Adcetris, which is an antibody-drug conjugate (ADC) directed to CD30, has not been approved for use in CTCL.
The trial enrolled 17 CTCL patients, which include 16 mycosis fungoides (MF) patients and one Sezary syndrome patient.
The primary endpoint of the trial is clinical response rate, while correlation of clinical response with CD30 expression levels, duration of response, progression-free survival and safety were included in the secondary endpoints.
The study showed a partial remission in 12 of 16 evaluable patients (75%), while median CD30 expression on lymphoid cells in biopsies of skin lesions was 15%.
It also revealed that 68% of patients maintained response at week 25, and recorded adverse events mostly of Grade 1 or 2, with the most common related events being peripheral neuropathy, followed by fatigue, decreased appetite and generalized skin.
CTCL is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis, according to the Cutaneous Lymphoma Foundation.
Adcetris is not approved for use outside the US, and the marketing authorization application for drug filed by Takeda Global Research & Development Centre (Europe) was accepted by the European Medicines Agency for review in June 2011.