Safety and activity of sintilimab in patients with relapsed or refractory classical Hodgkin lymphoma (ORIENT-1): a multicentre, single-arm, phase 2 trial

This study is registered with ClinicalTrials.gov, number NCT03114683, and is ongoing.FindingsBetween April 19, 2017, and Nov 1, 2017, 96 patients were enrolled and commenced treatment. Four patients, whose diagnosis was not subsequently confirmed by the central pathology laboratory, were excluded from the full analysis set. Ten patients discontinued treatment. Median duration of follow-up was 10·5 months. In the full analysis set (n=92), 74 patients (80·4%; 95% CI 70·9–88·0) had an IRRC-assessed objective response before the analysis cutoff date of April 16, 2018. 89 (93%) of 96 patients had treatment-related adverse events, and 17 patients (18%) had grade 3 or 4 treatment-related adverse events, the most common being pyrexia (three [3%] patients). 14 (15%) patients had serious adverse events of any cause. No patient died during the study.InterpretationSintilimab could be a new treatment option for patients with relapsed or refractory classical Hodgkin lymphoma in China.FundingInnovent Biologics, Eli Lilly and Company, National New Drug Innovation Programme, and the National Key Scientific Programme Precision Medicine Research Fund of China.
Source: The Lancet Haematology - Category: Hematology Source Type: research