Chen Zhiwei, Wu Lin, Wang Qiming, Yu Yan, Liu Xianling, Ma Rui, Li Tao, Li Yan, Song Xia, Li Lin, Zhao Wei, Wang Qiaoyun, Xu Xiao, Lu Shun
Department of Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, People's Republic of China.
Department of Internal Thoracic Medicine, Hunan Cancer Hospital, Changsha, People's Republic of China.
J Thorac Oncol. 2025 Feb;20(2):233-239. doi: 10.1016/j.jtho.2024.10.013. Epub 2024 Oct 28.
Ivonescimab is a humanized IgG1 bispecific anti-programmed cell death protein 1/vascular endothelial growth factor antibody. This study aimed to evaluate the safety and tolerance of ivonescimab combined with etoposide and carboplatin as first-line treatment in patients with extensive-stage SCLC and to explore the primary efficacy of this regimen.
Eligible patients received intravenous ivonescimab 3 mg/kg, 10 mg/kg, or 20 mg/kg every 3 weeks combined with etoposide and carboplatin for up to four cycles, followed by ivonescimab as maintenance. The primary end points were safety and objective response rate (ORR).
Between April 23, 2021, and December 2, 2021, 35 patients were enrolled. At data cutoff (October 25, 2023), the median follow-up was 13.3 (range: 0.3-28.5) months. For all patients, the confirmed ORR and disease control rate were 80% and 91.4%, respectively. The ORR was 66.7%, 90.9%, and 76.2% at the dose of 3 mg/kg, 10 mg/kg, and 20 mg/kg, respectively. Grade more than or equal to 3 treatment-related adverse events (TRAEs) were observed in 21 patients (60%), and the most frequent toxicities were decreased neutrophil count (n = 8, 22.9%), decreased white blood cell count (n = 5, 14.3%), and anemia (n = 5, 14.3%). Grade more than or equal to 3 TRAEs occurred in 66.7%, 54.5%, and 61.9% of patients in 3, 10, and 20 mg/kg groups, respectively. TRAEs leading to death were reported in two patients (5.7%). Immune-related adverse events, most of them grade 1 or 2, occurred in 14 patients (40.0%).
Ivonescimab in combination with etoposide and carboplatin was well tolerated and found to have promising antitumor activity in extensive-stage SCLC.
伊沃西单抗是一种人源化IgG1双特异性抗程序性细胞死亡蛋白1/血管内皮生长因子抗体。本研究旨在评估伊沃西单抗联合依托泊苷和卡铂作为广泛期小细胞肺癌患者一线治疗的安全性和耐受性，并探索该方案的主要疗效。
符合条件的患者每3周接受静脉注射伊沃西单抗3mg/kg、10mg/kg或20mg/kg，联合依托泊苷和卡铂，最多进行4个周期，随后使用伊沃西单抗进行维持治疗。主要终点为安全性和客观缓解率（ORR）。
在2021年4月23日至2021年12月2日期间，共纳入35例患者。在数据截止时（2023年10月25日），中位随访时间为13.3（范围：0.3 - 28.5）个月。所有患者的确认ORR和疾病控制率分别为80%和91.4%。3mg/kg、10mg/kg和20mg/kg剂量组的ORR分别为66.7%、90.9%和76.2%。21例患者（60%）观察到≥3级治疗相关不良事件（TRAEs），最常见的毒性是中性粒细胞计数减少（n = 8，22.9%）、白细胞计数减少（n = 5，14.3%）和贫血（n = 5，14.3%）。3mg/kg、10mg/kg和20mg/kg组分别有66.7%、54.5%和61.9%的患者发生≥3级TRAEs。有2例患者（5.7%）报告了导致死亡的TRAEs。14例患者（40.0%）发生免疫相关不良事件，其中大多数为1级或2级。
伊沃西单抗联合依托泊苷和卡铂耐受性良好，在广泛期小细胞肺癌中显示出有前景的抗肿瘤活性。
