Fruquintinib plus sintilimab in patients with advanced endometrial cancer with mismatch-repair proficient status: a multicenter, single-arm, phase Ib/II trial
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: This report presents the primary analysis of the endometrial cancer (EMC) cohort of FRUSICA-1 (ClinicalTrials.gov identifier, NCT03903705), a multicenter, single-arm, phase Ib/II study evaluating fruquintinib plus sintilimab. The cohort included Chinese patients with inoperable or advanced mismatch-repair proficient (pMMR) EMC who had progressed on or could not tolerate up to two prior platinum-based therapies, and comprised exploratory and pivotal phases. Patients received fruquintinib (5 mg orally once daily on a 2 weeks on/1 week off schedule) plus sintilimab (200 mg intravenously once every 3 weeks). The primary endpoint was objective response rate (ORR) assessed by an independent review committee (IRC). Secondary endpoints included ORR as assessed by the investigator, disease control rate, time to response, duration of response, progression-free survival (PFS) and tumor shrinkage as assessed by both the IRC and investigator, overall survival, and safety. By May 15, 2024, 98 patients with pMMR EMC were enrolled and treated. IRC-assessed ORR was 32.7% (95% confidence interval [CI] 23.5–42.9) for the total pMMR population (n = 98) and 31.6% (95% CI 21.4–43.3) for the pivotal population (n = 76). Median PFS was 8.6 months (95% CI 5.5–16.6) for the total population and 7.1 months (95% CI 5.4–16.6) for the pivotal population. The most common grade ≥3 treatment-related adverse event was hypertension (17.3%). In conclusion, fruquintinib plus sintilimab showed promising efficacy and tolerable safety in previously treated, advanced pMMR EMC. There is an unmet medical need for endometrial cancer patients with mismatch-repair proficient disease. Here, the authors report the primary analysis of the FRUSICA-1 phase Ib/II trial evaluating fruquintinib plus sintilimab in this population, showing an ORR of 32.7%, a median PFS of 8.6 months, and manageable toxicity.
Source: Nature Communications
Authors: Xiaohua Wu, Jing Wang, Danbo Wang, Guiling Li, Jieqing Zhang, Hongmin Chen, Hongying Yang, Qi Zhou, Ke Wang, Yumei Wu, Tienan Yi, Jihong Liu, Yi Huang, Yuxian Bai, Keming Wang, Kui Jiang, Hanmei Lou, Ruifang An, Xiumin Li, Yueyin Pan, Yue Wang, Weiping Tao, Kun Song, Yu Kang, Yuzhi Li, Wenyu Shi, Anwen Liu, Ying Yang, Yijun Wang, Keyan Chen, Haiyan Shi, Puhan Lu, Panfeng Tan, Songhua Fan, Michael Shi, Weiguo Su
Institutions: Fudan University Shanghai Cancer Center, Hunan Cancer Hospital, Liaoning Cancer Hospital & Institute, Wuhan Union Hospital, Huazhong University of Science and Technology, Guangxi Medical University, Tumor Hospital of Guangxi Medical University, Henan Cancer Hospital, Chongqing University, Chongqing Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital, Second Affiliated Hospital of Nanjing Medical University, Tianjin Medical University, Capital Medical University, Beijing Obstetrics and Gynecology Hospital, Xiangyang Central Hospital, Sun Yat-sen University Cancer Center, Hubei Cancer Hospital, Third Affiliated Hospital of Harbin Medical University, Second Affiliated Hospital of Dalian Medical University, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, First Affiliated Hospital of Xi'an Jiaotong University, Anhui Provincial Hospital, Jilin University, Henan Provincial People's Hospital, Renmin Hospital of Wuhan University, Qilu Hospital of Shandong University, Fudan University, Obstetrics and Gynecology Hospital of Fudan University, First Affiliated Hospital of Bengbu Medical College, Affiliated Hospital of Nantong University, Second Affiliated Hospital of Nanchang University, Yuhuangding Hospital, HUTCHMED (China) Limited (China)
Language: English
Subfield: Obstetrics and Gynecology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $6,990
Funder: Innovent Biologics
OpenAlex ID: W4417530870