Disitamab vedotin for HER2-positive breast cancer with liver metastases: phase 3 results from the RC48-C006 phase 2/3 trial

Patients with HER2-positive advanced breast cancer with liver metastases (BCLM) have poor prognosis. Study RC48-C006 is a prospective, open-label, multi-center, randomized phase 2/3 trial (ClinicalTrials.gov identifier, NCT03500380). Based on the phase 2 results, the phase 3 stage was initiated to evaluate disitamab vedotin (DV) versus lapatinib plus capecitabine (L + C) in patients with HER2-positive BCLM who were previously treated with trastuzumab and taxanes. The results from the phase 3 stage are reported in this article. A total of 104 patients were randomized at 1:1 to receive DV (53 patients) or L + C (51 patients). Progression-free survival (PFS) assessed by the blinded Independent Review Committee (BIRC) was significantly improved with DV versus with L + C (median: 9.9 vs 4.9 months; stratified hazard ratio [HR]: 0.56 [95.48% CI, 0.35–0.91]; 2-sided P = 0.01), meeting the pre-specified primary endpoint. The investigator-assessed PFS was consistent with the BIRC assessment. Prespecified subgroup analysis of PFS consistently favored DV. Similar incidences of grade ≥3 treatment-related adverse events were reported with DV versus L + C (37.7% vs 36.0%). The present findings support DV as a treatment option for HER2-positive BCLM following trastuzumab and taxane therapy. Patients with HER2-positive breast cancer with liver metastases (BCLM) have poor prognosis. Here, the authors report phase 3 results from the phase 2/3 RC48-C006 clinical trial comparing disitamab vedotin (HER2 targeted antibody drug conjugate) against lapatinib plus capecitabine in patients with HER2-postivie breast cancer with liver metastases previously treated with trastuzumab and taxanes.

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Journal
Nature Communications
Published
2026-08-26
DOI
https://doi.org/10.1038/s41467-026-75733-y
Primary Topic
HER2/EGFR in Cancer Research
Type
article
Field-Weighted Citation Impact
0.00

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article

Disitamab vedotin for HER2-positive breast cancer with liver metastases: phase 3 results from the RC48-C006 phase 2/3 trial

Binghe Xu, Jingfen Wang, Zhaofeng Niu, Airong Wang et al.
Nature Communications
HER2/EGFR in Cancer Research
article

Disitamab vedotin for HER2-positive breast cancer with liver metastases: phase 3 results from the RC48-C006 phase 2/3 trial

Binghe Xu, Jingfen Wang, Zhaofeng Niu, Airong Wang, Ying Cheng, Xujuan Wang, Xi Yan, Herui Yao, Dandan Gao, Enxiang Zhou, Zhuangqing Yang, Quchang Ouyang, Shanshan Gu, Yuee Teng, Yanyan Hou, Zhongsheng Tong, Tao Sun, De Zeng, Yongsheng Wang, Qingyuan Zhang, Chenran Han, Xinhong Wu, Jiayu Wang, Jianying Chang, Jianmin Fang, Weimin Xie, Zerui Qu, Xiangshun Kong
article en

Abstract

Patients with HER2-positive advanced breast cancer with liver metastases (BCLM) have poor prognosis. Study RC48-C006 is a prospective, open-label, multi-center, randomized phase 2/3 trial (ClinicalTrials.gov identifier, NCT03500380). Based on the phase 2 results, the phase 3 stage was initiated to evaluate disitamab vedotin (DV) versus lapatinib plus capecitabine (L + C) in patients with HER2-positive BCLM who were previously treated with trastuzumab and taxanes. The results from the phase 3 stage are reported in this article. A total of 104 patients were randomized at 1:1 to receive DV (53 patients) or L + C (51 patients). Progression-free survival (PFS) assessed by the blinded Independent Review Committee (BIRC) was significantly improved with DV versus with L + C (median: 9.9 vs 4.9 months; stratified hazard ratio [HR]: 0.56 [95.48% CI, 0.35–0.91]; 2-sided P = 0.01), meeting the pre-specified primary endpoint. The investigator-assessed PFS was consistent with the BIRC assessment. Prespecified subgroup analysis of PFS consistently favored DV. Similar incidences of grade ≥3 treatment-related adverse events were reported with DV versus L + C (37.7% vs 36.0%). The present findings support DV as a treatment option for HER2-positive BCLM following trastuzumab and taxane therapy. Patients with HER2-positive breast cancer with liver metastases (BCLM) have poor prognosis. Here, the authors report phase 3 results from the phase 2/3 RC48-C006 clinical trial comparing disitamab vedotin (HER2 targeted antibody drug conjugate) against lapatinib plus capecitabine in patients with HER2-postivie breast cancer with liver metastases previously treated with trastuzumab and taxanes.

Nature Communications
Yuncheng University (CN), Hebei Medical University (CN), Tongji University (CN), Central South University (CN), Guiyang Medical University (CN), Harbin Medical University (CN), Sun Yat-sen University (CN), Guangxi Medical University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Sichuan University (CN), Kunming Medical University (CN), Tianjin Medical University Cancer Institute and Hospital (CN), Shantou University (CN), West China Hospital of Sichuan University (CN), Cancer Hospital of Shantou University Medical College (CN), Sun Yat-sen Memorial Hospital (CN), Linyi People's Hospital (CN), Jilin Province Tumor Hospital (CN), Guizhou Cancer Hospital (CN), Third Affiliated Hospital of Harbin Medical University (CN), Affiliated Hospital of Guizhou Medical University (CN), Xingtai People's Hospital (CN), Hunan Cancer Hospital (CN), Neijiang Normal University (CN), Weihai Municipal Hospital (CN), First Hospital of China Medical University (CN), Second Xiangya Hospital of Central South University (CN), Tumor Hospital of Guangxi Medical University (CN), Hubei Cancer Hospital (CN), Liaoning Cancer Hospital & Institute (CN), Shandong First Medical University (CN), China Medical University (CN)
Chinese Academy of Medical Sciences, National Science and Technology Major Project
Good health and well-being
Openalex Percentile: Top 13%
HER2/EGFR in Cancer Research
DOIOpen Access PDFOpenAlex
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