The efficacy and safety of a novel PD-1/CTLA-4 bispecific antibody cadonilimab (AK104) in advanced non-small cell lung cancer: A multicenter retrospective observational study.

IF 2.3 3区医学 Q3 ONCOLOGY Thoracic Cancer Pub Date : 2024-10-11 DOI:10.1111/1759-7714.15455

Hongxin Li, Wen Zhao, Chengming Li, Hongchang Shen, Meiying Li, Chengjun Wang, Chunyan Han, Cuihua Yi, Jun Wang, Xue Meng, Lian Liu, Shuwen Yu, Jisheng Li

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Abstract

Background: For patients with advanced non-small cell lung cancer (NSCLC) who have received frontline immunochemotherapy, subsequent treatment options are limited. As the first dual programmed cell death-1 (PD-1)/cytotoxic T lymphocyte-associated antigen-4 bispecific antibody approved globally, cadonilimab demonstrated potential antitumor activity in advanced NSCLC patients resistant to anti-PD-1/PD-L1 antibodies.

Methods: We retrospectively collected efficacy and safety data from advanced NSCLC patients treated with cadonilimab-based regimens in later therapy lines.

Results: A total of 41 advanced NSCLC patients refractory to anti-PD-1/PD-L1 therapy were enrolled. More than half of the patients received cadonilimab-based regimen as a fourth or later line of treatment. At the data cutoff date, treatment efficacy could be evaluated in 23 patients. One patient (4.3%) achieved partial response, eight patients (34.8%) experienced stable disease, and 14 patients (60.9%) progressed. The objective response rate and disease control rate were 4.3% and 39.1%, respectively. The median progression-free survival for all evaluated patients was 108.0 days. Due to the short follow-up period, the median overall survival has not yet been reached. Treatment-related adverse events (TRAEs) and immune-related AEs occurred in 63.4% and 22% patients, respectively. The most common TRAEs included gamma-glutamyl transferase elevation (17.1%), coughing (14.6%), and fatigue (12.2%). Five patients (12.2%) experienced grade ≥3 TRAEs.

Conclusions: In this heavily pretreated cohort of advanced NSCLC patients, cadonilimab-based regimens showed moderate antitumor efficacy with a generally tolerable and manageable safety profile. However, more evidence is needed to support the administration of cadonilimab in NSCLC patients refractory to previous anti-PD-1/PD-L1 therapy.

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新型 PD-1/CTLA-4 双特异性抗体 cadonilimab (AK104) 对晚期非小细胞肺癌的疗效和安全性：多中心回顾性观察研究。

背景：对于接受过前线免疫化疗的晚期非小细胞肺癌（NSCLC）患者来说，后续治疗方案十分有限。作为全球首个获批的程序性细胞死亡-1（PD-1）/细胞毒性T淋巴细胞相关抗原-4双特异性抗体，卡多尼单抗在抗PD-1/PD-L1抗体耐药的晚期NSCLC患者中显示出潜在的抗肿瘤活性：我们回顾性地收集了晚期NSCLC患者在后期治疗中使用卡多尼单抗治疗方案的疗效和安全性数据：共有41名抗PD-1/PD-L1疗法难治的晚期NSCLC患者入组。半数以上的患者接受了卡多尼单抗作为第四线或更后治疗线的方案。在数据截止日，有23名患者的疗效可以评估。1名患者（4.3%）获得部分应答，8名患者（34.8%）病情稳定，14名患者（60.9%）病情进展。客观反应率和疾病控制率分别为 4.3% 和 39.1%。所有接受评估的患者的无进展生存期中位数为 108.0 天。由于随访时间较短，中位总生存期尚未达到。治疗相关不良事件（TRAEs）和免疫相关不良事件分别发生在63.4%和22%的患者中。最常见的不良反应包括γ-谷氨酰转移酶升高（17.1%）、咳嗽（14.6%）和疲劳（12.2%）。5名患者（12.2%）出现了≥3级TRAE：结论：在这批接受过大量预处理的晚期NSCLC患者中，以卡多尼单抗为基础的治疗方案显示出中等抗肿瘤疗效，且安全性总体可控。然而，还需要更多证据来支持在既往抗PD-1/PD-L1疗法难治的NSCLC患者中使用卡多尼单抗。

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

Thoracic Cancer ONCOLOGY-RESPIRATORY SYSTEM

CiteScore

5.20

自引率

3.40%

发文量

439

审稿时长

2 months

期刊介绍： Thoracic Cancer aims to facilitate international collaboration and exchange of comprehensive and cutting-edge information on basic, translational, and applied clinical research in lung cancer, esophageal cancer, mediastinal cancer, breast cancer and other thoracic malignancies. Prevention, treatment and research relevant to Asia-Pacific is a focus area, but submissions from all regions are welcomed. The editors encourage contributions relevant to prevention, general thoracic surgery, medical oncology, radiology, radiation medicine, pathology, basic cancer research, as well as epidemiological and translational studies in thoracic cancer. Thoracic Cancer is the official publication of the Chinese Society of Lung Cancer, International Chinese Society of Thoracic Surgery and is endorsed by the Korean Association for the Study of Lung Cancer and the Hong Kong Cancer Therapy Society. The Journal publishes a range of article types including: Editorials, Invited Reviews, Mini Reviews, Original Articles, Clinical Guidelines, Technological Notes, Imaging in thoracic cancer, Meeting Reports, Case Reports, Letters to the Editor, Commentaries, and Brief Reports.