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AbbVie Inc Presents Preliminary Results From Phase I Study Of Investigational Oncology Compound ABT-199/GDC-0199 In Patients With High-Risk Chronic Lymphocytic Leukemia (CLL)


Monday, 17 Jun 2013 08:15am EDT 

AbbVie Inc announced preliminary results from a Phase I study of ABT-199/GDC-0199, an investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, in patients with high-risk relapsed/refractory chronic lymphocytic leukemia (CLL), and in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL). High-risk CLL patients are those with deletions of chromosome 17p or whose disease is refractory to fludarabine therapy. These data were presented at the 18th Congress of the European Hematology Association (EHA) in Stockholm, Sweden. This Phase I, open-label, multicenter, international trial was designed to assess the safety, determine the maximum tolerated dose and recommended Phase II dose, and evaluate the pharmacokinetics of ABT-199/GDC-0199 in patients with relapsed/refractory CLL and NHL. Secondary objectives included preliminary efficacy, including objective response rate, duration of response, time to progression, progression-free survival and overall survival. Preliminary efficacy results demonstrated that 13 of 16 evaluable patients (81%) with 17p deletion achieved a response to ABT-199/GDC-0199. Specifically, 2 patients (12%) achieved a complete response (CR) or complete response with incomplete bone marrow recovery and 11 patients (69%) achieved a partial response (PR). 

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