PO.CT01.05 · 临床试验

卡度尼利单抗（一种PD-1/CTLA-4双特异性抗体）联合化疗（chemo）作为晚期胰腺导管腺癌（PDAC）一线治疗的一项II期、多中心、开放标签研究（COMPASSION-26）

A phase II, multicenter, open-label study (COMPASSION-26) of cadonilimab, a PD-1/CTLA-4 bispecific antibody,combined with chemotherapy (chemo) as first-line therapy for advanced pancreatic ductal adenocarcinoma (PDAC)

编号 CT145 展板 9 时间 4/20 02:00–05:00 区域 Section 52 主讲 Zhongmin Maxwell Wang

分会场 Phase II and Phase III Clinical Trials

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作者与单位 Authors & Affiliations

Wenming Wu¹, Xiafei Hong¹, Qi Xu², Gang Jin³, Zhihua Li⁴, He Tian⁵, Heshui Wu⁶, Yiping Mou⁷, Baocai Xing⁸, Dianrong Xiu⁹, Zhifang Yao¹⁰, Zhongmin Maxwell Wang¹⁰, Baiyong Li¹⁰, Yu Xia¹⁰

¹Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China,²Zhejiang Cancer Hospital, Hangzhou, China,³Changhai Hospital, Shanghai, China,⁴Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China,⁵Shandong Cancer Hospital and Institute, Jinan, China,⁶Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China,⁷Zhejiang Provincial People's Hospital, Hangzhou, China,⁸Beijing Cancer Hospital, Beijing, China,⁹Peking University Third Hospital, Beijing, China,¹⁰AkesoBiopharma,Inc., Zhongshan, China

摘要 Abstract

中文摘要

背景：PDAC是一种高度致命的恶性肿瘤，约80%的患者在诊断时即表现为无法切除的局部晚期或转移性疾病。晚期PDAC预后仍然较差，治疗选择有限。卡度尼利单抗是一种PD-1/CTLA-4双特异性抗体，在胃癌和宫颈癌的3期试验中已显示出令人信服的疗效和良好的安全性特征。在此，我们报告在一项2期研究（NCT05859750）中，卡度尼利单抗联合AG（吉西他滨联合白蛋白结合型紫杉醇）作为晚期PDAC患者（pts）一线治疗的初步疗效和安全性结果。方法：入组无法切除的晚期或转移性PDAC且既往未接受过系统治疗的患者。符合条件的患者接受卡度尼利单抗（6 mg/kg或10 mg/kg，Q2W）+化疗（AG，Q4W）。主要终点为基于实体瘤疗效评价标准1.1版（RECIST v1.1）的客观缓解率（ORR）。结果：截至2025年10月20日，共入组59例患者（中位年龄63.1岁，61.0%为男性，74.6%为ECOG PS 1，59.3%伴有远处转移）。中位随访时间为24.7个月（范围：3.0+，27.4）。56例患者（95%）至少接受过一次基线后肿瘤评估。ORR和疾病控制率（DCR）分别为33.9%（19/56）和96.4%（54/56），局部晚期与转移性患者之间无显著差异。在局部晚期疾病患者中观察到更长的DoR和生存期。中位DoR为7.46个月（95%CI：4.07，NE）对4.80个月（95%CI：1.87，11.01）。中位PFS为11.1个月（95%CI：8.7，15.9）对7.2个月（95%CI：5.5，7.7）。中位OS为23.4个月（95%CI：14.9，NE）对10.5个月（95%CI：8.5，12.8）。治疗相关不良事件（TRAEs）发生率为100.0%，最常见的为中性粒细胞计数降低（96.6%）、贫血（89.8%）、白细胞计数降低（84.7%）、血小板计数降低（76.3%）、皮疹（52.5%）、丙氨酸氨基转移酶升高（49.2%）、天门冬氨酸氨基转移酶升高（47.5%）、脱发（45.8%）、淋巴细胞计数降低（35.6%）、发热（35.6%）、乏力（32.2%）和瘙痒（32.2%）。未发现新的安全性信号。结论：AK104联合AG在既往未经治疗的晚期PDAC患者中显示出令人鼓舞的疗效和可控的安全性。表1. 按疾病状态基于RECIST 1.1的OS和PFS 局部晚期（N=24）转移性（N=35）总计（N=59）中位PFS（月），（95% CI） 11.1（8.7，15.9） 7.2（5.5，7.7） 8.5（7.2，10.4） 6个月PFS率（%），（95% CI） 89.9（65.3，97.4） 54.2（34.2，70.5） 69.2（54.0，80.2）中位OS（月），（95% CI） 23.4（14.9，NE） 10.5（8.5，12.8） 13.8（11.5，17.7） 12个月OS率（%），（95% CI） 91.7（70.6，97.8） 40.0（24.0，55.5） 61.0（47.4，72.1） 24个月OS率（%），（95% CI） 44.1（23.5，62.8） 14.3（5.2，27.7） 26.2（15.6，38.1）

查看英文原文 English abstract

Background: PDAC is a highly lethal malignancy, with approximately 80% of patients presenting with unresectable locally advanced or metastatic disease at diagnosis. Prognosis for advanced PDAC remains poor, with limited treatment options. Cadonilimab, a PD-1/CTLA-4 bispecific antibody, has shown convincing efficacy with favorable safety profile in Phase 3 trials in gastric cancer and cervical cancer. Herein, we report preliminary efficacy and safety results of cadonilimab plus AG (gemcitabine combined with nab-paclitaxel) as the first-line treatment in patients (pts) with advanced PDAC in a phase 2 study (NCT05859750). Methods: Pts with unresectable advanced or metastatic PDAC and no prior systemic therapy were enrolled. Eligible pts received cadonilimab (6 mg/kg or 10 mg/kg, Q2W) + chemo (AG, Q4W). The primary endpoint was objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Results: As of 20 Oct 2025, 59 pts were enrolled (median age 63.1 years, 61.0% male, 74.6% ECOG PS 1, 59.3% with distant metastasis). The median follow-up time was 24.7 months (range: 3.0+, 27.4). 56 patients (95%) had at least one post-baseline tumor evaluation. The ORR and disease control rate (DCR) were 33.9% (19/56) and 96.4% (54/56), respectively, with no significant difference between locally advanced or metastatic pts. Longer DoR and survival was observed in the pts with locally advanced diseases. The median DoR was 7.46 months (95%CI: 4.07, NE) vs 4.80 months (95%CI: 1.87, 11.01). The median PFS was 11.1 months (95%CI: 8.7, 15.9) vs 7.2 months (95%CI: 5.5, 7.7). The median OS was 23.4 months (95%CI: 14.9, NE) vs 10.5 months (95%CI: 8.5, 12.8). Treatment-related adverse events (TRAEs) occurred in 100.0% of pts, and the most frequent were neutrophil count decreased (96.6%), anemia (89.8%), white blood cell count decreased (84.7%), platelet count decreased (76.3%), rash (52.5%), alanine aminotransferase increased (49.2%), aspartate aminotransferase increased (47.5%), alopecia (45.8%), lymphocyte count decreased (35.6%), pyrexia (35.6%), asthenia (32.2%), and pruritus (32.2%). No new safety signals were identified. Conclusions: AK104 in combination with AG showed encouraging efficacy and manageable safety in previously untreated pts with advanced PDAC. Table 1. OS and PFS based on RECIST 1.1 by disease status Locally advanced (N = 24 ) Metastatic (N = 35 ) Total (N= 59 ) Median PFS (months) , ( 95% CI ) 11.1 (8.7, 15.9) 7.2 (5.5, 7.7) 8.5 (7.2, 10.4) 6- month PFS Rate (%) , ( 95% CI ) 89.9 (65.3, 97.4) 54.2 (34.2, 70.5) 69.2 (54.0, 80.2) Median OS (months) , ( 95% CI ) 23.4 (14.9, NE) 10.5 (8.5, 12.8) 13.8 (11.5, 17.7) 12- month OS Rate (%) , ( 95% CI ) 91.7 (70.6, 97.8) 40.0 (24.0, 55.5) 61.0 (47.4, 72.1) 24 - month OS Rate (%) , ( 95% CI ) 44.1 (23.5, 62.8) 14.3 (5.2, 27.7) 26.2 (15.6, 38.1)

利益披露 Disclosure

W. Wu, None.. X. Hong, None.. Q. Xu, None.. G. Jin, None.. Z. Li, None.. H. Tian, None.. H. Wu, None.. Y. Mou, None.. B. Xing, None.. D. Xiu, None. Z. Yao, AkesoBiopharma,Inc., Zhongshan, China Employment. Z. Wang, AkesoBiopharma,Inc., Zhongshan, China Employment. B. Li, AkesoBiopharma,Inc., Zhongshan, China Employment. Y. Xia, AkesoBiopharma,Inc., Zhongshan, China Employment.

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