Pivekimab sunirine shows activity in frontline and relapsed Blastic plasmacytoid dendritic cell neoplasm.
This multicenter phase I/II clinical trial assessed pivekimab sunirine in adults with frontline or relapsed/refractory Blastic plasmacytoid dendritic cell neoplasm (BPDCN). The study included 84 total patients, with a primary analysis population of 20 frontline de novo cases and 51 relapsed/refractory cases. Pivekimab sunirine was administered at 0.045 mg/kg once every 3 weeks. No comparator group was reported, and the design was open-label.
In the primary analysis population of 20 frontline de novo patients, the composite complete response (CCR) rate was 75% (15 of 20 patients; 95% CI, 51 to 91). The median duration of CCR was 10.6 months (95% CI, 3.8 to not reached), and median overall survival was 16.6 months (95% CI, 7.2 to not reached). In the relapsed/refractory population of 51 patients, the CCR rate was 14% (7 of 51 patients; 95% CI, 6 to 26), with a median overall survival of 5.8 months (95% CI, 3.9 to 8.4).
Safety data indicated common adverse events included peripheral edema (54%), fatigue (26%), and infusion-related reactions (26%). Grade 3 or higher events included neutropenia (16%), thrombocytopenia (14%), and peripheral edema (12%). Serious adverse events included pneumonia (6%) and febrile neutropenia (5%). Two cases of reversible veno-occlusive disease (VOD) occurred on treatment, and VOD was reported in five of 19 patients who proceeded to stem cell transplantation. The authors described the safety profile as manageable.
Limitations of this study include its open-label design, lack of a comparator group, and its classification as an early-phase trial. Consequently, these results are preliminary and do not support causal inference or definitive conclusions regarding comparative efficacy or long-term outcomes. Further investigation is needed to confirm these findings.
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