IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with HER2-positive breast cancer (BC) and other solid tumors: Updates from a phase 1 study.

作者：Charlotte Lemech, Yuping Sun, Adnan Nagrial, Xinhong Wu, Michelle Frances Morris, Fangling Ning, Jin Yang, Yueyin Pan, Jun Cai, Ping Lu, Tao Zhang, Fuming Qiu, Changlu Hu, Mingjun Zhang, Zhigang Liu, Guohui Han, Jianyun Nie, Christina T. Teng, Hui Zhou, Daphne Day · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.1029 · 被引用次数：1 · 研究领域：HER2/EGFR in Cancer Research、Monoclonal and Polyclonal Antibodies Research、Cancer Treatment and Pharmacology

1029 Background: HER2 has been established as an important therapeutic target for BC. IBI354 consists of trastuzumab (anti-HER2 antibody) conjugated to a camptothecin derivative. In a global, multicenter, phase 1 study, IBI354 was well tolerated and showed promising efficacy in BC and other solid tumors (2024 ESMO 345MO/720MO/576P). Here, we report updated safety and efficacy of IBI354. Methods: Eligible pts with advanced solid tumors who had failed or were intolerant to standard treatment were enrolled. Positive HER2 was defined as immunohistochemistry (IHC) 2+/in situ hybridization (ISH)+ or IHC 3+. IBI354 was administered intravenously at 6-15 mg/kg Q3W or Q2W. Primary endpoint was safety. Secondary endpoints were objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and progress-free survival (PFS) assessed by investigators per RECIST v1.1 and overall survival (OS). Results: As of Nov 12, 2024, a total of 368 pts with solid tumors were enrolled in China and Australia (females: 89.4%, median age: 56.0 years [range: 27-82], ECOG PS 1: 75.0%). Median follow-up time was 11.3 months (range: 5-19). Median treatment duration was 25.0 weeks (range: 3.1-63.3) and 124 (33.7%) pts remain on treatment. Treatment-related adverse events (TRAEs) occurred in 331 (89.9%) pts while ≥grade 3 (G3) TRAEs occurred in 93 (25.3%) pts. Most common TRAEs included white blood cell count decreased (48.6%, with 7.1% ≥G3), anemia (46.7%, with 4.9% ≥G3), nausea (46.2%, w...