Innovent's PD-1 candidate under Chinese review, company reports Phase II data

Innovent Biologics Inc. (Suzhou, China) said the State Drug Administration (formerly CFDA) accepted and granted Priority Review to an NDA for sintilimab (IBI308) in April to treat relapsed or refractory classical Hodgkin's lymphoma. The company also reported preliminary data from the Phase II ORIENT-1 trial evaluating the anti-PD-1 mAb in the indication.

Among 96 patients, sintilimab led to an overall response rate (ORR) of 79.2% and a disease control rate (DCR) of 97.9%. According to the company, the results meet the preset statistical criteria. Median duration of response has not yet been reached. Final data will be presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago...