Efficacy and Safety of Benmelstobart Plus Anlotinib in Advanced Endometrial Cancer: Results of a Multi-Cohort, Phase II Study (ETER200).
39 affiliations
- 1Department of Gynecologic Oncology Fudan University Shanghai Cancer Center Shanghai China.
- 2Department of Gynecology and Oncology Obstetrics & Gynecology Hospital of Fudan University Shanghai China.
- 3Department of Obstetrics and Gynecology Shanghai Tenth People's Hospital Shanghai China.
- 4Department of Gynecologic Oncology Tianjin Cancer Hospital Tianjin China.
- 5Gynecologic Oncology Center Chongqing University Cancer Hospital Chongqing China.
- 6Department of Obstetrics and Gynecology First Affiliated Hospital of Xi'an Jiaotong University Xi'an China.
- 7Department of Gynecology Yantai Yuhuangding Hospital Yantai China.
- 8Fifth Department of Obstetrics and Gynecology Liaoning Cancer Hospital & Institute Shenyang China.
- 9Department of Gynecology and Oncology Tianjin Central Hospital of Gynecology Obstetrics Tianjin China.
- 10Department of Gynecology and Oncology Sun Yat-Sen Memorial Hospital Sun Yat-Sen University Guangzhou China.
- 11Department of Gynecology and Oncology Beijing Obstetrics and Gynecology Hospital Capital Medical University Beijing China.
- 12Department of Gynecology Linyi Cancer Hospital Linyi China.
- 13Department of Medical Oncology Affiliated Hospital of Hebei University Baoding China.
- 14Department of Oncology Weifang People's Hospital Weifang China.
- 15Department of Gynecologic Oncology and Radiation Therapy Zhejiang Cancer Hospital Hangzhou China.
- 16Department of Gynecology and Oncology Guangxi Medical University Cancer Hospital Nanning China.
- 17Department of Obstetrics and Gynecology Beijing Chao-Yang Hospital Capital Medical University Beijing China.
- 18Department of Oncology Beijing Luhe Hospital Capital Medical University Beijing China.
- 19Department of Oncology Meizhou People's Hospital Meizhou China.
- 20Department of Oncology Affiliated Hospital of Jining Medical University Jining China.
- 21Department of Obstetrics and Gynecology The First Affiliated Hospital of USTC Anhui Provincial Hospital Hefei China.
- 22Department of Medical Oncology The First Affiliated Hospital of Shihezi University School of Medicine Shihezi China.
- 23Department of Gynecology Sun Yat-Sen University Cancer Center Guangzhou China.
- 24Fifth Department of Gynecologic Oncology Hunan Cancer Hospital Changsha China.
- 25Department of Obstetrics and Gynecology Second Hospital of Shanxi Medical University Taiyuan China.
- 26Department of Obstetrics and Gynecology The First Affiliated Hospital Sun Yat-Sen University Guangzhou China.
- 27Department of Oncology Binzhou Medical University Hospital Binzhou China.
- 28Department of Obstetrics and Gynecology Nanjing Drum Tower Hospital Nanjing China.
- 29Department of Gynecologic Oncology Qingdao Central Medical Group Qingdao China.
- 30Department of Obstetrics and Gynecology Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China.
- 31Department of Gynecology Gansu Provincial Maternity and Child-Care Hospital Lanzhou China.
- 32Department of Radiation Oncology Taizhou Hospital of Zhejiang Province Taizhou China.
- 33Department of Gynecology and Oncology Henan Cancer Hospital Zhengzhou China.
- 34Department of Oncology The Second Hospital of Anhui Medical University Hefei China.
- 35Department of Gynecology and Oncology Jiangsu Cancer Hospital Nanjing China.
- 36Department of Gynecology Affiliated Tumor Hospital of Xinjiang Medical University Urumqi China.
- 37Department of Obstetrics and Gynecology Xi'an People Hospital (Xi'an Fourth Hospital) Xi'an China.
- 38Department of Gynecology Qilu Hospital of Shandong University Jinan China.
- 39Department of Obstetrics and Gynecology Beijing Tsinghua Changgung Hospital Beijing China.
Abstract
Patients with advanced endometrial cancer (EC) have a poor prognosis and limited therapeutic options after failure of prior systemic therapy. In this multi-cohort Phase II study (ETER200), patients with metastatic or recurrent EC who had received at least one chemotherapy regimen were enrolled. Based on MSI/MMR status, patients received benmelstobart plus anlotinib (Cohort 1), benmelstobart (Cohort 2), or anlotinib (Cohort 3) every 3 weeks. Primary endpoint was objective response rate (ORR) assessed by independent review committee (IRC) per RECIST v1.1. Here, the results of Cohort 1 expansion stage were reported. As of May 9, 2024, 85 of the 107 non-MSI-H/pMMR EC patients enrolled in Cohort 1 constituted the expansion stage population for primary efficacy analysis. The IRC-assessed ORR was 34.1% (95% CI, 24.2-45.2), with a median duration of response of 15.2 months (95% CI, 6.9-not evaluable). Median progression-free and overall survival were 8.8 months (95% CI, 5.8-15.2) and 21.8 months (95% CI, 19.5-29.1), respectively. Grade ≥ 3 treatment-related adverse events occurred in 69.2% of patients, most commonly hypertension (21.2%) and palmar-plantar erythrodysesthesia syndrome (9.4%). Overall, benmelstobart plus anlotinib showed promising anti-tumor activity and an acceptable safety profile in advanced non-MSI-H/pMMR EC, supporting further evaluation of this combination in randomized Phase III studies. Trial Registration: ClinicalTrials.gov, NCT04574284.
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BibTeX
@article{liang2026efficacy,
title = {{Efficacy and Safety of Benmelstobart Plus Anlotinib in Advanced Endometrial Cancer: Results of a Multi-Cohort, Phase II Study (ETER200).}},
author = {Shanhui Liang and Xiaojun Chen and Ke Wang and Dong Wang and Ruifang An and Jianqing Hou and Ying Yang and Danbo Wang and Pengpeng Qu and Bingzhong Zhang and Wei Duan and Xiumin Li and Aimin Zang and Guohua Yu and Hanmei Lou and Desheng Yao and Shuzhen Wang and Dong Yan and Liang Li and Xiaowei Liu and Weidong Zhao and Zhengzheng Chen and Jing Fei and Jundong Li and Jing Wang and Zhilian Wang and Shuzhong Yao and Fangling Ning and Huaijun Zhou and Li Sun and Lingya Pan and Qing Liu and Haihua Yang and Li Wang and Mingjun Zhang and Xiaoxiang Chen and Jianlin Yuan and Xinwen Zhang and Youzhong Zhang and Qinping Liao and Xiaohua Wu},
journal = {MedComm},
year = {2026},
month = oct,
doi = {10.1002/mco2.71081},
url = {https://europepmc.org/article/MED/42910366},
note = {CC BY},
}
RIS
TY - JOUR
TI - Efficacy and Safety of Benmelstobart Plus Anlotinib in Advanced Endometrial Cancer: Results of a Multi-Cohort, Phase II Study (ETER200).
AU - Shanhui Liang
AU - Xiaojun Chen
AU - Ke Wang
AU - Dong Wang
AU - Ruifang An
AU - Jianqing Hou
AU - Ying Yang
AU - Danbo Wang
AU - Pengpeng Qu
AU - Bingzhong Zhang
AU - Wei Duan
AU - Xiumin Li
AU - Aimin Zang
AU - Guohua Yu
AU - Hanmei Lou
AU - Desheng Yao
AU - Shuzhen Wang
AU - Dong Yan
AU - Liang Li
AU - Xiaowei Liu
AU - Weidong Zhao
AU - Zhengzheng Chen
AU - Jing Fei
AU - Jundong Li
AU - Jing Wang
AU - Zhilian Wang
AU - Shuzhong Yao
AU - Fangling Ning
AU - Huaijun Zhou
AU - Li Sun
AU - Lingya Pan
AU - Qing Liu
AU - Haihua Yang
AU - Li Wang
AU - Mingjun Zhang
AU - Xiaoxiang Chen
AU - Jianlin Yuan
AU - Xinwen Zhang
AU - Youzhong Zhang
AU - Qinping Liao
AU - Xiaohua Wu
PY - 2026
DA - 2026/10/21
JO - MedComm
DO - 10.1002/mco2.71081
UR - https://europepmc.org/article/MED/42910366
AB - Patients with advanced endometrial cancer (EC) have a poor prognosis and limited therapeutic options after failure of prior systemic therapy. In this multi-cohort Phase II study (ETER200), patients with metastatic or recurrent EC who had received at least one chemotherapy regimen were enrolled. Based on MSI/MMR status, patients received benmelstobart plus anlotinib (Cohort 1), benmelstobart (Cohort 2), or anlotinib (Cohort 3) every 3 weeks. Primary endpoint was objective response rate (ORR) assessed by independent review committee (IRC) per RECIST v1.1. Here, the results of Cohort 1 expansion stage were reported. As of May 9, 2024, 85 of the 107 non-MSI-H/pMMR EC patients enrolled in Cohort 1 constituted the expansion stage population for primary efficacy analysis. The IRC-assessed ORR was 34.1% (95% CI, 24.2-45.2), with a median duration of response of 15.2 months (95% CI, 6.9-not evaluable). Median progression-free and overall survival were 8.8 months (95% CI, 5.8-15.2) and 21.8 months (95% CI, 19.5-29.1), respectively. Grade ≥ 3 treatment-related adverse events occurred in 69.2% of patients, most commonly hypertension (21.2%) and palmar-plantar erythrodysesthesia syndrome (9.4%). Overall, benmelstobart plus anlotinib showed promising anti-tumor activity and an acceptable safety profile in advanced non-MSI-H/pMMR EC, supporting further evaluation of this combination in randomized Phase III studies. Trial Registration: ClinicalTrials.gov, NCT04574284.
SN - 2688-2663
ER -