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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

AE that occurred within dose escalation to 1200mg.

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). Among the patients with F-refractory CLL, 14 of 18 evaluable patients (78%) achieved a response; 3 (17%) achieved a complete response or complete response with incomplete bone marrow recovery and 11 (61%) achieved a partial response.  These results are similar to the preliminary efficacy observed in the overall CLL study population (84 percent response rate). Further clinical studies to evaluate the efficacy and safety of ABT-199/GDC-0199 in CLL, and specifically in patients with high-risk CLL, are necessary.

NHL Arm
As of April 2013, 32 patients have enrolled in the NHL arm of the trial, and 12 are currently active. Patients were given a single oral dose (50-400mg) followed by six days without medication before being dosed with continuous once-daily dosing. Due to concerns over TLS, a dose-escalation protocol was implemented. Patients who were treated with up to 900mg have been evaluated to date. Single-agent activity was observed in the trial and warrants further clinical investigation. Dose escalation will continue to determine maximum-tolerated dose and optimal dosing regimen.

The most common hematological AEs during the study were neutropenia, thrombocytopenia (16% each), and anemia (13%). The most common non-hematological AEs were nausea (41%), diarrhea (28%), dyspepsia, vomiting, fatigue, pyrexia, upper respiratory tract infection and cough (19% each). Grade 3/4 thrombocytopenia, neutropenia and anemia occurred in four patients (13% each). Grade 3/4 thrombocytopenia was not dose dependent. TLS was seen after the initial dose in one patient with bulky mantle cell lym
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