Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer.

作者：Zhenyu Lin, Xueli Bai, Xinjun Liang, Yu Chen, Hui Wang, Ying Wang, Qian Chu, Yuping Sun, Jian Zhang, Yueyin Pan, Huiwen Ma, Xiaoqing Liu, Liang Kang, Luyin Ding, Xun Zhang, Hongli Wang, Zheping Yuan, Hui Zhou, Tao Zhang, Tingbo Liang · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.104 · 被引用次数：6 · 研究领域：Colorectal Cancer Treatments and Studies、Colorectal Cancer Surgical Treatments、Gastric Cancer Management and Outcomes

104 Background: The prognosis of patients (pts) with microsatellite stable/proficient mismatch repair (MSS/pMMR) colorectal cancer (CRC) who failed standard chemotherapy is poor, highlighting a significant unmet need. No immune-oncology therapy has succeeded in this indication due to the "cold" tumor nature. IBI363 is a PD-1/IL-2 α-bias bispecific antibody fusion protein that blocks PD-1 and stimulates tumor-specific T cells that could potentially turn "cold" tumors into "hot" tumors. Methods: The analysis of efficacy and safety data were from 68 pts treated with IBI363 monotherapy and 73 pts treated with IBI363 plus bevacizumab (beva), respectively. Eligible pts were locally advanced unresectable or metastatic CRC who failed or were intolerant to the standard treatment. Data cutoff date was Dec 6, 2024. Results: A total of 68 pts and 73 pts (None were confirmed as microsatellite instability-high/deficient mismatch repair [MSI-H/dMMR]; MSS/pMMR: 86.8% and 90.4%; unknown microsatellite/MMR status: 13.2% and 9.6%; liver metastases: 61.8% and 54.8%; KRAS/NRAS mutations: 42.6% and 41.1%; previous treatment lines ≥ 3: 63.2% and 53.4%; previous immunotherapy: 27.9% and 16.4%) were treated with IBI363 monotherapy (0.1 mg/kg to 3 mg/kg every week [QW], every 2 weeks [Q2W] or every 3 weeks [Q3W]) and IBI363 plus beva (0.6 or 1 mg/kg Q2W, 1.5, 2 or 3 mg/kg Q3W, plus beva 5 mg/kg Q2W or 7.5 mg/kg Q3W), respectively. Median follow-up time was 11.8 months (range: 0.4–22.5) for monotherapy...