Innovent to Initiate Trial of Biosimilar Bevacizumab Plus PD-1 Inhibitor

China-based drug maker Innovent Biologics has revealed that China’s National Medical Products Administration has approved its application to test a combination therapy comprising a proposed biosimilar bevacizumab product, IBI305, plus sintilimab, an anti—programmed cell death protein 1 (PD-1) monoclonal antibody.

Innovent’s clinical trials for the combination will include patients with non—small cell lung cancer (NSCLC) and hepatocellular carcinoma.

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. 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 biosimilarbevacizumab will be better able to control tumor growth by stimulating the immune system with an anti–PD-1 agent and blocking angiogenesis with bevacizumab.

Innovent says that has completed bioequivalence studies for IBI305 in healthy volunteers, as well as a randomized, double-blind, multicenter phase 3 study in patients with NSCLC. The phase 3 study compared IBI305 with the reference Avastin.

Sintilimab, which Innovent has developed jointly with Eli Lilly, has already shown promising results as a first-line treatment for patients with NSCLC; in September 2018, Innovent presented data on sintilimab in combination with pemetrexed and cisplatin in patients with nonsquamous NSCLC during the annual meeting of the Chinese Society of Clinical Oncology. The combination, said Innovent’s researchers, demonstrated and objective response rate of 68.4%, based on 19 patients.

"It was encouraging to learn the outstanding efficacy of sintilimab in combination with pemetrexed and cisplatin for first line treatment of NSCLC. I hope to see the approval of sintilimab for first-line treatment of NSCLC in the near future, allowing more patients suffering from NSCLC to benefit from it," Caicun Zhou, MD, PhD, of the Shanghai Pulmonary Hospital, said in a statement.