The approval was based on the results from the  Phase 3 results of the ORIENT-31 study of Sintilimab plus Bevacizumab and chemo vs. chemo alone for the treatment of EGFR-mutated non-squamous NSCLC patients who progressed after EGFR-TKI therapy

The second interim evaluation showed significant and clinically meaningful PFS benefits with a median PFS of 7.2 months vs. 4.3 months, in addition to this the major secondary endpoints of ORR and DOR were improved

The data cutoff date was July 4th, 2022 – the trend towards OS benefits was observed with the median OS of 21.1 months for combo vs 19.2 months for chemo

Safety signals were consistent without new safety signals