Denileukin Diftitox-CXDL Demonstrates Efficacy for Relapsed/Refractory Cutaneous T-Cell Lymphoma
Denileukin diftitox (DD)-cxdl, demonstrated efficacy and tolerability among patients with relapsed/refractory (R/R) cutaneous T-cell lymphoma (CTCL), with most patients having decreased skin tumor burden, according to results from a phase 3, multicenter, open-label, single-arm trial.
This registrational study evaluated the efficacy and safety of DD-cxdl, a fusion protein combining diphtheria toxin fragments A and B with interleukin-2, among patients with R/R CTCL who had at least 1 line of prior treatment. The primary end point was objective response rate (ORR), assessed using the Global Response Score. Secondary endpoints included duration of response, time to response, changes in skin tumor burden, as well as safety and tolerability.
Among 69 patients with R.R CTCL, the ORR was 36.2% (95% confidence interval [CI], 25.0 to 48.7). A complete response was met by 8.7% of patients. The median duration of response among all patients was 8.9 months (95% CI, 5.0 to not estimable), and the median time to response was 1.4 months (IQR, 0.7 to 2.1). Most patients (84.4%) experienced a reduction in skin tumor burden, of which 48.4% had a skin tumor burden decrease at ≥50%.
The most frequent treatment-emergent adverse events (TEAEs) were infusion reactions (73.9%), hypersensitivity (68.1%), hepatotoxicity (36.2%), and capillary leak syndrome (20.3%; grade ≥3, 5.8%), nausea (43.5%), and fatigue (31.9%).
The researchers concluded, "efficacy and safety results show that DD-cxdl would potentially fulfill a serious, unmet medical need for patients with R/R CTCL.”
Source:
Foss FM, Kim YH, Prince HM, et al. Efficacy and safety of denileukin diftitox-cxdl, an improved purity formulation of denileukin diftitox, in patients with relapsed or refractory cutaneous T-Cell lymphoma. Journal of Clinical Oncology. Published online December 19, 2024. doi: 10.1200/JCO-24-01549
