{"entity":{"id":"paper-orient-4-sintilimab-nk-t-cell-lymphoma-2021","kind":"paper","name":"Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4)","aka":["ORIENT-4","Tao 2021"],"tldr":"The report of the Chinese trial in which the PD-1 antibody sintilimab produced responses in 75 per cent of people whose NK/T-cell lymphoma had relapsed after asparaginase chemotherapy.","summary":"A multicentre, single-arm phase 2 trial (NCT03228836) of sintilimab 200 mg intravenously every three weeks for up to 24 months in relapsed or refractory extranodal NK/T-cell lymphoma after at least one asparaginase-based regimen. The primary endpoint was objective response by the Lugano 2014 criteria. 28 patients were enrolled between 31 August 2017 and 7 February 2018.","asOf":"2026-11-03","links":[{"label":"Signal Transduction and Targeted Therapy 2021","url":"https://doi.org/10.1038/s41392-021-00768-0"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/34702811/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/34702811"}],"tags":["lymphoma-evidence-entities"],"related":[],"cancers":["extranodal-nk-t-cell-lymphoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["orient-4"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"Signal Transduction and Targeted Therapy","year":2021,"doi":"10.1038/s41392-021-00768-0","pmid":"34702811","authors":"Tao R, Fan L, Song Y, et al.","paperType":"observational","findings":["21 of 28 patients (75.0 per cent, 95 per cent confidence interval 55.1 to 89.3) had an objective response.","At a median follow-up of 30.4 months, median overall survival was not reached; two-year overall survival was 78.6 per cent (95 per cent confidence interval 58.4 to 89.8).","71.4 per cent of treatment-related adverse events were grade 1 or 2; the commonest was a decreased lymphocyte count (42.9 per cent).","Serious adverse events occurred in 7 patients (25.0 per cent); none died of an adverse event."],"whatItMeans":"Evidence that PD-1 blockade works after asparaginase failure in NK/T-cell lymphoma, a setting with no other standard. Single-arm and small, so it shows activity rather than a comparison with anything else.","caveats":["Single arm, 28 patients, all in China.","No comparator, so the survival figures cannot be read as a benefit over another treatment."],"participants":28},"route":"/key-papers/paper-orient-4-sintilimab-nk-t-cell-lymphoma-2021/","neighbours":{"cancer":[{"id":"extranodal-nk-t-cell-lymphoma","kind":"cancer","name":"Extranodal NK/T-cell lymphoma","route":"/cancers/extranodal-nk-t-cell-lymphoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"sintilimab","kind":"drug","name":"Sintilimab","route":"/drugs/sintilimab/"}],"trial":[{"id":"orient-4","kind":"trial","name":"ORIENT-4","route":"/trials/orient-4/"}]}}