Innovent Biologics has reported positive results from two clinical trials of IBI305 after meeting the pre-defined primary endpoints of both studies.
China-based Innovent's IBI305 is a biosimilar of bevacizumab, which is a recombinant humanised anti-vascular endothelial growth factor (VEGF) monoclonal antibody developed for use as injection.
The CIBI305A301 and CIBI305A201 trials evaluated IBI305 in comparison with bevacizumab to treat advanced non-squamous non-small cell lung cancer (NSCLC), a type of epithelial lung cancer.
CIBI305A301 is a Phase III trial that evaluated the efficacy and safety of IBI305 and bevacizumab in patients with advanced non-squamous NSCLC.
The randomised, double-blinded, parallel, positive-controlled trial enrolled 450 patients and aims to compare the clinical activity and safety of IBI305 and bevacizumab in combination with paclitaxel / carboplatin.
Its primary endpoint includes objective response rate (ORR).
The CIBI305A201 trial intends to investigate the pharmacokinetic profile, safety, tolerability, and immunogenicity of IBI305 in comparison with bevacizumab.
A total of 100 subjects were included in the randomised, double-blinded, parallel, positive-controlled single-dose trial.
Primary endpoint of the trial is to compare the pharmacokinetic (PK) profile of IBI305 and bevacizumab.
Innovent Biologics founder, CEO and chairman Michael Yu said: “The current morbidity and mortality of malignant tumours in China are high, and anti-tumour treatment is a significant economic burden for millions of families.
“Anti-angiogenic drugs are effective anti-tumour treatments, but as of yet there are no approved bevacizumab biosimilars in China.
“The clinical studies of IBI305, a potential biosimilar of bevacizumab, are encouraging.”