Browsing by Subject "BI 6727"

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  • Dohner, Hartmut; Symeonidis, Argiris; Deeren, Dries; Demeter, Judit; Sanz, Miguel A.; Anagnostopoulos, Achilles; Esteve, Jordi; Fiedler, Walter; Porkka, Kimmo; Kim, Hee-Je; Lee, Je-Hwan; Usuki, Kensuke; D'Ardia, Stefano; Won Jung, Chul; Salamero, Olga; Horst, Heinz-August; Recher, Christian; Rousselot, Philippe; Sandhu, Irwindeep; Theunissen, Koen; Thol, Felicitas; Dohner, Konstanze; Teleanu, Veronica; DeAngelo, Daniel J.; Naoe, Tomoki; Sekeres, Mikkael A.; Belsack, Valerie; Ge, Miaomiao; Taube, Tillmann; Ottmann, Oliver G. (2021)
    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 25.2% for V+LDAC and 16.8% for P+LDAC (n = 371; odds ratio 1.66 [95% confidence interval (CI), 0.95-2.89]; P = 0.071). At final analysis (>= 574 OS events), median OS was 5.6 months for V+LDAC and 6.5 months for P+LDAC (n = 666; hazard ratio 0.97 [95% CI, 0.8-1.2]; P = 0.757). The most common adverse events (AEs) were infections/infestations (grouped term; V+LDAC, 81.3%; P+LDAC, 63.5%) and febrile neutropenia (V+LDAC, 60.4%; P+LDAC, 29.3%). Fatal AEs occurred in 31.2% with V+LDAC versus 18.0% with P+LDAC, most commonly infections/infestations (V+LDAC, 17.1%; P+LDAC, 6.3%). Lack of OS benefit with V+LDAC versus P+LDAC may reflect increased early mortality with V+LDAC from myelosuppression and infections.