Preliminary Phase II Results of SGN-30 (Anti-CD30 Monoclonal Antibody) in Patients with Cutaneous Anaplastic Large Cell Lymphoma (ALCL).

Background: SGN-30 is a chimeric monoclonal antibody (mAb) directed against the CD30 antigen which is expressed on Hodgkins and non Hodgkins Lymphoma. SGN-30 has been well tolerated in phase I and phase II studies and objective responses have been seen in systemic ALCL.

Methods: Adult CD30 positive cutaneous ALCL patients who have progressed after treatment with radiotherapy and/or systemic therapy, ECOG performance status 0–2, are treated in a multicenter, single arm phase II study. SGN-30 at 4 mg/kg is administered by IV infusion monthly for a maximum of 6 consecutive doses. Evaluation of response (Physician’s Global Assessment) is performed 3–4 weeks after each infusion. In the absence of an objective response after two doses, patients may receive SGN-30 at 12 mg/kg for the remaining infusions.

Results: Patient Characteristics: 5 patients (4 male, 1 female) with median age 63 years (range 42–79) have been enrolled. Median number of prior therapies is 3 (range 1–4). All patients had at least 1 prior systemic therapy, and 3 of 5 patients (60%) had received at least two of the following therapies: Targretin, CHOP, or radiotherapy. 4 patients received 6 doses of SGN-30; of these 1 patient increased to 12 mg/kg at dose 3, 1 at dose 5, and 2 at dose 2. One patient received a single 4 mg/kg dose. Efficacy: 4 of 5 patients (80%) achieved a response; 1 CR and 3 PR (2 designated as “Marked Improvement” and 1 as “Almost Clear”). The patient with a CR had a history of Mycosis Fungoides and developed CD30+ ALCL. He had complete resolution of trunk lesions after 5 doses of SGN-30, received one additional dose of SGN-30, and maintained a durable CR of > 40 days. Of the 3 patients with PR, 1 attained a response after one dose, and 2 after 3 doses. One patient with concurrent LyP received a single dose of SGN-30 9 days after discontinuing methotrexate, experienced a worsening of his disease, and came off the study with PD. Tolerability: The most common adverse events in the 5 patients included pedal edema, arthralgia, and insomnia, each of which occurred in 2 patients. Of the 6 grade 3/4 adverse events, 4 were considered to be unrelated to SGN-30, and the relationship of 2 were unknown (pruritis and increased number of lesions). There was 1 SAE, an 80 year old male hospitalized with pneumonia after 6 doses of SGN-30 died on study of myocardial infarction secondary to aortic stenosis, considered unrelated to study drug.

Conclusions: Preliminary data indicate the drug is well tolerated and shows antitumor activity. Recruitment into the study continues.