Tony Hagen is senior managing editor for The Center for Biosimilars®.
A Shanghai Henlius Biotech study demonstrates equivalence for its bevacizumab candidate, and Celltrion moves forward with a trial for a SARS-CoV-2 candidate.
Shanghai Henlius Biotech reported positive phase 3 clinical study data for its bevacizumab biosimilar candidate (HLX04). The trial compared the biosimilar with reference bevacizumab (Avastin) in combination with the chemotherapy regimens Xelox and mFolfox6 as a first-line treatment for metastatic colorectal cancer (mCRC).
Investigators said HLX04 demonstrated efficacy, safety, and immunogenicity equivalence to Avastin. Potential oncology indications for HLX04, besides colorectal cancer, include advanced, metastatic, or recurrent non–small cell lung cancer.
The trial, HLX04-mCRC03, was a multicenter, randomized, double-blind, parallel controlled study that randomized patients 1:1 to the biosimilar candidate (n = 338) or reference product (n = 337) delivered 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 end point was progression-free survival (PFS) at week 36.
PFS was 46.4% in the HLX04 group and 50.7% for the reference cohort. Henlius said the group difference was –4.2% and fell within predefined equivalence margins, demonstrating biosimilarity. Investigators said there was no statistically significant difference between the biosimilar candidate and reference drugs in terms of overall survival, PFS, objective response rate, time to response, or duration of response. Safety and immunogenicity profiles also were equivalent.
“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. HLX04 will provide an alternative treatment option for cancer patients as a potential biosimilar candidate,” the company said.
Henlius also aims to obtain indications for ophthalmic diseases such as wet age-related macular degeneration and diabetic retinopathy.
Biosimilar developer Celltrion Group said it has completed enrollment of 327 patients for a coronavirus disease 2019 (COVID-19) drug candidate phase 2 clinical trial. If results are positive, the company aims to apply for emergency use authorization from the Korean Ministry of Food and Drug Safety.
In preclinical studies, the agent, CT-P59, demonstrated a 100-fold reduction in viral load of SARS-CoV-2, the virus that causes COVID-19, as well as a reduction in lung inflammation.
The phase 2, randomized, double-blind, controlled trial is evaluating CT-P59 in patients with mild and moderate symptoms of COVID-19 in 3 cohorts: placebo, low concentration dose, and high concentration dose. “Results from the trial are expected in the coming weeks,” said Sang Joon Lee, senior executive vice president of Celltrion.