JSKN003, a biparatopic anti-HER2 antibody drug conjugate (ADC), in the treatment of platinum-resistant ovarian cancer (PROC): Updated findings from two clinical trials.

作者：Xiaohua Wu, Yaqing Chen, Qunxian Rao, Jiajia Li, Bo Gao, Guixiang Weng, Zhongmin Zhang, Chunyan Lan, Dihong Tang, Kate Wilkinson, An Lin, Li Li, John Park, Xian Wang, Yongqian Shu, Qun Li, Jieqiong Liu, Jie Yang, Zhenjiu Wang, Ting Xu · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.5557 · 被引用次数：8 · 研究领域：HER2/EGFR in Cancer Research、Monoclonal and Polyclonal Antibodies Research、Ovarian cancer diagnosis and treatment

5557 Background: JSKN003 is a biparatopic HER2-targeting ADC conjugated to a topoisomerase Ⅰ inhibitor with an average DAR of 4, who has preliminarily exhibited promising efficacy and safety in the treatment of PROC (QX Rao, et al. 2024 ESMO). This update presents the latest findings in patients (pts) who were not primary platinum-refractory. Methods: A pooled analysis of pts with PROC was performed from the phase Ⅰ JSKN003-101 trial conducted in Australia (NCT05494918) and phase Ⅰ/Ⅱ JSKN003-102 trial conducted in China (NCT05744427), which enrolled pts with advanced solid tumors to receive JSKN003 monotherapy. Tumor tissue samples were collected for central lab assessment of HER2-expression. Results: As of November 29, 2024, the median follow up time was 6.9 months. A total of 46 PROC pts received JSKN003 Q3W, with 2, 2, 40, 1 and 1 pts in 4.2, 5.2, 6.3, 7.3 and 8.4 mg/kg dose groups, respectively. Median age was 59.0 years, 65.2% had ≥ 3 prior lines of systemic therapy, 80.4% and 63.0% had previously received bevacizumab and PARP inhibitor, 39.1% were classified as HER2-expressing (IHC: 1+/2+/3+), with 21.7%, 10.9% and 6.5% in 1+, 2+ and 3+, respectively; 45.7% as HER2-no-expressing (IHC: 0), and 15.2% had no tissue samples for assessment. For 45 efficacy-evaluable pts, the overall response rate (ORR) was 64.4%, the median progression-free survival (PFS) was 7.1 months, and the 9-month overall survival (OS) rate was 84.9% (Table). JSKN003 demonstrated effectiveness across v...