Brentuximab vedotin demonstrated significant clinical activity in patients with treatment-refractory or advanced mycosis fungoides and Sézary syndrome with a wide range of CD30 expression levels, a new study published online ahead of print in the Journal of Clinical Oncology has shown.
Mycosis fungoides and Sézary syndrome are types of cutaneous T-cell lymphomas in which the lymphocytes become malignant and affect the skin, according to the National Cancer Institute.
CD30 expression levels in patients with these diseases are quite variable, as opposed to Hodgkin lymphoma and systemic anaplastic large-cell lymphoma. Therefore, researchers sought to evaluate the clinical activity and safety of brentuximab vedotin, a CD30 targeting antibody-drug conjugate, in patients with these lymphomas.
For the phase 2 study, researchers enrolled and treated 32 patients with mycosis fungoides or Sézary syndrome with brentuximab vedotin 1.8 mg/kg intravenously every 3 weeks for a maximum of 16 doses. Patients had CD300 expression levels ranging from negligible levels to 100%.
Results showed that objective global response was observed in 70% of 30 evaluable patients (90% CI: 53, 83). Researchers found that those with a CD30 expression less than 5% were less likely to achieve a global response compared with those with 5% or greater CD30 expression (P<0.005).
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In regard to safety, the most common treatment-related adverse event was peripheral neuropathy.
The authors note that additional biomarker studies are warranted to design combination therapies with brentuximab vedotin to be used in patients with these cutaneous T-cell lymphomas.