China-based Innovent Biologics Inc. (HKG: 1801) announced positive results from the Phase III ORIENT-31 study evaluating the combination of its PD-1 inhibitor Tyvyt (sintilimab) and Byvasda (bevacizumab biosimilar) in patients with EGFR-mutated non-squamous non-small cell lung cancer (nsqNSCLC) who have progressed after EGFR tyrosine kinase inhibitor (TKI) treatment.
The study met its primary endpoint of progression-free survival (PFS) at the first interim analysis. Innovent highlighted that this is the world’s first double-blind, multi-center, Phase III study to demonstrate significant PFS improvement using an anti-PD-1 plus anti-VEGF combination therapy for this patient population. Full details of the study can be found on ClinicalTrials.gov under NCT003802240.
Tyvyt and Byvasda Background
Tyvyt is co-developed by Innovent and Eli Lilly and was first approved in China in December 2018 for the treatment of lymphoma. The drug has also received two first-line NSCLC indication approvals, in combination with chemotherapy for both squamous and non-squamous NSCLC. Byvasda, a bevacizumab biosimilar, was approved in China in June 2020, becoming the second bevacizumab biosimilar to receive approval in the country.-Fineline Info & Tech
