Shots:

• The sNDA is based on the P-III (ORIENT-31) trial to evaluate sintilimab with/out bevacizumab biosimilar & CT vs PBO + CT in a ratio (1:1:1) in patients with EGFR-mutated nsq.NSCLC who had disease progression after EGFR-TKI therapy
• The results showed an improvement of IRRC-assessed PFS over sintilimab + CT & PBO + CT, improvement in ORR & DoR while safety profile was consistent with previously reported studies of sintilimab & bevacizumab biosimilar & no new or unexpected safety signals were observed & was well-tolerated
• The company is currently conducting 20+ clinical studies of sintilimab globally for cancer including 10+ registrational or pivotal clinical trials

Ref: PR Newswire | Image:Innovent