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Daratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an open-label, single-arm, multicenter, phase 2 study

 Huiqiang Huang  ;  Jun Zhu  ;  Ming Yao  ;  Tae Min Kim  ;  Dok Hyun Yoon  ;  Seok-Goo Cho  ;  Hyeon Seok Eom  ;  Soon Thye Lim  ;  Su-Peng Yeh  ;  Yuqin Song  ;  Yok Lam Kwong  ;  Jin Seok Kim  ;  Jie Jin  ;  Yuankai Shi  ;  HyeJin Kim  ;  Min Qing  ;  Tianyuan Zhou  ;  Grace Gao  ;  Zongqi Dong  ;  Ming Qi  ;  Won Seog Kim 
 JOURNAL OF HEMATOLOGY & ONCOLOGY, Vol.14(1) : 25, 2021-02 
Journal Title
Issue Date
Aged ; Antibodies, Monoclonal / therapeutic use* ; Antineoplastic Agents, Immunological / therapeutic use* ; Female ; Humans ; Lymphoma, Extranodal NK-T-Cell / drug therapy* ; Male ; Middle Aged ; Neoplasm Recurrence, Local / drug therapy* ; Progression-Free Survival
CD38 ; Daratumumab ; NK/T-cell lymphoma
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jin Seok(김진석) ORCID logo https://orcid.org/0000-0001-8986-8436
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