HLX04, a bevacizumab biosimilar candidate targeted at the colorectal and non–small cell lung cancer markets, met a phase 3 study primary end point, Shanghai Henlius Biotech said.
Shanghai Henlius Biotech said a trial of its bevacizumab biosimilar candidate HLX04 met its primary end point of progression-free survival at 9 months in patients with metastatic colorectal cancer (mCRC).
The randomized, double-blind multicenter phase 3 clinical trial, HLX04-mCRC03, compared the safety, efficacy, and immunogenicity of HLX04 and the reference product (Avastin) as first-line treatment in combination with oxaliplatin and fluoropyrimidine-based chemotherapy (XELOX or mFOLFOX6).
Henlius is developing HLX04 specifically for use in treating mCRC and nonsquamous non—small cell lung cancer (NSCLC). The drug is a monoclonal antibody that binds with vascular endothelial growth factor to inhibit the development of blood vessels, or angiogenesis, that support tumor growth.
There is a huge potential market for bevacizumab biosimilars in China. Colorectal cancer is the third most common malignancy in the country, with 388,000 newly diagnosed cases in 2015 and 290,000 deaths from colorectal cancer each year, according to Henlius.
By contrast, the National Cancer Institute Surveillance Epidemiology and End Results program estimates 147,950 new cases of colorectal cancer in the United States in 2020 and 53,200 deaths this year.
The originator bevacizumab has been approved in China for mCRC and advanced, metastatic, or relapsed NSCLC and achieved sales of $405 million in 2019, according to data supplied by Henlius.
The HLX04-mCRC03 trial began in April 2018 and was conducted in patients with recurrent lesions following surgery or untreated mCRC. Patients (N = 638) were randomized 1:1 to receive HLX04 or reference bevacizumab plus 1 of the 2 chemotherapy regimens until disease progression or unacceptable toxicity. Secondary outcome measures were best objective response rate, overall survival, and objective response rate.
Principal investigators for the trial were based at No. 81 Hospital of the People’s Liberation Army and Shanghai East Hospital, affiliated with Shanghai Tongji University.
On June 1, Henlius received a positive European review opinion for its trastuzumab biosimilar HLXO2 and anticipates marketing authorization for this by the end of the summer.