HER2-targeting antibody drug conjugate FS-1502 in HER2-expressing metastatic breast cancer: a phase 1a/1b trial

Qiao Li, Ying Cheng, Zhongsheng Tong, Yunjiang Liu, Xian Wang, Min Yan, Jianhua Chang, Shusen Wang, Caiwen Du, Liang Li, Chunjiao Wu, Mingxia Wang, Zhuo Wang, Zhuli Wu, Xingli Wang, Yongli Jin, Lei Diao, Yi Sun, Yongjiao Zhang, Ai-Min Hui and Binghe Xu ()
Additional contact information
Qiao Li: State Key Laboratory, National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Ying Cheng: Jilin Cancer Hospital
Zhongsheng Tong: Tianjin Medical University Cancer Institute and Hospital
Yunjiang Liu: The Fourth Hospital of Hebei Medical University
Xian Wang: Zhejiang University School of Medicine
Min Yan: Henan Cancer Hospital
Jianhua Chang: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shusen Wang: Sun Yat-sen University Cancer Center
Caiwen Du: Meizhou People’s Hospital
Liang Li: Meizhou People’s Hospital
Chunjiao Wu: Jilin Cancer Hospital
Mingxia Wang: The Fourth Hospital of Hebei Medical University
Zhuo Wang: Zhejiang University School of Medicine
Zhuli Wu: Ltd.
Xingli Wang: Ltd.
Yongli Jin: Ltd.
Lei Diao: Ltd.
Yi Sun: Ltd.
Yongjiao Zhang: Ltd.
Ai-Min Hui: EnCureGen Pharma
Binghe Xu: State Key Laboratory, National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Nature Communications, 2024, vol. 15, issue 1, 1-10

Abstract: Abstract Currently approved HER2-targeting antibody-drug conjugates (ADCs) for HER2-positive breast cancer (BC) are associated with safety concerns. In this multicenter, single-arm, dose-escalation (phase 1a) and dose-expansion (phase 1b) phase 1 trial (NCT03944499), patients with HER2-expressing advanced solid tumors received FS-1502 (an anti-HER2 ADC) with a 3 + 3 design in phase 1a; patients with metastatic HER2-positive BC received FS-1502 at the recommended phase 2 dose (RP2D) in phase 1b. The primary end points were dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and RP2D for phase 1a and objective response rate (ORR) for phase 1b. A total of 150 patients with HER2-expressing solid tumors (n = 5) and BC (n = 145) were enrolled (female, n = 146, 97.3%). One DLT each was reported at 3.0 and 3.5 mg/kg; the MTD was not reached. The RP2D was 2.3 mg/kg once every 3 weeks. Five (3.3%) patients experienced pneumonitis; four (2.7%) had grade 3 reversible ocular events. Of 67 HER2-positive BC patients receiving the RP2D, the best ORR was 53.7% (95% CI, 41.1-66.0%), including PRs confirmed (confirmed ORR, 37.5%) and pending for confirmation. FS-1502 was well tolerated with limited ocular and pulmonary findings and demonstrated promising antitumor activity in HER2-positive BC patients.

Date: 2024
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DOI: 10.1038/s41467-024-48798-w

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