Advanced Endometrial Cancer: Lenvatinib Plus Pembrolizumab

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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