Shots:

• The BLA submission is based on a P-III ORIENT-11 study assessing sintilimab (200mg) + pemetrexed and platinum CT vs PBO + CT as a 1L treatment for 397 patients in a ratio (2:1) with advanced or metastatic nonsq. NSCLC- with no sensitizing EGFR mutations or ALK rearrangements
• The anticipated PDUFA date for this application is in Mar’2021
• Sintilimab is currently being evaluated across multiple cancer indications. Sintilimab has two indications approved in China- three regulatory submissions under review in China- and this regulatory application under review in the US

  Ref: PRNewswire | Image: Eli Lilly