Innovent Biologics said China's
The supplemental NDA application is based on the interim analysis of the global randomized, double-blind, multi-center phase 3 ORIENT-15 clinical trial – which evaluated sintilimab in combination with chemotherapy compared to placebo in combination with chemotherapy as first-line therapy for ESCC.
Based on the interim analysis conducted by the independent data monitoring committee, sintilimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint of overall survival compared to placebo in combination with chemotherapy, regardless of PD-L1 expression status. The results of ORIENT-15 were presented at ESMO on September 17.
In China, sintilimab has been approved for four indications, including relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy, in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer (NSCLC), in combination with gemcitabine and platinum chemotherapy for the first-line treatment of squamous NSCLC, and in combination with bevacizumab biosimilar for the first-line treatment of hepatocellular carcinoma.