Sintilimab (IBI308) in relapsed/refractory classical Hodgkin lymphoma: A multicenter, single-arm phase 2 trial in China (ORIENT-1 study).

7536Background: Classical Hodgkin’s lymphoma (cHL), characterized by chromosome 9p24.1 alteration and PD-1 ligands overexpression, is sensitive to PD-1/PD-L1 blockage in previous studies. This study will confirm the efficacy and safety of sintilimab (IBI308), a promising anti-PD-1 monoclonal antibody, in Chinese patients with relapsed/refractory (R/R) cHL. Methods: ORIENT-1 (NCT03114683) is a multicenter, single-arm, phase 2 study. Patients who failed 2 or more lines of systemic therapy, including autologous hematopoietic stem cell transplantation (HSCT) were enrolled. Sintilimab was given 200 mg intravenously every 3 weeks, until disease progression, death, unacceptable toxicity, or withdrawal from study. The primary endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) according to 2007 IWG criteria. The cut-off date for this analysis was Feb 8, 2018. Results: Among 96 treated patients enrolled between Mar 30th 2017 and Nov 1st 2017, the median number of...