteria were met and reduced to 3 mg, then 2 mg, twice daily to manage toxic effects
sunitinib
Sunitinib was administered orally at a dose of 50 mg daily for the first 4 weeks of each 6-week cycle the dose could be reduced to 37.5 mg, then 25 mg, for the first 4 weeks of each 6-week cycle to manage toxic effects.
metastatic/advanced RCC (mRCC) - 1st line (L1)
First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma
open-label
129 sites in 16 countries
P3 / one-sided test procedure with TWO interim analysis. Repartition between coprimary endpoints, and hierarchy with ORR
Among patients with previously untreated advanced renal-cell carcinoma, treatmentwith pembrolizumab plus axitinib resulted in significantly longer overall survival andprogression-free survival, as well as a higher objective response rate, than treatmentwith sunitinib.