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February 21, 2026Journal for ImmunoTherapy of CancerOpen Access

Lenvatinib plus pembrolizumab in previously treated advanced endometrial cancer: 5-year outcomes from the randomized, phase 3 Study 309/KEYNOTE-775

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Authors

VMVicky MakkerNCNicoletta ColomboACAntonio Casado

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Overview

Phase 3 trial shows improved survival outcomes in advanced endometrial cancer using lenvatinib and pembrolizumab versus chemotherapy.

Key Points

  • This research aims to assess the long-term efficacy and safety of lenvatinib plus pembrolizumab in patients with advanced endometrial cancer after prior chemotherapy.
  • Randomized phase 3 trial (1:1) comparing lenvatinib plus pembrolizumab to chemotherapy (doxorubicin or paclitaxel).
  • Participants had advanced or recurrent endometrial cancer with disease progression after one prior platinum-based chemotherapy.
  • Primary endpoints included overall survival (OS) and progression-free survival (PFS), analyzed via Cox regression and Kaplan-Meier methods.
  • Five-year OS rate was 16.7% for lenvatinib plus pembrolizumab versus 7.3% for chemotherapy in mismatch repair-proficient EC.
  • Five-year PFS was 6.3% for lenvatinib plus pembrolizumab compared to 2.1% for chemotherapy in all-comers.
  • Treatment-related adverse events caused discontinuation in 32.3% of patients receiving lenvatinib plus pembrolizumab versus 5.9% in the chemotherapy group.

Cite This Study

Makker et al. (2026) studied this question.

synapsesocial.com/papers/69994c38873532290d02076chttps://doi.org/10.1136/jitc-2025-013713
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1#88 Lenvatinib plus pembrolizumab versus chemotherapy as first-line therapy for advanced or recurrent endometrial cancer: primary results of the phase 3 ENGOT-en9/LEAP-001 study2024 · 8 citations
  2. 2Lenvatinib Plus Pembrolizumab versus Doxorubicin for Advanced or Recurrent Endometrial Cancer with Short Treatment-Free Intervals Following First-Line Carboplatin Plus Paclitaxel2024 · 2 citations
  3. 3Lenvatinib Plus Pembrolizumab Versus Chemotherapy in Advanced Endometrial Cancer: Efficacy and Safety Insights2025
  4. 4Outcomes of reduced dosing of lenvatinib with pembrolizumab for advanced endometrial cancer.2024 · 1 citations
  5. 5158 Real world outcomes in patients with recurrent, advanced or metastatic endometrial cancer treated with lenvatinib plus pembrolizumab in England2024