# Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4)

Source: https://onco.cc/key-papers/paper-orient-4-sintilimab-nk-t-cell-lymphoma-2021/  
OnCo record `paper-orient-4-sintilimab-nk-t-cell-lymphoma-2021` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Key paper
- Last checked: 2026-11-03
- Also known as: ORIENT-4; Tao 2021
- Tags: lymphoma-evidence-entities
- Journal: Signal Transduction and Targeted Therapy
- Year: 2021
- DOI: 10.1038/s41392-021-00768-0
- Authors: Tao R, Fan L, Song Y, et al.
- 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.
- What it means: 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.

## Sources

- Signal Transduction and Targeted Therapy 2021: https://doi.org/10.1038/s41392-021-00768-0
- PubMed: https://pubmed.ncbi.nlm.nih.gov/34702811/
- Europe PMC: https://europepmc.org/article/MED/34702811

## Connected records

- cancers: [Extranodal NK/T-cell lymphoma](https://onco.cc/cancers/extranodal-nk-t-cell-lymphoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Sintilimab](https://onco.cc/drugs/sintilimab/)
- trials: [ORIENT-4](https://onco.cc/trials/orient-4/)

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