Becotatug vedotin vs. chemotherapy in pre-heavily treated advanced nasopharyngeal carcinoma: A randomized, controlled, multicenter, open-label study.

作者：Fei Han, Xiaohui Wang, Yan‐Qun Xiang, Lin‐Quan Tang, Song Qu, Xiaolei Shu, Peng Zhang, Sufang Qiu, Yujuan Zhou, Ye Guo, Guiqiong Xu, Kunyu Yang, Jingao Li, Mingjun Xu, Fenghua Wang, Rui‐Hua Xu · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.17_suppl.lba6005 · 被引用次数：6 · 研究领域：Head and Neck Cancer Studies、Microbial infections and disease research、Ear and Head Tumors

LBA6005 Background: Becotatug vedotin (MRG003) is a novel EGFR-targeted antibody-drug conjugate. Previous Phase I/II studies have demonstrated optimistic efficacy in R/M NPC pts who had failed platinum chemotherapy and PD-(L)1 inhibitor. This study aimed to assess clinical efficacy and safety of MRG003 in pts compared with chemotherapy. Method: Eligible pts with R/M NPC had failed ≥2 lines of systemic chemotherapy and PD-(L)1 inhibitor, and were randomized to receive MRG003 (2.3 mg/kg, d1, iv, Q3W) or chemotherapy (capecitabine 1000 mg/m 2 , po, twice daily, d1-14, Q3W; or docetaxel 75 mg/m 2 , iv, d1, Q3W). Randomization was stratified according to liver metastasis (yes or no) and ECOG PS (0 or 1). The primary endpoints were ORR and PFS assessed by BICR, and OS. Pts in the chemotherapy arm were allowed to cross over to receive MRG003 after disease progression. Result: A total of 173 R/M NPC pts were randomly assigned to MRG003 (n=86) or capecitabine(n=36)/docetaxel (n=51). The median prior treatment lines (range) were 3 (2-10) vs. 3 (2-11), and the ECOG score 0 was 17.4% vs. 17.2% for two arms. 40 pts (46.5%) vs. 41 pts (47.1%) of two arms had liver metastasis. By 30 June 2024, the study reached the significantly improved BICR-assessed ORR with MRG003 compared to chemotherapy (30.2% vs. 11.5%, difference: 18.7%, 95%CI: 7.0%, 30.5%, P=0.0025). Also, PFS was significantly improved in the MRG003 arm (HR=0.63, 95%CI: 0.43, 0.91, P=0.0146). Median PFS (95%CI) by BICR were 5.8m (4...