Photo Credit: Md Babul Hosen
The following is a summary of “Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma,” published in the December 2024 issue of Oncology by Foss et al.
Denileukin diftitox-cxdl (DD-cxdl) is a fusion protein combining diphtheria toxin and interleukin-2, used to treat relapsed/refractory (R/R) cutaneous T-cell lymphoma (CTCL).
Researchers conducted a prospective study evaluating the efficacy and safety of DD-cxdl in people with relapsed/refractory CTCL.
They received DD-cxdl intravenously daily, 5 days; 9 µg/kg/d once daily every 21 days for up to 8 cycles, and the primary efficacy analysis set (PEAS) included 69 people with stage IA-IIIB CTCL who had at least 1 prior systemic therapy.
The results showed an objective response rate (ORR) of 36.2% (95% CI, 25.0 to 48.7), with 8.7% achieving complete response (CR). The median duration of response (DOR) was 8.9 months (95% CI, 5.0 to not estimable), and the median time to response (TTR) was 1.4 months (IQR, 0.7 to 2.1). Skin tumor burden decreased in 84.4% of people, with 48.4% showing a ≥50% reduction. Treatment-emergent adverse events (TEAEs) included infusion reaction (73.9%), hypersensitivity (68.1%), hepatotoxicity (36.2%), and capillary leak syndrome (20.3%, with grade ≥3, 5.8%). Other common TEAEs were nausea (43.5%) and fatigue (31.9%).
They concluded that DD-cxdl may fulfill a significant unmet medical need in people with R/R CTCL, demonstrating both efficacy and manageable safety.
Source: ascopubs.org/doi/10.1200/JCO-24-01549
