Shots:

• The P-III ORIENT-31 study evaluates sintilimab with/out Byvasda (bevacizumab biosimilar inj.) + CT vs CT alone in a ratio (1:1:1) in patients with EGFR-mutated LA or metastatic nsq.NSCLC who have progressed following EGFR TKI treatment
• The results showed an improvement in PFS at 1st interim analysis in ITT population, m-PFS (6.9mos. & 4.3mos.) with numerical benefit & 2EPs showed an improvement in ORR & DoR, PFS data was immature. The safety profile was consistent with previously reported studies of sintilimab & Byvasda (biosimilar Avastin) & no new safety signals were observed
• The company plans to file the sNDA to NMPA shortly & has 2 regulatory submissions which are accepted for review in China for sintilimab monothx. to treat ESCC

/ article | Ref: PR Newswire | Image:Innovent