RG7601: Phase I data

Data from 54 evaluable patients in an open-label, dose-escalation, international Phase I trial showed that once-daily ABT-199 led to an overall response rate (ORR) of 85%, including 39 partial responses and 7 complete responses or complete responses with incomplete count recovery. Additionally, 14 of 16 patients with chromosome 17p deletion and 12 of 16 patients with fludarabine-refractory CLL achieved at least partial response. There were 5 cases of grade 3/4 tumor lysis syndrome, including 1 fatal adverse event in a patient receiving 1,200 mg ABT-199. Grade 3/4 adverse events occurring in >5% of patients were neutropenia, thrombocytopenia and tumor lysis syndrome. The most common non-hematological adverse events were nausea, diarrhea, fatigue, upper respiratory tract infection and cough. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...