Canadian Cancer Trials Group Bulletins

General


IND.189 Presented at the World Congress on Melanoma

Interim results of Canadian Cancer Trials Group IND.189 (A phase II study of Interleukin-21 (rIL-21) in patients with metastatic or recurrent malignant melanoma) show promising results and were recently presented at the World Congress on Melanoma in Vienna.

Interleukin 21 (IL-21) demonstrated an impressive overall response rate in the treatment of metastatic melanoma. In interim Phase II results from 24 patients, 29 percent showed a partial response, with an additional 33 percent of patients showing stable disease in this difficult to treat disease.

IND.189 is evaluating three dosing regimens of IL-21 in patients with no prior systemic therapy for metastatic melanoma. The primary endpoint is efficacy, as measured by objective response or lack of early disease progression.

To date 7 of the 24 patients (29%) had a partial response (5 confirmed by RECIST criteria). Eight patients (33%) had stable disease. The most common adverse events were mild or moderate fatigue and rash.

Two schedules testing 50 mcg/kg were evaluated in a total of 10 patients but were poorly tolerated due to adverse events including neutropenia and skin rash. The trial will be completed with a full cohort of 30 patients to be treated at the 30 mcg/kg dose, which is tolerable for outpatient dosing and active as assessed by tumor response.