Anemia; Non-Hodgkin’s Lymphoma

June 16, 2014

AbbVie issued results of phase Ib trials of ABT-199/GDC-0199 in combination with rituximab for relapsed/refractory chronic lymphocytic leukemia (CLL) and various subtypes of non-Hodgkin’s lymphoma (NHL). The phase I, open-label, multicenter, international trial of ABT-199/GDC-0199 in patients with relapsed/refractory CLL and NHL enrolled 78 patients in the CLL arm and 62 patients in the NHL arm of the trial. In the CLL arm, due to concerns of TLS, the initial dose was reduced from 50mg to 20mg and daily dosing was modified to a weekly rampup period to the final dose of 400mg. A ramp-up period with weekly dose increases occurred from 20mg, 50mg, 100mg, 200mg to the final recommended phase II dose (RPTD) of 400mg. The overall response rate (ORR) was 77%, with 23% achieving complete response (CR). Of the 18 CR/CRi patients (complete response with incomplete blood count recovery), 11 were evaluated for minimal residual disease (MRD) and six were found to be MRD negative. The ORR for patients with 17p deletion and F-refractory CLL was 79% and 76%, respectively. ABT- 199/GDC-0199 as a monotherapy in patients with relapsed/refractory CLL harboring the 17p deletion is under investigation in an ongoing phase II clinical trial.