Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025
First-Line Lenvatinib Plus Pembrolizumab Versus Chemotherapy for Advanced Endometrial Cancer: A Randomized, Open-Label, Phase III Trial.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03884101 (A Phase 3 Randomized, Open-Label, Study of Pembrolizumab), which is not on this map. Cited by 34 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)
Who cites it
34 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- SEOM-GEICO clinical guidelines on endometrial cancer (2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Guideline
- The Efficacy of Pembrolizumab Immunotherapy in the Treatment of Endometrial Cancer: A Systematic Review.International journal of molecular sciences · 2025Pooled it
- Practice guideline for management of endometrial cancer in Thailand: a Thai Gynecologic Cancer Society consensus statement.Journal of gynecologic oncology · 2025Guideline
- Lenvatinib plus pembrolizumab in previously treated advanced endometrial cancer: 5-year outcomes from the randomized, phase 3 Study 309/KEYNOTE-775.Journal for immunotherapy of cancer · 2026Trial
- IMMU-NO versus yes: Applicability of immune checkpoint inhibitors in gynecologic cancers.Cancer · 2026Review
- Immunotherapy in Gynecologic Cancers: Current Evidence, Biomarker-Driven Practice, and Future Directions.Cancers · 2026Review
- Clinical applications of biomarker guidance extend beyond treatment to diagnosis.Journal of the Chinese Medical Association : JCMA · 2026Article
- Redefining the Treatment Landscape of Advanced Endometrial Cancer in the Era of Immunotherapy and Precision Oncology.Cancers · 2026Review
- Real World Outcomes of Pembrolizumab and Reduced-Dose Lenvatinib in Recurrent Endometrial Cancer by Platinum and p53 Status.Gynecologic oncology reports · 2026Article
- Review
- Endometrial cancer therapy in 2026.Current opinion in obstetrics & gynecology · 2026Review
- Stem cell engineering for the generation of allogeneic CAR-directed natural killer T cells targeting endometrial carcinoma.Experimental hematology & oncology · 2026Article
- Review
- Advancements in the utilization of immune checkpoint inhibitors for the treatment of gynecological tumors.Frontiers in immunology · 2026Review
- Predictive biomarkers for immunotherapy response in endometrial cancer: current insights and future directions.Exploration of targeted anti-tumor therapy · 2026Review
- Natural killer cells at the interface of tumor immune escape and immunotherapy resistance in endometrial cancer.Frontiers in immunology · 2026Review
- Review
- Immune checkpoint inhibitors or targeted therapy by mismatch repair status in endometrial cancer: a meta-analysis.Future science OA · 2025Review
- A challenge for treating patients with extensive-stage small cell lung cancers, particularly for those with liver metastases.Journal of the Chinese Medical Association : JCMA · 2025Article
- Prognostic factors of lenvatinib plus pembrolizumab therapy for advanced or recurrent endometrial cancer: analysis of a multicenter cohort study in Japan.International journal of clinical oncology · 2025Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
31 authors.
Funding
Abstract
purposeLenvatinib plus pembrolizumab (len + pembro) significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in previously treated advanced or recurrent endometrial cancer (aEC) in the phase III Study 309/KEYNOTE-775. We report results from the phase III, randomized, open-label European Network of Gynaecological Oncological Trial-en9/LEAP-001 study (ClinicalTrials.gov identifier: NCT03884101) that evaluated len + pembro versus chemotherapy in first-line aEC.
methodsPatients with stage III to IV or recurrent, radiographically apparent EC and no previous chemotherapy or disease progression ≥6 months after neo/adjuvant platinum-based chemotherapy were randomly assigned 1:1 to lenvatinib 20 mg once daily plus pembrolizumab 200 mg once every 3 weeks or paclitaxel 175 mg/m
resultsEight hundred forty-two patients were randomly assigned (len + pembro, n = 420 [pMMR population, n = 320]; chemotherapy, n = 422 [pMMR population, n = 322]). At FA (data cutoff, October 2, 2023), median PFS (95% CI) in the pMMR population was 9.6 (8.2 to 11.9) versus 10.2 (8.4 to 10.5) months with len + pembro versus chemotherapy (hazard ratio [HR], 0.99 [95% CI, 0.82 to 1.21]) and among all-comers was 12.5 (10.3 to 15.1) versus 10.2 (8.4 to 10.4) months (HR, 0.91 [95% CI, 0.76 to 1.09]; descriptive analyses). Median OS (95% CI) in the pMMR population was 30.9 (25.4 to 37.7) versus 29.4 (26.2 to 35.4) months with len + pembro versus chemotherapy (HR, 1.02 [95% CI, 0.83 to 1.26]; noninferiority
conclusionFirst-line len + pembro did not meet prespecified statistical criteria for PFS or OS versus chemotherapy in pMMR aEC.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.