NORTH CHICAGO, Ill., June 17, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV) today 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 18 th 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.
"New treatment options are critically needed for patients with hard-to-treat cancers including high risk CLL and MCL," said Gary Gordon, M.D., divisional vice president, oncology clinical development, AbbVie. "The preliminary data presented at EHA further support the ongoing clinical trial program for ABT-199/GDC-0199 via the BCL-2 pathway."
CLL ArmAs of April 2013, 56 patients have enrolled in the CLL arm of the Phase I trial, and 40 patients are currently active. Study participants were given a single oral dose of ABT-199/GDC-0199, followed by six days without medication, before continuous once-daily dosing. Due to concerns over tumor lysis syndrome (TLS), the initial dose was reduced and daily dosing was modified. Single-agent 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.