Innovent Biologics, Inc. announced first interim analysis results of the randomized, double-blinded, multi-center Phase 3 ORIENT-31 study conducted in China evaluating sintilimab and anti-VEGF antibody combination therapy (i.e., sintilimab plus BYVASDA? [bevacizumab biosimilar injection] combined with chemotherapy [pemetrexed and cisplatin]) in patients with EGFR-mutated non-squamous non-small cell lung-cancer (nsqNSCLC) who progressed after EGFR-TKI therapy in an oral presentation at the ESMO (European Society for Medical Oncology) Virtual Plenary: November 2021. In the first interim analysis reviewed by the Independent Data Monitoring Committee (IDMC), in the intent-to-treat (ITT) population, based on assessment by the Independent Radiographic Review Committee (IRRC), Arm A (sintilimab plus BYVASDA?[bevacizumab biosimilar injection] in combination with chemotherapy group) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with Arm C (chemotherapy group), with a HR of 0.464 (95% CI: 0.337, 0.639; p<0.0001). The median progression-free survival (PFS) (95% CI) was 6.9 months (6.0, 9.3) in Arm A, and 4.3 months (4.1, 5.4) in Arm C. The prespecified PFS futility analysis that compares Arm A to Arm B (sintilimab and chemotherapy group) did not cross futility stopping boundary (HR=0.726, 95% CI: 0.528, 0.998). A numerical benefit of adding BYVASDA? (bevacizumab biosimilar injection) to sintilimab and chemotherapy combination was observed (based on IRRC assessment). Additionally, the key secondary endpoints of objective response rate (ORR) and duration of response (DOR) were improved in Arm A compared with Arm C, and the results of PFS, ORR and DOR assessed by the investigator were consistent with the results assessed by IRRC. The PFS data of Arm B vs Arm C was immature yet, with a numerical benefit observed as well. The safety profile of this study was consistent with that observed in previously reported studies of sintilimab and BYVASDA? (bevacizumab biosimilar injection), without new unexpected safety signals. Innovent plans to review these results and file the supplemental New Drug Application (sNDA) to the National Medical Products Administration (NMPA) in China in the near future.