Advanced Endometrial Cancer: Lenvatinib Plus Pembrolizumab
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KEYNOTE-775 Phase III Trial Results
- April 19, 2023
On April 14, 2023, researchers from Memorial Sloan Kettering Cancer Center led by Vicky Makker published KEYNOTE-775/Study 309 Phase III trial results in the Journal of Clinical Oncology, evaluating lenvatinib plus pembrolizumab versus chemotherapy in previously treated advanced endometrial cancer.
Trial Design
Patient Population: Previously treated advanced endometrial cancer
Treatment Arms (1:1 randomization):
- Lenvatinib 20 mg daily plus Pembrolizumab 200 mg on Day 1 of each 3-week cycle (n=411)
- Chemotherapy standard regimen (n=416)
Primary Endpoints: Progression-free survival, overall survival
Key Efficacy Results
Overall Survival (pMMR patients):
- 30% mortality reduction with lenvatinib + pembrolizumab vs chemotherapy
Progression-Free Survival:
- pMMR patients: 40% risk reduction
- ITT population: 44% risk reduction
Objective Response Rate:
- Lenvatinib + pembrolizumab: 33.8%
- Chemotherapy: 14.7%
Safety Profile
Adverse events reported in 99.8% of lenvatinib + pembrolizumab group and 99.5% of chemotherapy group. No novel toxicities identified; adverse event profile consistent with established safety data.
Clinical Conclusions
Lenvatinib plus pembrolizumab demonstrates superior efficacy versus chemotherapy in previously treated advanced endometrial cancer with well-controlled and manageable toxicity.
Data Source
https://ascopubs.org/doi/full/10.1200/JCO.22.02152
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