SCIB1: Updated Phase I/II data

Updated data from 14 patients with stage III/IV melanoma in the Phase II portion of an open-label, U.K. Phase I/II trial showed that 4 mg SCIB1 led to a median survival of 21 months from study entry and 26 months from diagnosis of metastatic disease. The Phase II portion is evaluating SCIB1 given at weeks 0, 3, 6, 12 and 24. The trial also includes an extension phase in which patients can receive SCIB1 every 3-6 months for up to 5 years. Scancell reported initial data from the Phase II portion in December (see BioCentury, Jan. 13). The Phase II portion of the trial is also enrolling an 8 mg SCIB1 cohort of up to 13 patients.

Updated data from the Phase I portion of the trial showed that in patients who received >=3 doses of 2 or 4 mg SCIB1, median survival is 30 months from study entry and 49 months from diagnosis of metastatic disease. SCIB1 led to 1- and 2-year OS rates of 100% and 67%, respectively. In 5 patients with stage IV disease who received 8 mg SCIB1, median OS is 11 months from study entry, with 1 partial response and 1 case of stable disease. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...