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Henlius Presents Results from Phase 3 Clinical Study of HLX04 (Bevacizumab Biosimilar) in Patients with Metastatic Colorectal Cancer at 2021 CSCO


The 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO) is held online and in-person from 25th to 29th September 2021. In this meeting, Henlius releases phase 3 study results of HLX04 (bevacizumab biosimilar), in patients with metastatic colorectal cancer in an oral presentation. The NDA of HLX04 was accepted by NMPA in September 2020 and is expected to be approved in Q4 2021 or Q1 2022. Unlike the marketed products in China, mCRC was explored in the phase 3 clinical study of HLX04, making HLX04 the only bevacizumab biosimilar holding mCRC clinical data in China.

Details of this study are as follows:

Title: HLX04 (a bevacizumab biosimilar candidate) versus reference bevacizumab in combination with XELOX or mFOLFOX6 as first-line therapy for metastatic colorectal cancer: a randomised, double-blind phase 3 study (ID: 9949)
Leading PI: Shukui Qin, Chinese People's Liberation Army Cancer Center of Nanjing Bayi Hospital; Jin Li, Shanghai East Hospital, Tongji University
Form: Oral presentation
Presenter: Ye Guo, Shanghai East Hospital, Tongji University
Time: 2021.09.26 10:27–10:34, Parallel Session 3, Colorectal cancer immunotherapy session 2

Study design

HLX04-mCRC03 is a multi-centre, randomised, double-blind, parallel-controlled, phase 3 study (NCT03511963) aimed to compare the efficacy, safety and immunogenicity of HLX04 to reference bevacizumab in combination with chemotherapy (XELOX or mFOLFOX6) as first-line treatment in patients with metastatic colorectal cancer (mCRC). Enrolled patients were randomised (1:1) to receive either HLX04 or reference bevacizumab intravenously (7.5 mg/kg every 3 weeks when combined with XELOX or 5 mg/kg every 2 weeks when combined with mFOLFOX6). The primary endpoint was progression-free survival rate at week 36 (PFSR36wk).


Efficacy-Primary endpoint

675 patients were enrolled (FAS, HLX04, n = 338; Reference bevacizumab, n = 337). Per FAS, PFSR36wk were 46.4% in HLX04 group and 50.7% in reference bevacizumab group. The group difference was −4.2%, whose 90% CI (−10.6%, 2.1%) fell entirely in the pre-defined equivalence margins (−11%, 15%), demonstrating equivalent efficacy between HLX04 and reference bevacizumab.

Efficacy-Secondary endpoints

There was no statistically significant difference (p >0.05) between the treatment groups in secondary endpoints, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), time to response (TTR) and duration of response (DoR). 3 years OS data were updated in this report. By cut-off date of 04 April 2021, the median OS was 20.7 months (95% CI: 18.3, 23.1) in HLX04 group; the median OS was 22.4 months (95% CI: 20.1, 25.3) in reference bevacizumab group.

Safety and immunogenicity

The safety and immunogenicity profiles were similar between HLX04 and reference bevacizumab groups.


The results of the phase 3 study demonstrated the equivalence in efficacy between HLX04 and reference bevacizumab with similar safety and immunogenicity profiles as first-line treatment for mCRC patients. Moreover, the long-term follow up results further determined the clinical similarity between HLX04 and reference bevacizumab, which support the potential application of HLX04 as an alternative treatment option for suitable cancer patients.