Evidence map›Paper›PMID 42830785›Full record

ArticleEClinicalMedicine2026

E7386 plus lenvatinib in patients with advanced endometrial cancer that progressed on platinum-based chemotherapy and an anti-PD-(L)1 immunotherapy: a single-arm, open-label, global phase 1b/2 dose-expansion cohort.

Jung-Yun Lee, Kosei Hasegawa, Byoung-Gie Kim, Barry Berman, Shiro Suzuki, Bradley Corr, Mayu Yunokawa, Douglas Orr, Noboru Yamamoto, Pamela T Soliman and 8 more

Registry-linked trialAbstract read
In one paragraph

Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04008797 (An Open-label Study of E7386 in Combination With Other Anticancer Drug), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT04008797 phase1 / phase2active not recruitingnot on this map

An Open-label Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors

TypeinterventionalSponsorEisai Inc.Ran2019 to 2027Enrolled301ConditionsEndometrial Neoplasms, Neoplasms, Carcinoma, Hepatocellular, Liver NeoplasmsArmsE7386, Lenvatinib, Doxorubicin, Paclitaxel
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Jung-Yun LeeDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Korea.
Kosei HasegawaDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Byoung-Gie KimDepartment of Obstetrics and Gynecology, Chung-Ang University Gwangmyeong Hospital, Gyeonggi-do, Korea.
Barry BermanFlorida Cancer Specialists, West Palm Beach, FL, USA.
Shiro SuzukiDepartment of Gynecologic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Bradley CorrDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado Denver, Anschutz Medical Campus, Aurora, CO, USA.
Mayu YunokawaDepartment of Gynecology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
Douglas OrrSarah Cannon Research Institute at Mary Crowley, Dallas, TX, USA.
Noboru YamamotoDepartment of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.
Pamela T SolimanDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
David S MillerGynecologic Oncology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Alka A PotdarClinical Evidence Generation, Eisai Inc., Nutley, NJ, USA.
Takatoshi SaharaJapan and Asia Clinical Development, Oncology Business Group, Eisai Co., Ltd, Tokyo, Japan.
Takayuki KimuraTsukuba Research Laboratories, Eisai Co., Ltd, Tsukuba, Ibaraki, Japan.
Lea DuttaClinical Development, Eisai Inc., Nutley, NJ, USA.
Jincao WuClinical Development, Eisai Inc., Nutley, NJ, USA.
Jodi McKenzieClinical Development, Eisai Inc., Nutley, NJ, USA.
Chrisann KyiMedical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Novel therapies are needed for advanced endometrial cancer (aEC) that recurs after chemotherapy + immunotherapy. Lenvatinib has antitumour activity in patients with aEC after platinum-based chemotherapy and is approved in combination with pembrolizumab for aEC following prior systemic therapy. E7386, an oral anticancer agent, inhibits the interaction between β-catenin and CREB-binding protein (CBP). Preliminary results of a dose expansion cohort of Study 102 (n = 16) showed manageable safety and promising antitumour activity of E7386 + lenvatinib in aEC that progressed after platinum-based chemotherapy and anti-programmed cell death (ligand) 1, including responses in patients with prior lenvatinib. We report safety and antitumour activity for this complete dose expansion cohort. Methods: In a dose expansion cohort of Study 102 (NCT04008797), patients with aEC that progressed after platinum-based chemotherapy and immunotherapy received E7386 120 mg twice daily plus lenvatinib 14 mg once daily (amended from 20 mg during enrolment). The primary endpoint was safety; secondary endpoints included objective response rate (ORR), duration of response, clinical benefit rate, and progression-free survival by investigator per RECIST v1·1). Findings: Thirty patients were enrolled; 16 (53·3%) previously received lenvatinib. By data cut-off (4 June, 2025), five (16·7%) patients had treatment ongoing. All patients experienced treatment-emergent adverse events (TEAEs), most commonly vomiting (n = 22, 73·3%). Nineteen (63·3%) patients had grade 3 TEAEs, most frequently diarrhoea (n = 4). No grade 4-5 AEs were observed. TEAEs led to withdrawal of lenvatinib and/or E7386 in two patients. Overall, 11 patients (three with prior lenvatinib) had a confirmed response (one complete, ten partial) for an ORR of 36·7% (95% CI: 19·9-56·1). In patients without prior lenvatinib (n = 14), the ORR was 57·1% (95% CI: 28·9-82·3). Interpretation: E7386 + lenvatinib showed promising antitumour activity with a manageable safety profile in heavily pretreated patients with aEC following platinum-based chemotherapy + immunotherapy. The dose-optimisation phase of Study 102 (E7386 + lenvatinib in patients with advanced endometrial carcinoma) is currently enrolling (NCT04008797). Funding: Eisai Inc., Nutley, NJ, USA.

Indexed as

Dose expansionE7386 plus lenvatinibEndometrial cancerPost-immunotherapy

Identifiers

PMID42830785
PMCPMC13634084

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