Title |
Daratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an open-label, single-arm, multicenter, phase 2 study
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Published in |
Journal of Hematology & Oncology, February 2021
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DOI | 10.1186/s13045-020-01020-y |
Pubmed ID | |
Authors |
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 |
Abstract |
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. 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). 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. 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 1 | 33% |
Unknown | 2 | 67% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 2 | 67% |
Practitioners (doctors, other healthcare professionals) | 1 | 33% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 25 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 4 | 16% |
Other | 3 | 12% |
Student > Bachelor | 2 | 8% |
Student > Ph. D. Student | 2 | 8% |
Student > Master | 1 | 4% |
Other | 1 | 4% |
Unknown | 12 | 48% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 6 | 24% |
Biochemistry, Genetics and Molecular Biology | 3 | 12% |
Nursing and Health Professions | 2 | 8% |
Immunology and Microbiology | 1 | 4% |
Business, Management and Accounting | 1 | 4% |
Other | 0 | 0% |
Unknown | 12 | 48% |