Innovent Biologics’ Phase 3 Orient-31 trial for sintilimab in EGFR-mutated nonsquamous NSCLC met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar) and chemotherapy, the treatment improved PFS vs. chemotherapy alone. The Orient-31 study looked into sintilimab plus Byvasda and chemotherapy as a treatment for disease that has progressed after treatment with an EGFR tyrosine kinase inhibitor.
Patients were randomized in a 1-to-1-to-1 ratio to receive the sintilimab/Byvasda/chemo combo therapy, sintilimab plus combined with chemotherapy (pemetrexed and cisplatin), or placebo combined with pemetrexed and cisplatin. The study continues until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation. Target accrual is 480 patients. The study showed no additional safety signals. Sintilimab in combination with chemotherapy demonstrated a trend of PFS benefit compared to chemotherapy alone.