Hartmut Döhner, Argiris Symeonidis, Dries Deeren, Judit Demeter, Miguel A Sanz, Achilles Anagnostopoulos, Jordi Esteve, Walter Fiedler, Kimmo Porkka, Hee-Je Kim, Je-Hwan Lee, Kensuke Usuki, Stefano D'Ardia, Chul Won Jung, Olga Salamero, Heinz-August Horst, Christian Recher, Philippe Rousselot, Irwindeep Sandhu, Koen Theunissen, Felicitas Thol, Konstanze Döhner, Veronica Teleanu, Daniel J DeAngelo, Tomoki Naoe, Mikkael A Sekeres, Valerie Belsack, Miaomiao Ge, Tillmann Taube, Oliver G Ottmann
In this phase 3 trial, older patients with acute myeloid leukemia ineligible for intensive chemotherapy were randomized 2:1 to receive the polo-like kinase inhibitor, volasertib (V; 350 mg intravenous on days 1 and 15 in 4-wk cycles), combined with low-dose cytarabine (LDAC; 20 mg subcutaneous, twice daily, days 1-10; n = 444), or LDAC plus placebo (P; n = 222). Primary endpoint was objective response rate (ORR); key secondary endpoint was overall survival (OS). Primary ORR analysis at recruitment completion included patients randomized ≥5 months beforehand; ORR was 25...
August 2021: HemaSphere