lenvatinib in association (n=411) vs. doxorubicin (n=416)
randomized controlled trial
pembrolizumab plus lenvatinib
oral lenvatinib at 20 mg daily and pembrolizumab at 200 mg intravenously (IV) every 3 weeks
Paclitaxel or Doxorubicin
doxorubicin at 60 mg/m2 IV every 3 weeks or paclitaxel at 80 mg/m2 IV weekly on a 3-weeks-on/1-week-off schedule
endometrial cancer
open design
P3 / 1-sided at 0.025 / PFS at 0.0005 and OS at 0.0245
Lenvatinib plus pembrolizumab showed statistically significant and clinically meaningful improvements in overall survival, progression-free survival [PFS], and objective response rate [ORR] versus treatment of physician’s choice, regardless of MMR status in endometrial cancer following prior platinum-based chemotherapy,