Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Feb;30(2):371-379.
doi: 10.1007/s10147-024-02667-0. Epub 2024 Dec 6.

The efficacy and safety of lenvatinib plus pembrolizumab in vulnerable patients with metastatic or recurrent endometrial cancer: a single institution experience

Mayu Yunokawa  1   2 , Akiko Abe  3 , Xiaofei Wang  4 , Yusuke Toyohara  3 , Ryo Nimura  3 , Takayuki Komoto  3 , Satoki Misaka  3 , Teruyuki Yoshimitsu  3 , Ai Ikki  3 , Mayumi Kamata  3 , Shogo Nishino  3 , Motoko Kanno  3 , Atsushi Fusegi  3 , Sachiho Netsu  3 , Yoichi Aoki  3 , Makiko Omi  3 , Terumi Tanigawa  3 , Sanshiro Okamoto  3 , Hidetaka Nomura  3 , Hiroyuki Kanao  3
Affiliations

The efficacy and safety of lenvatinib plus pembrolizumab in vulnerable patients with metastatic or recurrent endometrial cancer: a single institution experience

Mayu Yunokawa et al. Int J Clin Oncol. 2025 Feb.

Abstract

Background: Effective management with second-line therapy with the lenvatinib + pembrolizumab regimen for patients with advanced endometrial cancer is necessary.

Methods: This retrospective study enrolled patients with endometrial cancer treated with the lenvatinib + pembrolizumab regimen. We evaluated progression-free survival (PFS), overall survival (OS), safety for patients non-eligible for the KEYNOTE775 trial, aged ≥65 years, or with ECOG performance status 1-2.

Results: Forty-five patients were analyzed: 21 (47%) were aged ˃ 65 years, 16 (36%) had performance status 1-2, and 15 (33%) were non-eligible for KEYNOTE775 trial participation. Overall, the median PFS was 8.5 months (95% confidence interval [CI] 4.6-12.4), and the median OS was 15.6 months (95% CI 9.4-NA). Median PFS was significantly shorter in patients not eligible for KEYNOTE775 participation and with performance status 1-2. The median OS was significantly shorter in patients with performance status 1-2. Grade ˃3 adverse events (AEs) occurred in 78% of patients who received the lenvatinib + pembrolizumab regimen. AEs resulted in lenvatinib dose reductions in 35 patients (78%) and lenvatinib and pembrolizumab discontinuation in 3 (7%) and 5 (11%), respectively. The median time to the first lenvatinib dose reduction was 1.5 (0.92-2.3) months in all patients and was significantly shorter in patients aged >65 years.

Conclusions: The current regimen has favorable efficacy and manageable safety with appropriate dose reduction of lenvatinib in the real world. However, the efficacy may be inferior in patients with performance status 1 or 2, heavily treated patients, and those with organ dysfunction. The current treatment status should reflect real-world data relative to the medical environment and management.

Keywords: KEYNOTE775; Lenvatinib; Metastatic endometrial cancer; Pembrolizumab; Real-world; Recurrent endometrial cancer.

PubMed Disclaimer

Conflict of interest statement

Declarations. Conflict of interest: The authors declare no conflicts of interest.

References

    1. Saito T, Takahashi F, Katabuchi H (2017) 2016 committee on gynecologic oncology of the Japan Society of Obstetrics and Gynecology, annual report of the committee on gynecologic oncology, Japan Society of Obstetrics and Gynecology: patient annual report for 2014 and treatment annual report for 2009. J Obstet Gynaecol Res 43:1667–1677 - DOI - PubMed
    1. Miller DS, Filiaci VL, Mannel RS et al (2020) Carboplatin and paclitaxel for advanced endometrial cancer: final overall survival and adverse event analysis of a phase III trial (NRG Oncology/GOG0209). J Clin Oncol 38:3841–3850 - DOI - PubMed - PMC
    1. Makker V, Colombo N, Herráez AC et al (2022) Lenvatinib plus pembrolizumab for advanced endometrial cancer. N Engl J Med 386:437–448 - DOI - PubMed - PMC
    1. Yonemori K, Yunokawa M, Ushijima K et al (2022) Lenvatinib plus pembrolizumab in Japanese patients with endometrial cancer: results from Study 309/KEYNOTE-775. Cancer Sci 113:3489–3497 - DOI - PubMed - PMC
    1. Booth CM, Tannock IF (2014) Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence. Br J Cancer 110:551–555 - DOI - PubMed - PMC

MeSH terms

LinkOut - more resources