Results of a phase 1b study of venetoclax plus decitabine or azacitidine in untreated acute myeloid leukemia patients ≥ 65 years ineligible for standard induction therapy.

Abstract

7009Background: Venetoclax (VEN) is a potent, orally bioavailable BCL-2 inhibitor with single-agent activity in relapsed/refractory acute myeloid leukemia (AML) patients (pts), displaying synergistic activity with hypomethylating agents in preclinical studies. This trial evaluates VEN plus decitabine (DEC) or azacitidine (AZA) in treatment (Tx)-naive AML pts ≥ 65 y (NCT02203773). Methods: Tx-naive pts (ECOG PS ≤ 2, ≥ 65 y, intermediate- or poor-risk karyotype) not eligible for standard induction therapy received DEC (Arm A: 20 mg/m2 iv) daily on days (D) 1−5 or AZA (Arm B: 75 mg/m2; subcutaneous or iv) daily on D 1−7 of each 28-D cycle in combination with once-daily continuous oral VEN. VEN dose escalation follows a 3+3 design; 1200 mg is the final dose level. Objectives include safety, preliminary efficacy, and biomarker evaluations. Results: As of 11/28/15, 39 pts (49% male; median age 74 y [65–85 y]) have been enrolled in Arm A (n = 20) and Arm B (n = 19). Median time on study is111 D (6−375 D); 16 pts...