HLX07 alone or combined with serplulimab, cisplatin and 5‐fluorouracil for advanced esophageal squamous cell carcinoma: A phase 2 study

作者：Yun Liu, Yanfeng Wang, Yanrong Zhu, Tao Wu, Zhenyang Liu, Jin Zhou, Yuan Yuan, Mudan Yang, Bo Liu, Zhenbo Tan, Wu Zhuang, Jiayan Chen, Ning Li, Ying Wang, Xuhui Hu, Lin Wang, Haoyu Yu, Qingyu Wang, Jun Zhu, Jing Huang · 发表于：癌症：英文版 · 年份：2024 · DOI：10.1002/cac2.12621 · 被引用次数：6 · 研究领域：Esophageal Cancer Research and Treatment、Monoclonal and Polyclonal Antibodies Research、Immunotherapy and Immune Responses

Abstract Background The combination of anti‐PD‐1 antibody serplulimab and chemotherapy is considered standard first‐line therapy for advanced esophageal squamous cell carcinoma (ESCC), but few later‐line treatments are available. Here we evaluated the therapeutic efficacy of the recombinant, humanized anti‐EGFR antibody HLX07 when used alone or together with serplulimab and chemotherapy against advanced ESCC. Methods This open‐label, non‐randomized, two‐cohort, phase 2 trial involved patients 18‐75 years old with histologically or cytologically confirmed locally advanced, unresectable, or metastatic ESCC, and an Eastern Cooperative Oncology Group performance status of 0‐1. Patients who had failed first‐line immuno‐chemotherapy or at least two lines of other systemic therapy received HLX07 monotherapy intravenously at a dose of 1,000 mg once every 2 weeks (Q2W). Patients with no prior systemic therapy received HLX07 (1,000 mg, day 1) and serplulimab (200 mg, day 1) intravenously Q2W for up to 2 years, concurrently with cisplatin (50 mg/m 2 , day 1) for up to 8 cycles and 5‐fluorouracil (1,200 mg/m 2 , days 1‐2) for up to 12 cycles intravenously Q2W. The primary endpoints were progression‐free survival (PFS) and objective response rate (ORR). Results Overall, 50 patients were enrolled. In the HLX07 monotherapy group, ORR was 15.0% (3/20), and the median PFS was 1.5 months (95% confidence interval [CI], 1.3 to 3.7). The median duration of response was not reached, and the rate o...