Innovent starts Phase III of PD-1 inhibitor in squamous NSCLC after Phase Ib readout

Innovent Biologics Inc. (HKSE:1801) reported data from 17 evaluable patients with squamous non-small cell lung cancer (NSCLC) in cohort E of an open-label, Chinese Phase Ib trial showing that anti-PD-1 mAb sintilimab (IBI308) plus gemcitabine and cisplatin as first-line treatment led to an objective response rate (ORR) of 64.7% and a disease control rate (DCR) of 100%. The preliminary median duration of response was 6 months and progression-free survival (PFS) was 6.8 months at a median follow-up of 6.6 months. The 12-month overall survival (OS) rate was 87%. Data were presented at the International Association for the Study of Lung Cancer's Asia Conference on Lung Cancer in Guangzhou.

Based on the data, Innovent began the Chinese Phase III ORIENT-12 trial to evaluate sintilimab plus gemcitabine and platinum-based chemotherapy compared with placebo plus gemcitabine and chemotherapy as first-line treatment of advanced or recurrent squamous NSCLC in 348 patients. The company is also evaluating a sintilimab combination as first-line treatment of non-squamous NSCLC in the Phase III ORIENT-11 trial...