SGN-30 (Anti-CD30 Monoclonal Antibody) Is Active and Well Tolerated in Patients with Refractory or Recurrent Systemic Anaplastic Large Cell Lymphoma (ALCL).

Abstract

SGN-30 is a chimeric monoclonal antibody (mAb) directed against the CD30 antigen expressed on hematologic malignancies, notably Hodgkin's disease and ALCL. SGN-30 was well tolerated in phase I studies and objective responses were seen. In this multicenter phase II study, refractory or recurrent CD30-positive ALCL patients, ECOG performance status 0–2, are treated with SGN-30 at 6 mg/kg administered by IV over a 90 minute infusion weekly for 6 consecutive doses. A two stage statistical design provides a 90% power to detect an objective tumor response rate of at least 30%. Twenty patients (11M, 9F) with ALCL have been enrolled, with a median age of 53 (range 33–78) and 3 median prior therapies (range 2–5). Eighteen of 20 patients were Anaplastic Lymphoma Kinase (ALK) negative. Response evaluations demonstrate that one patient achieved a complete response and remains in remission more than one year after therapy. Three patients achieved a partial response, of which two had a lasting response of 27 and 53 days respectively. The third patient is currently still on treatment. Of the other 16 patients, 3 had stable disease, 10 progressed and 3 are not yet evaluable. SGN-30 has been well tolerated. Drug-related adverse events have been typically mild and consistent with the phase I experience. There were 2 grade 3/4 toxicities possibly related to SGN-30. No significant hematological or biochemical toxicities have been observed. One patient had a catheter related infection and another experienced urticaria. There was 1 definitely related grade 3/4 event in a patient who experienced an exacerbation of his cutaneous lesions after 2 doses of SGN-30 and followed by a partial response. The requisite number of responses have now been obtained to allow the study to continue.