Phase II Preliminary Results of SGN-30 (Anti-CD30 mAb) in Patients with CD30+ Lymphoproliferative Disorders.

SGN-30 is a monoclonal antibody directed against the CD30 antigen, a member of the TNF receptor super-family. It has been evaluated in phase II clinical trials in patients with systemic Anaplastic Large Cell Lymphoma (ALCL) and Hodgkin’s lymphoma (HL). SGN-30 has shown good tolerability and objective tumor responses in patients with systemic ALCL. This multicenter, single arm phase II study, originally designed to evaluate the tolerability and activity of SGN-30 in patients with relapsed/refractory primary cutaneous ALCL (pcALCL), was expanded to include other symptomatic CD30-positive lymphoproliferative disorders: CD30+ Lymphomatoid Papulosis (LyP) or CD30+ Large Cell Transformation of Mycosis Fungoides (t-MF) without systemic involvement. Seventeen patients (14 male, 3 female) with median age of 63 years (range 33–79) have been enrolled. The median number of prior therapies was 3 (range 1–4). All patients had received at least 1 prior systemic therapy. SGN-30 was administered at a dose of 12 mg/kg by 2-hour infusion every 2–3 weeks. Up to 3 cycles (each comprised of 6 doses of SGN-30) were given. Evaluation of response was determined by Physician’s Global Assessment (PGA) which was performed 2–3 weeks after each infusion. The best response assessment per indication is shown below:

One Grade 3 pruritis and one Grade 3 increase in the number of neoplastic lesions were reported; both were considered to be unlikely related to SGN-30. There was one SAE in which an 80 year-old male died from complications of pneumonia, MI and aortic stenosis. This SAE was considered unrelated to the study drug. Preliminary data from this phase II study indicates that SGN-30 is well tolerated and demonstrates clinical antitumor activity.