Bevacizumab Biosimilar Demonstrates Positive Phase 3 Results for the Treatment of Non-Small Cell Lung Cancer

A study recently published in Cancer Communications reported that LY01008 or BOYOUNUO, a bevacizumab biosimilar developed by Shandong Boan Biotechnology Co., Ltd. (“Shandong Boan”), a subsidiary of Luye Pharma Group Ltd. (“Luye Pharma”), demonstrated comparable safety, efficacy, immunogenicity, and pharmacokinetic profiles to the reference product AVASTIN in patients with advanced or recurrent nonsquamous non-small cell lung cancer (NSCLC).  The phase 3 randomized double-blind clinical trial was the largest study comparing the biosimilar with AVASTIN in the first-line treatment of Chinese patients with NSCLC.  The trial included 649 NSCLC patients that were either administered BOYOUNUO (n = 324) or AVASTIN (n = 325) in combination with paclitaxel and carboplatin for 4 to 6 cycles, followed by maintenance monotherapy with the biosimilar.

BOYOUNUO is also approved in China for three other indications, including metastatic colorectal cancer, recurrent glioblastoma and hepatocellular carcinoma.