Bevacizumab Biosimilar, IBI305, Meets Primary End Points in 2 Clinical Trials

Chinese biologics developer Innovent has announced that its proposed bevacizumab candidate, IBI305, has met its primary end points in 2 randomized, head-to-head clinical trials that compared the biosimilar to the brand-name bevacizumab (Avastin).

"Lung cancer is the highest incidence cancer in China, and bevacizumab is an important treatment for non-small lung cancer patients. The launch of a high-quality bevacizumab biosimilar will improve drug accessibility and benefit more patients," said Li Zhang, MD, from the cancer hospital of Sun Yat-Sen University, in a statement announcing the positive top-line results.

Michael Yu, founder, chairman, and CEO of Innovent, added that he hopes IBI305 can be launched soon in the Chinese market, where there are as yet no approved and launched biosimilar bevacizumab agents.

The first study of IBI305 is a randomized, multicenter, double-blind, parallel, positive-controlled phase 3 trial in 450 patients with advanced non-squamous non—small cell lung cancer (NSCLC). This trial evaluated the efficacy and safety of IBI305 versus the reference bevacizumab as first-line treatment, in combination with paclitaxel/carboplatin, for NSCLC. According to Innovent, the biosimilar met its primary end point of objective response rate.

The second trial, a randomized, double-blind, parallel, positive-controlled single-dose study, compared the pharmacokinetic profile, safety, tolerability, and immunogenicity of the biosimilar and the reference in 100 healthy volunteers. Innovent says that the study met its primary end point of demonstrating similar pharmacokinetics profiles between the 2 drugs.

Innovent has also been developing another approach to treating NSCLC, and in October 2018 was granted approval from China’s National Medical Products Administration to test a combination therapy comprising IBI305 plus sintilimab, an anti—programmed cell death protein 1 (PD-1) monoclonal antibody that has been jointly developed by Innovent and Eli Lilly.

According to Innovent, the relationship between vascular endothelial growth factor—targeted by bevacizumab—and tumor-induced immunosuppression driven by PD-1 is a promising target in both NSCLC and hepatocellular carcinoma. Abnormal tumor-induced angiogenesis appears to limit the therapeutic effect of anti—PD-1 antibodies and other immunotherapy products, and Innovent hopes the combination of sintilimab and biosimilar bevacizumab will be better able to control tumor growth by stimulating the immune system with an anti–PD-1 agent and blocking angiogenesis with bevacizumab.