Danburstotug, an anti-PD-L1 antibody, in relapsed/refractory extra-nodal natural killer/T-cell lymphoma: The phase 2 DISTINKT study.
A new antibody therapy achieves strong, durable responses in a rare aggressive lymphoma where few options previously existed, offering hope for patients with limited treatment choices.
This Phase 2 open-label study evaluated danburstotug, a novel anti-PD-L1 antibody, in 23 patients with relapsed/refractory extranodal NK/T-cell lymphoma—a rare aggressive lymphoma with very limited salvage options—achieving a 78.9% ORR and 63.2% complete response rate with 90.9% of CR patients maintaining response at 2 years. Median overall survival was 40.2 months (2-year OS 77.9%), and grade 3 serious treatment-related adverse events were limited to two patients (liver injury, uveitis), establishing danburstotug as a potentially practice-changing agent for this high unmet-need disease.
What the study was
- Study design
- Phase 2 open-label single-arm clinical trial
- Population
- Adults with relapsed/refractory extra-nodal NK/T-cell lymphoma (R/R ENKTL)
- Sample size
- 23
- Category
- Treatment Innovation
- Maturity
- Validated
- Journal
- British journal of haematology
Why it surfaced
Phase 2 trial of novel anti-PD-L1 antibody danburstotug in R/R ENKTL—a rare aggressive lymphoma with very few treatment options—demonstrates striking ORR (78.9%) and durable CR at 2 years (90.9%); this represents a major efficacy advance in a high-unmet-need population. Design quality capped at 1 for single-arm Phase 2 with small n=23.
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