Efficacy and safety of cadonilimab combined with chemotherapy as first-line treatment for primary advanced or recurrent endometrial cancer: An interim analysis of a prospective, single-arm, open-label phase II trial

IF 4.1 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Gynecologic oncology Pub Date : 2026-04-01 Epub Date: 2026-04-17 DOI:10.1016/j.ygyno.2026.03.014

Bin Liu , Jian Chen , Lijun Chen , Xiaoxiang Chen , Yanhong Zhuo , Linlin Yang , Yuzhi Li , Jie Lin , Xinye Guo , Yingtao Lin , Tongyu Liu , Jianping Zou , Yu Jiang , Yang Sun

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Abstract

Objective

To assess the interim efficacy and safety of cadonilimab, a PD-1/CTLA-4 bispecific antibody, in combination with platinum-based chemotherapy as first-line treatment for patients with primary advanced or recurrent endometrial cancer (EC), with exploratory analyses by molecular subgroups.

Methods

This investigator-initiated, multicenter, open-label, single-arm phase II trial enrolled women aged 18–75 years with histologically confirmed FIGO stage III/IV or recurrent EC. Patients received cadonilimab (10 mg/kg intravenously every 3 weeks) combined with platinum-based chemotherapy, followed by cadonilimab maintenance. The primary endpoint was objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. Exploratory analyses were performed according to PD-L1 expression, mismatch repair (MMR) status, and molecular subtype. This interim analysis was conducted after 27 efficacy-evaluable patients reached the predefined PFS milestone.

Results

Among 27 patients, ORR was 74.1% (95% CI, 55.6%–87.3%), including one complete response (3.7%) and 19 partial responses (70.4%), with a DCR of 96.3%. Median time to response was 2.8 months, and median DoR was 17.8 months (95% CI, 8.8–not estimable). Median PFS was 10.5 months (95% CI, 8.2–not estimable), with a 12-month PFS rate of 49.6%. Median OS was not reached; the 12-month OS rate was 90.2%. ORR was generally consistent across subgroups, while patients with dMMR tumors showed a lower risk of disease progression compared with those with pMMR tumors. Treatment-related adverse events occurred in 77.8% of patients, predominantly grade 1–2; grade ≥ 3 events occurred in 18.5%, with no treatment-related deaths.

Conclusions

Cadonilimab combined with chemotherapy demonstrated clinically meaningful activity and manageable safety as first-line treatment for advanced or recurrent EC, supporting further investigation, particularly in molecularly defined populations.

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卡多尼莫单抗联合化疗作为原发性晚期或复发性子宫内膜癌一线治疗的疗效和安全性：一项前瞻性、单臂、开放标签II期试验的中期分析

目的评价PD-1/CTLA-4双特异性抗体卡多尼利单抗联合铂类化疗一线治疗原发性晚期或复发性子宫内膜癌（EC）的中期疗效和安全性，并进行分子亚组探索性分析。该研究由研究者发起，多中心，开放标签，单臂II期试验，招募年龄为18-75岁，组织学证实为FIGO III/IV期或复发性EC的女性。患者接受卡多尼单抗（10mg /kg静脉滴注，每3周一次）联合铂类化疗，随后进行卡多尼单抗维持。主要终点是根据RECIST v1.1评估的客观缓解率（ORR）。次要终点包括疾病控制率（DCR）、反应持续时间（DoR）、无进展生存期（PFS）、总生存期（OS）和安全性。根据PD-L1表达、错配修复（MMR）状态和分子亚型进行探索性分析。这项中期分析是在27名可评估疗效的患者达到预定的PFS里程碑后进行的。结果27例患者的ORR为74.1% (95% CI, 55.6% ~ 87.3%)，其中完全缓解1例（3.7%），部分缓解19例（70.4%），DCR为96.3%。中位缓解时间为2.8个月，中位DoR为17.8个月（95% CI， 8.8 -不可估计）。中位PFS为10.5个月（95% CI, 8.2，无法估计），12个月PFS率为49.6%。中位OS未达到；12个月OS率为90.2%。ORR在各个亚组中基本一致，而dMMR肿瘤患者的疾病进展风险低于pMMR肿瘤患者。77.8%的患者发生治疗相关不良事件，主要为1-2级；18.5%发生≥3级事件，无治疗相关死亡。结论：scadonilimab联合化疗作为晚期或复发性EC的一线治疗具有临床意义的活性和可管理的安全性，支持进一步的研究，特别是在分子定义人群中。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Gynecologic oncology 医学-妇产科学

CiteScore

8.60

自引率

6.40%

发文量

1062

审稿时长

37 days

期刊介绍： Gynecologic Oncology, an international journal, is devoted to the publication of clinical and investigative articles that concern tumors of the female reproductive tract. Investigations relating to the etiology, diagnosis, and treatment of female cancers, as well as research from any of the disciplines related to this field of interest, are published. Research Areas Include: • Cell and molecular biology • Chemotherapy • Cytology • Endocrinology • Epidemiology • Genetics • Gynecologic surgery • Immunology • Pathology • Radiotherapy