Lenvatinib Plus Pembrolizumab Demonstrates Durable Five-Year Survival Benefit in Patients with Advanced Endometrial Cancer

October 27,Eisai（Eisai）MSD and jointly announced that long-term follow-up data continued to show that forPatients with advanced endometrial cancer who have received at least one prior platinum-based regimen in any treatment setting`, developed by Eisai`Oral multi-receptor tyrosine kinase inhibitor (TKI) LenvatinibIn collaboration with MSDAnti-PD-1 Therapy PembrolizumabShows sustained benefit compared to chemotherapy. This finding, based on the five-year follow-up data from the Phase 3 309/KEYNOTE-775 trial evaluating lenvatinib in combination with pembrolizumab versus chemotherapy (doxorubicin or paclitaxel, chosen by the physician), was presented during the poster session at the 2025 European Society for Medical Oncology (ESMO) Congress held in Berlin, Germany.

In the pivotal Phase 3 309/KEYNOTE-775 trial,For patients with advanced endometrial cancer who are proficient in mismatch repair (pMMR), the five-year overall survival rate (OS) of lenvatinib combined with pembrolizumab was 16.7%, while that of chemotherapy alone was only 7.3%.

In the subgroup of patients with proficient mismatch repair (pMMR), the five-year overall survival (OS) results were consistent with the findings from the entire population: the overall survival rate was 19.9% in the lenvatinib plus pembrolizumab group, compared to 7.7% in the chemotherapy-alone group.

Based on the primary analysis results of the Study 309/KEYNOTE-775 trial published in March 2021, the combination of Lenvatinib and Pembrolizumab was approved for use in the United States.Patients with pMMR or non-high microsatellite instability (MSI-H) advanced endometrial cancer confirmed by FDA-approved testing, whose disease has progressed after receiving systemic therapy in any treatment setting, and who are not candidates for curative surgery or radiation therapy.. This combination therapy has been approved in the EU and Japan for certain patients with advanced or recurrent endometrial cancer, regardless of their mismatch repair status. Lenvatinib has been approved in the EU for the treatment of advanced renal cell carcinoma.

References:
[1] Advanced Endometrial Cancer: Lenvatinib + Pembrolizumab Shows Durable 5-Year Survival Benefit. From https://www.prnasia.com/story/508814-1.shtml

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