Adjunctive volasertib in patients with acute myeloid leukemia not eligible for standard induction therapy: a randomized, phase 3 trial

Döhner, 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, Jung, Chul Won, Salamero, Olga, Horst, Heinz-August, Recher, Christian, Rousselot, Philippe, Sandhu, Irwindeep, Theunissen, Koen, Thol, Felicitas, Döhner, Konstanze, Teleanu, Veronica, DeAngelo, Daniel J., Naoe, Tomoki, Sekeres, Mikkael A., Belsack, Valerie, Ge, Miaomiao, Taube, Tillmann and Ottmann, Oliver ORCID: https://orcid.org/0000-0001-9559-1330 2021. Adjunctive volasertib in patients with acute myeloid leukemia not eligible for standard induction therapy: a randomized, phase 3 trial. HemaSphere 5 (8) , e617. 10.1097/FHS9.0000000000000617

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Abstract

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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	European Hematology Association
Date of First Compliant Deposit:	17 June 2021
Date of Acceptance:	9 June 2021
Last Modified:	08 Nov 2023 09:59
URI:	https://orca.cardiff.ac.uk/id/eprint/141947

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