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Updated: Nov 17, 2025
Flow Cytometry-based Assay for the Monitoring of NK Cell Functions
Published on: October 30, 2016
Daratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an
Huiqiang Huang1, Jun Zhu2, Ming Yao3
1Sun Yat-Sen University Cancer Center, Guangzhou, China.
Background:
Natural killer/T-cell lymphoma (NKTCL) is a disease with limited treatment options and poor outcomes. Daratumumab monotherapy demonstrated clinical activity in a single-patient case report. We present data from the primary analysis of a phase 2 study of daratumumab monotherapy in relapsed or refractory (R/R) NKTCL.
Methods:
This phase 2 study with Simon's two-stage design evaluated daratumumab in patients with histologically confirmed extranodal NKTCL, nasal type, per WHO classification that was refractory to or relapsed after ≥ 1 line of chemotherapy, who were not candidates for other treatment modalities. All patients received daratumumab 16 mg/kg intravenously once weekly for Cycles 1 and 2, every other week for Cycles 3 through 6, and every 4 weeks thereafter until progression or unacceptable toxicity; all cycles were 28 days. The primary end point was objective response rate (ORR) based on blinded independent central review per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin Lymphoma (Lugano classification).
Results:
In total, 32 Asian patients received daratumumab. The ORR was 25.0% (95% confidence interval [CI] 11.5-43.4); all 8 responders had a partial response; and the median duration of response was 55.0 days (95% CI 29-339). At 10.2 months of median follow-up, median progression-free survival (PFS) was 53.0 days (95% CI 43-106); the 4-month PFS rate was 13.0%. Median overall survival (OS) was 141.0 days (95% CI 94-438); the 6-month OS rate was 42.9%. Nineteen (59.4%) patients had grade 3/4 treatment-emergent adverse events (TEAEs); the most common was thrombocytopenia (25.0%; n = 8). TEAEs leading to death occurred in 4 patients (death, respiratory failure, septic shock, and pneumonia); all were unrelated to daratumumab.
Conclusions:
In patients with R/R NKTCL, daratumumab monotherapy was well tolerated with no new safety concerns and achieved an ORR of 25.0%. However, no patients achieved complete response, and duration of response was short. Trial registration ClinicalTrials.gov, NCT02927925. Registered 7 October 2016.
Insights
Daratumumab monotherapy showed a 25.0% objective response rate in relapsed or refractory natural killer/T-cell lymphoma (NKTCL) patients. While generally well-tolerated, responses were short-lived, indicating a need for further treatment strategies.
Area of Science:
- Oncology
- Hematology
- Clinical Trials
Background:
- Natural killer/T-cell lymphoma (NKTCL) presents limited therapeutic options and suboptimal patient outcomes.
- Daratumumab monotherapy has shown preliminary clinical activity in a single NKTCL case report.
- This study investigates daratumumab's efficacy in relapsed or refractory (R/R) NKTCL.
Purpose of the Study:
- To evaluate the objective response rate (ORR) of daratumumab monotherapy in patients with R/R NKTCL.
- To assess the safety and tolerability of daratumumab in this patient population.
- To determine the duration of response, progression-free survival (PFS), and overall survival (OS).
Main Methods:
- A phase 2 clinical trial utilizing Simon's two-stage design was conducted.
- Patients with histologically confirmed extranodal NKTCL, nasal type, refractory to or relapsed after chemotherapy received daratumumab (16 mg/kg intravenously weekly).
- The primary endpoint was ORR assessed by blinded independent central review using Lugano classification criteria.
Main Results:
- Thirty-two Asian patients received daratumumab, achieving an ORR of 25.0% (8 partial responses).
- Median duration of response was 55.0 days; median PFS was 53.0 days; median OS was 141.0 days.
- Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 59.4% of patients, most commonly thrombocytopenia; 4 deaths were unrelated to daratumumab.
Conclusions:
- Daratumumab monotherapy demonstrated a 25.0% ORR in R/R NKTCL patients and was well-tolerated.
- No complete responses were observed, and the duration of response was limited.
- Further investigation is warranted to improve outcomes for patients with R/R NKTCL.
