Acute Myeloid Leukemia Coverage From Every Angle

Volasertib Plus Cytarabine in Chemotherapy-Ineligible AML: Phase III Findings

By: Kayci Reyer
Posted: Friday, October 8, 2021

According to findings from a randomized phase III trial, presented in the European Hematology Association’s journal HemaSphere, a combination treatment of the Polo-like kinase 1 inhibitor volasertib plus low-dose cytarabine may not be well tolerated or effective for some patients with acute myeloid leukemia (AML). The study’s primary and secondary endpoints were objective response rate and overall survival, respectively, among patients aged 65 and older who were ineligible for intensive chemotherapy.

“Lack of [overall survival] benefit with [volasertib plus cytarabine] versus [placebo plus cytarabine] may reflect increased early mortality with [volasertib plus cytarabine] from myelosuppression and infections,” noted Oliver G. Ottmann, MD, of Cardiff University in the United Kingdom, and colleagues.

A total of 666 patients were screened between February 25, 2013, and November 12, 2014. All 661 patients included in the trial received 20 mg of subcutaneous cytarabine twice daily on days 1 through 10 of 4-week cycles; 444 of those patients also received 350 mg of intravenous volasertib on days 1 and 15, whereas the remaining 222 patients received placebo. At the time of data cutoff, 246 patients in the volasertib arm and 125 patients in the placebo arm had been evaluated for overall response, and 356 patients in the volasertib arm and 177 patients in the placebo arm had undergone safety assessments.

In the volasertib arm, the objective response rate was 25.2%, and the median overall survival was 5.6 months. Although the objective response rate in the placebo arm was lower at 16.8%, the median overall survival was slightly higher at 6.5 months.

Fatal adverse events were significantly more common among patients receiving volasertib (31.2%) than those receiving placebo (18.0%). Infections and infestations were the most common fatal adverse events.

Disclosures: For full disclosures of the study authors, visit

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