Tony Hagen is senior managing editor for The Center for Biosimilars®.
Bevacizuamb biosimilar in combination with sintilimab delivered significantly improved overall survival vs sorafenib.
Bevacizumab biosimilar (Byvasda) in combination with the PD-1 inhibitor sintilimab injection (Tyvyt) has demonstrated significantly improved overall survival (OS) vs sorafenib (Nexavar) as frontline therapy in a phase 3 trial of patients with advanced unresectable hepatocellular carcinoma (HCC).
Based on the success of the randomized, open-label, multicenter ORIENT-32 trial (N = 571), Suzhou, China–based Innovent Biologics said it intends to apply to China’s National Medical Products Administration for approval of the drug combination.
“We look forward to this potentially becoming a new treatment regimen that could help more patients with HCC to live longer without their disease worsening,” said Hui Zhou, MD, vice president and head of Oncology Strategy and Medical Sciences for Innovent.
Byvasda is a recombinant humanized anti–vascular endothelial growth factor monoclonal antibody developed by Innovent and approved by the NMPA in June 2020. Tyvyt was codeveloped by Innovent and Lilly.
Interim findings also showed significantly improved progression-free survival (PFS) for the biosimilar combination. Findings from ORIENT-32 were presented at the European Society of Medical Oncology ASIA Virtual Congress 2020.
Compared with sorafenib, sintilimab injection with bevacizumab biosimilar demonstrated a 43.1% decreased risk of all-cause mortality (HR, 0.569; 95% CI, 0.431-0.751; P < .0001). Median OS was not reached in the combination arm vs 10.4 months for the sorafenib cohort, according to the independent data monitoring committee analysis.
Investigators said the combination therapy also showed a 43.5% decreased risk of progression (HR, 0.565; 95% CI, 0.455-0.701; P < .0001) by independent radiographic review committee analysis. Median PFS was 4.6 months in the combination arm vs 2.8 months in the sorafenib arm.
Investigators said the benefits of the combination therapy were consistent across all subgroups with no new safety signals. “With these results, Tyvyt plus Byvasda could potentially provide a new option for the first-line treatment of patients with advanced HCC,” investigators said.
“HCC is the fourth most common malignancy with the second highest mortality rate. More than half of new and fatal cases of HCC in the world occur in China every year,” said Zhou. “We are very pleased to see that the ORIENT-32 study demonstrated significant prolongation of OS and PFS in advanced HCC patients in China.”