Chinese biopharmaceutical company Innovent Biologics said on Monday that it has dosed the first patient under its phase III clinical trial (ORIENT-11) of sintilimab for the first-line treatment non-squamous non-small cell lung cancer (NSCLC), which accounts for about 80% to 85% of all lung cancer cases.

According to the company, Sintilimab is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-L1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is jointly developed with Eli Lilly and Company in China.

The company added that ORIENT-11 is a randomised, double-blinded, multicentre, phase III study of sintilimab or placebo combined with pemetrexed (Alimta) and platinum-based chemotherapy as first-line treatment for advanced or recurrent non-squamous non-small cell lung cancer (ns-NSCLC) in China.

Under the ORIENT-11 trial, the company plans to enroll 378 patients. The study is based on a phase Ib study that assessed the efficacy of sintilimab in combination with pemetrexed and cisplatin as first-line treatment of advanced non-squamous NSCLC.

In conjunction, the primary endpoint of the company's study is progression free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and the Independent Radiological Review Committee (IRRC). The results will be announced at the 2018 Annual Meeting of Chinese Society of Clinical Oncology (CSCO).