China-based Innovent Biologics, Inc. (HKG: 1801) presented results of the ORIENT-31 study for its PD-1 inhibitor Tyvyt (sintilimab) at the 2022 European Society for Medical Oncology (ESMO) annual meeting. The study evaluated Tyvyt, with or without Bevagen (bevacizumab), a biosimilar version of Avastin, in combination with chemotherapy for EGFR-mutant non-squamous non-small cell lung cancer (nsqNSCLC) that has progressed after EGFR-TKI treatment.
Study Design and Results
The randomized, double-blind, multi-center Phase III study (NCT03802240) assessed the efficacy and safety of Tyvyt in combination with or without Bevagen and chemotherapy. The second interim analysis showed that the median progression-free survival (PFS) for Tyvyt + Bevagen + chemotherapy (group A) was 7.2 months, Tyvyt + chemotherapy (group B) was 5.5 months, and chemotherapy alone (control group C) was 4.3 months. Group A’s PFS benefit was consistent with the first interim analysis, while group B achieved a significant and clinically meaningful median PFS prolongation, meeting the pre-set superiority criteria. There were also improvements in objective response rate (ORR) and duration of response (DOR).
Significance of the Study
The ORIENT-31 study is the first prospective, double-blind Phase III study to demonstrate that a PD-1 inhibitor ± Bevagen combined with chemotherapy can significantly prolong PFS in patients with EGFR-mutant nsqNSCLC who have failed EGFR-TKI therapy. The safety profile of Tyvyt and Bevagen was consistent with previous clinical research, with no new safety signals reported.
Background
Tyvyt was first approved in China in December 2018 and has been approved for six indications. Co-developed with US-based Eli Lilly, Tyvyt has been the subject of over 20 clinical studies and was included in the National Reimbursement Drug List (NRDL) in 2019. Roche’s Avastin was first approved in China in February 2010 and entered the NRDL in 2017.-Fineline Info & Tech
