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Updated: Jul 4, 2026

Flow Cytometry-based Assay for the Monitoring of NK Cell Functions
Published on: October 30, 2016
Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4)
Rong Tao1, Lei Fan2, Yongping Song3
1Department of Hematology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Sintilimab demonstrated significant efficacy in treating relapsed/refractory extranodal NK/T cell lymphoma (ENKTL). This anti-PD-1 antibody showed a high objective response rate and favorable survival outcomes in patients with ENKTL.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Extranodal NK/T cell lymphoma (ENKTL) is an aggressive non-Hodgkin lymphoma.
- Relapsed/refractory ENKTL presents a significant unmet medical need.
- Few effective treatment options exist for patients with relapsed/refractory ENKTL.
Purpose of the Study:
- To evaluate the efficacy and safety of sintilimab in patients with relapsed/refractory ENKTL.
- To determine the objective response rate (ORR) of sintilimab in this patient population.
- To assess overall survival (OS) and treatment-related adverse events (TRAEs).
Main Methods:
- A multicenter, single-arm, phase 2 clinical trial (ORIENT-4) was conducted.
- Twenty-eight patients with relapsed/refractory ENKTL received sintilimab 200 mg intravenously every 3 weeks.
- Objective response rate was assessed using Lugano 2014 criteria.
Main Results:
- An objective response rate (ORR) of 75.0% was observed in patients treated with sintilimab.
- The 24-month overall survival (OS) rate was 78.6%.
- Most treatment-related adverse events were low-grade, with decreased lymphocyte count being the most common.
Conclusions:
- Sintilimab is an effective and well-tolerated treatment for relapsed/refractory ENKTL.
- Sintilimab represents a promising therapeutic option for ENKTL.
- Further investigation into sintilimab for ENKTL is warranted.
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