Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status.

• DOI: 10.1200/jco.2025.43.16_suppl.5596
• Publication Date: 2025-05-28T15:30:47Z
• 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; Weiguo Su

5596 Background: Serous carcinoma represents approximately 10% of all EMC, has the highest recurrence rate and is responsible for a disproportionate 40% mortality in EMC. Additionally, overall 5-year survival only 33% stage III-IV serous carcinoma. Fruquintinib (F, highly selective VEGFR inhibitor) plus sintilimab (S, an anti-PD-1 monoclonal antibody) was evaluated open-label, single-arm phase 2 pivotal study (FRUSICA-1, NCT03903705), demonstrated encouraging efficacy favorable safety profile treated advanced EMC pts with pMMR (proficient mismatch repair) status (Wu X, et al; 2024 ASCO). Here, we report ad hoc updated analysis results subgroup (data cutoff: May 15, 2024). Methods: Eligible had histologically confirmed, previously confirmed by central lab. They received F (5 mg QD, weeks on/1 week off, orally) S (200 mg, IV, Q3W) 21-day cycles until disease progression or unacceptable toxicity. Ad analyses were conducted to evaluate primary endpoint (ORR) secondary endpoints (DCR, DoR, TTR, PFS, OS, safety) F+S endometrial Results: As data cutoff date (May 2024), 98 enrolled combination treatment (ITT population), among them, 27 In these pts, median age 63.1 years, 22 (81.5%) Ⅳ disease, 7 (25.9%) prior bevacizumab therapy, 5 (18.5%) pelvic radiotherapy. IRC-assessed ORR 37.0% (95%CI: 19.4%, 57.6%), DCR 88.9% 70.8%, 97.7%). Median DoR TTR 17.9 3.3, not estimable [NE]) months, 2.4 1.2, 4.0) respectively. With PFS OS follow-up 8.3 21.7 8.8 6.9, 19.2) months 19.0 11.4, NE) These findings similar those observed ITT population. Grade ≥3 related adverse events (TRAE) occurred 63.0% most common ≥Grade 3 TRAEs included palmar-plantar erythrodysesthesia syndrome (22.2%) hypertension (11.1%). Conclusions: tolerable showed clinically meaningful carcinoma, characterized durable responses that comparable across Clinical trial information: NCT03903705 .