# ORIENT-4

Source: https://onco.cc/trials/orient-4/  
OnCo record `orient-4` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A PD-1 antibody given alone shrank the lymphoma in three out of four people whose NK/T-cell lymphoma had come back after asparaginase chemotherapy.

## Summary

NK/T-cell lymphoma that relapses after an asparaginase-based regimen had no standard. Its tumour cells commonly express PD-L1, which is the reason PD-1 antibodies were tried. ORIENT-4 was a single-arm, multicentre phase 2 study in China that gave the PD-1 antibody sintilimab, 200 mg intravenously every three weeks for up to 24 months, to 28 patients enrolled between August 2017 and February 2018 who had failed at least one asparaginase-based regimen.

Twenty-one of the 28 (75.0 per cent, 95 per cent confidence interval 55.1 to 89.3) had an objective response by the Lugano 2014 criteria. At a median follow-up of 30.4 months median overall survival had not been reached and two-year overall survival was 78.6 per cent. Most treatment-related adverse events were grade 1 or 2, the commonest a fall in the lymphocyte count; serious adverse events occurred in seven patients and none died of an adverse event.

It is one of the studies behind the statement on the entity page that PD-1 blockade has substantial activity in relapsed disease. It is small and uncontrolled.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-11-03
- Also known as: Sintilimab in relapsed NK/T-cell lymphoma; IBI308 in extranodal NK/T-cell lymphoma
- Tags: lymphoma-evidence-entities
- Registry id: NCT03228836
- Phase: 2
- Setting: Relapsed or refractory extranodal NK/T-cell lymphoma after at least one asparaginase-based regimen: sintilimab 200 mg every three weeks for up to 24 months
- Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
- Enrolled: 28
- Result: Objective response in 21 of 28 (75.0 per cent); two-year overall survival 78.6 per cent.
- Outcomes: Objective response rate (Lugano 2014): Sintilimab 75%; Overall survival at 24 months: Sintilimab 78.6%
- Replication: Consistent with smaller reports of other PD-1 antibodies in relapsed NK/T-cell lymphoma; no randomised comparison exists.

## Sources

- ClinicalTrials.gov NCT03228836: https://clinicaltrials.gov/study/NCT03228836
- Signal Transduction and Targeted Therapy 2021: https://doi.org/10.1038/s41392-021-00768-0

## Connected records

- cancers: [Extranodal NK/T-cell lymphoma](https://onco.cc/cancers/extranodal-nk-t-cell-lymphoma/), [Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)](https://onco.cc/cancers/peripheral-t-cell-lymphoma/)
- fronts: [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- 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/)
- companies: [Innovent Biologics](https://onco.cc/companies/innovent/)
- terms: [Objective response rate (ORR)](https://onco.cc/terms/orr/)
- key papers: [Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4)](https://onco.cc/key-papers/paper-orient-4-sintilimab-nk-t-cell-lymphoma-2021/)

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JSON: https://onco.cc/api/v1/entities/orient-4.json