In Updated Phase 3 Results, Innovent's Bevacizumab Biosimilar Shows Similarity to Avastin

During last week’s 22nd Annual Meeting of the Chinese Society of Clinical Oncology, held from September 18-22 in Xiamen, China, drug maker Innovent Biologics presented updated results for its proposed bevacizumab biosimilar, IBI305, in an oral session.

IBI305, which is being investigated as a biosimilar to the reference Avastin, is being studied in the randomized, double-blind, phase 3 clinical trial CTR20160848.

In the study, patients with advanced non—small cell lung cancer were randomized to receive either the proposed biosimilar (n = 244) or the reference bevacizumab (n = 226), plus paclitaxel/carboplatin. By the cut-off date of March 31, 2019, the independent radiology review committee–assessed overall response rates were 47.1% in the biosimilar arm and 46.8% in the reference arm.

By May 22, 2019, investigator-evaluated median progression-free survival in the biosimilar arm and the reference arm were 7.3 months and 7.5 months, respectively, with no statistically significant difference (P = .893).

The biosimilar has also been studied in 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 earlier said that this study met its primary end point of demonstrating similar pharmacokinetic profiles between the 2 drugs.

“We hope this drug can be launched on the market soon and provide more treatment options to patients," said Li Zhang, MD, Cancer Prevention and Treatment Center, Sun Yat-sen University, Guangzhou, Guangdong, China, in a statement announcing the results of the trial.

Hui Zhou, PhD, vice president and head of oncology strategy and medical sciences at Innovent, added that "Lung cancer is the malignant [tumor] with the highest morbidity and mortality in China. Currently, we have [8] registration trials in progress, [4] of which are for the treatment of lung cancer. We hope to bring more clinical benefits to patients through our efforts and address the significant unmet medical needs in China.”

Currently, Innovent is awaiting a regulatory decision from China’s National Medical Products Administration, which accepted for review a new drug application for the biosimilar in January of this year. The biosimilar is being evaluated under a priority review status. Also being reviewed by Chinese regulators is Innovent’s proposed biosimilar rituximab, IBI301.