Phase III ORIENT-31 trial of Tyvyt + Byvasda meets primary endpoint in non-small cell lung cancer.

Globally, ORIENT-31 is the first prospective, double-blind, multi-center, Phase III study that has demonstrated significant PFS improvement of anti-PD-1 and anti-VEGF antibody combination therapy (i.e., sintilimab plus Byvasda [bevacizumab biosimilar injection] combined with chemotherapy [pemetrexed and cisplatin]) in patients with epidermal growth factor receptor (EGFR)-mutated nonsquamous non-small cell lung cancer (nsqNSCLC) that has progressed after treatment with an EGFR tyrosine kinase inhibitor (TKI).

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 Blinded Independent Radiographic Review Committee (BIRRC), sintilimab in combination with Byvasda (bevacizumab biosimilar injection) and chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy. Sintilimab in combination with chemotherapy also showed a trend of PFS benefit compared to chemotherapy alone (data is not yet mature). Additionally, the prespecified PFS futility analysis that compares sintilimab in combination with Byvasda (bevacizumab biosimilar injection) and chemotherapy to sintilimab in combination with chemotherapy did not cross futility stopping boundary. A numerical benefit of adding Byvasda (bevacizumab biosimilar injection) to sintilimab and chemotherapy combination can be observed. The safety profile of this study was consistent with that observed in previously reported studies of sintilimab and Byvasda (bevacizumab biosimilar injection), with no additional safety signals. The detailed results of ORIENT-31 will be presented at an upcoming medical meeting.