Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer

Summary

This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.

Timeline

Start

2016-11

Primary completion

2018-11-23

Completion

2021-09-28

Outcome

Met primary endpoint

paper difference of - 0.1% (95% CI - 7 to 6.9), which fell entirely in the predefined equivalence margins. PMID 33826080 ↗

release “The results have demonstrated equivalence in safety and efficacy between HLX02 and EU-trastuzumab in patients with HER2-positive recurrent or previously untreated metastatic breast cancer.” henlius.com ↗

release “has met the primary endpoint of best overall response rate (ORR) after eight cycles of therapy (Week 24， ORR24).” henlius.com ↗

release “The results of the phase 3 study demonstrated that 汉曲优® and reference trastuzumab had equivalent efficacy and similar safety results” henlius.com ↗

release “The group differences in ITT and PP sets both fell entirely in the pre-defined equivalence margins (±13.5%).” henlius.com ↗

release “The head-to-head equivalence study fully confirmed that HANQUYOU exhibited comparable long-term efficacy and safety to the reference trastuzumab.” henlius.com ↗

Publications

• Xu B, Zhang Q, Sun T, Li W, Teng Y, Hu X, Bondarenko I, Adamchuk H, Zhang L, Trukhin D, Wang S, Zheng H, Tong Z, Shparyk Y, Yang F, Yu H, Li J, Wang Q, Zhu J; HLX02-BC01 Investigators. Updated efficacy and safety of HLX02 versus reference trastuzumab in metastatic HER2-positive breast cancer: A randomized phase III equivalence trial. Breast. 2025 Apr;80:104413. doi: 10.1016/j.breast.2025.104413. Epub 2025 Feb 4.
• Xu B, Zhang Q, Sun T, Li W, Teng Y, Hu X, Bondarenko I, Adamchuk H, Zhang L, Trukhin D, Wang S, Zheng H, Tong Z, Shparyk Y, Wang Q; HLX02-BC01 Investigators. Efficacy, Safety, and Immunogenicity of HLX02 Compared with Reference Trastuzumab in Patients with Recurrent or Metastatic HER2-Positive Breast Cancer: A Randomized Phase III Equivalence Trial. BioDrugs. 2021 May;35(3):337-350. doi: 10.1007/s40259-021-00475-w. Epub 2021 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HLX02	Unknown	6 mg/kg	Intravenous
Comparator	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous

Indications