lenvatinib in association (n=411) vs. Standard of Care (SoC) (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
Randomization to treatment group was initially stratified according to MMR status (deficient [dMMR] or proficient [pMMR]). Furthermore, within the pMMR population, patients were stratified according to ECOG performance-status score (0 or 1), geographic region (region 1 [Australia, Canada, Europe, Israel, New Zealand, and the United States] or region 2 [rest of the world]), and history of pelvic irradiation (yes or no)
open design
167 sites in 21 countries
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,
LEAP-001/ENGOT-en9, 2024 NCT03884101
lenvatinib in association (n=-9) vs. Standard of Care (SoC) (n=-9)
randomized controlled trial
pembrolizumab plus levitinib
lenvatinib 20 mg daily and pembrolizumab 200 mg once at the start of each 3-week treatment cycle.Pembrolizumab must be stopped after 35 cycles, butlenvatinib may continue after stopping pembrolizumab
carboplatine plus paclitaxel
paclitaxel 175mg/m² and carboplatin once at the start of each 3-week treatment cycle. . Patients couldhave received up to seven cycles of paclitaxel/carboplatin; however, chemotherapy treatment beyond seven cycles was permitted for patients who continued to derive clinical benefit
endometrial cancer
open design
190 community clinics and academic hospitals in 22 countries
press release from 2024 SGO annual muuting on women's cancer