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AbbVie Presents Preliminary Results from Phase I Study of Investigational Oncology Compound ABT-199/GDC-0199 in Patients with High-Risk Chronic Lymphocytic Leukemia (CLL) at European Hematology Association Annual Meeting
Date:6/17/2013

nt activity was observed in the trial and warrants further single-agent and combination trials evaluating ABT-199/GDC-0199 in patients with CLL. Dose and schedule evaluation will continue.

Of the 56 patients enrolled, 34 were considered high-risk CLL patients – those with deletions of chromosome 17p or whose disease is refractory to fludarabine therapy. In the post-hoc analysis to determine if high-risk CLL patients could have similar response rates to the overall study population, 17 (30%) patients had 17p deletion and 18 (32%) had fludarabine-refractory CLL.

"High-risk CLL patients are a challenging subgroup to treat, as they tend to have disappointing results with conventional chemotherapy regimens," said Professor Andrew Roberts, Hematologist at the Royal Melbourne Hospital and head of Clinical Translation at the Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia.  "While still early in the development process, preliminary response rates observed in these patients appear similar to those observed in other CLL patients being treated with ABT-199/GDC-0199.  These data justify further investigation of this compound in patients with 17p deletion and fludarabine-refractory CLL."

During the study, 16 patients discontinued treatment; nine due to progressed disease and seven for other reasons (two due to TLS, three for other illnesses, one for thromboembolic event and one consent withdrawal). The most common hematological adverse events (AEs) during the study were neutropenia (39%), thrombocytopenia (18%) and anemia (13%). The most common non-hematological AEs were diarrhea (41%), nausea (38%), fatigue (29%), upper respiratory tract infection (27%) and cough (23%). In the first study group, TLS occurred in all three of the enrolled patients; once the modified dosing schedule was utilized, three of the 53 patients experienced TLS, one of which was a fatal
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