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Updated: Jun 6, 2025

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First-Line Lenvatinib Plus Pembrolizumab Versus Chemotherapy for Advanced Endometrial Cancer: A Randomized,

Christian Marth1, Richard G Moore2, Mariusz Bidziński3

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|November 26, 2024
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First-line lenvatinib plus pembrolizumab did not demonstrate statistically significant improvements in progression-free survival or overall survival compared to chemotherapy for advanced or recurrent endometrial cancer in the pMMR population.

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Area of Science:

  • Oncology
  • Clinical Trials
  • Gynaecological Oncology

Background:

  • Advanced or recurrent endometrial cancer (aEC) presents a significant treatment challenge.
  • Previous studies (Study 309/KEYNOTE-775) showed efficacy of lenvatinib plus pembrolizumab in previously treated aEC.
  • The LEAP-001 study evaluated this combination in the first-line setting.

Purpose of the Study:

  • To evaluate the efficacy of first-line lenvatinib plus pembrolizumab versus chemotherapy in patients with advanced or recurrent endometrial cancer.
  • To assess progression-free survival (PFS) and overall survival (OS) as primary endpoints.
  • To analyze outcomes in both mismatch repair-proficient (pMMR) and all-comers populations.

Main Methods:

  • Phase III, randomized, open-label European trial (LEAP-001, NCT03884101).
  • Patients received lenvatinib (20 mg daily) plus pembrolizumab (200 mg every 3 weeks) or paclitaxel plus carboplatin.
  • Primary endpoints: PFS and OS. Noninferiority for OS was assessed in the pMMR population.

Main Results:

  • Median PFS in pMMR population: 9.6 months (len + pembro) vs 10.2 months (chemotherapy).
  • Median OS in pMMR population: 30.9 months (len + pembro) vs 29.4 months (chemotherapy); HR 1.02, P=0.246 (not statistically significant).
  • Higher rates of Grade ≥3 treatment-related adverse events with len + pembro (79%) vs chemotherapy (67%).

Conclusions:

  • First-line lenvatinib plus pembrolizumab did not meet prespecified statistical criteria for PFS or OS versus chemotherapy in the pMMR aEC population.
  • The combination showed numerically similar OS in all-comers but did not achieve statistical significance.
  • Further evaluation of this regimen in the first-line setting for aEC is warranted based on these findings.