Abstract
This analysis from the phase II BRIGHT AML 1003 trial reports the long-term efficacy and safety of glasdegib + low-dose cytarabine (LDAC) in patients with acute myeloid leukemia ineligible for intensive chemotherapy. The multicenter, open-label study randomized (2:1) patients to receive glasdegib + LDAC (de novo, n = 38; secondary acute myeloid leukemia, n = 40) or LDAC alone (de novo, n = 18; secondary acute myeloid leukemia, n = 20). At the time of analysis, 90% of patients had died, with the longest follow-up since randomization 36 months. The combination of glasdegib and LDAC conferred superior overall survival (OS) versus LDAC alone; hazard ratio (HR) 0.495; (95% confidence interval [CI] 0.325–0.752); p = 0.0004; median OS was 8.3 versus 4.3 months. Improvement in OS was consistent across cytogenetic risk groups. In a post-hoc subgroup analysis, a survival trend with glasdegib + LDAC was observed in patients with de novo acute myeloid leukemia (HR 0.720; 95% CI 0.395–1.312; p = 0.14; median OS 6.6 vs 4.3 months) and secondary acute myeloid leukemia (HR 0.287; 95% CI 0.151–0.548; p < 0.0001; median OS 9.1 vs 4.1 months). The incidence of adverse events in the glasdegib + LDAC arm decreased after 90 days’ therapy: 83.7% versus 98.7% during the first 90 days. Glasdegib + LDAC versus LDAC alone continued to demonstrate superior OS in patients with acute myeloid leukemia; the clinical benefit with glasdegib + LDAC was particularly prominent in patients with secondary acute myeloid leukemia. ClinicalTrials.gov identifier: NCT01546038.
Highlights
Acute myeloid leukemia (AML) is the most common type of leukemia in adults [1]
Secondary AML is associated with lower response rates and decreased overall survival (OS) with standard chemotherapy compared with de novo AML [2,3,4,5,6]
Secondary AML accounts for approximately 25% of all AML cases (18–20% from a previous myeloid disease; 6–8% related to therapy) and occurs more frequently with increasing age [5, 7]
Summary
Acute myeloid leukemia (AML) is the most common type of leukemia in adults [1]. Secondary AML is associated with lower response rates and decreased overall survival (OS) with standard chemotherapy compared with de novo AML [2,3,4,5,6]. At the time of data cut-off (11 October 2018), three patients in the glasdegib + LDAC arm (de novo, n = 1; secondary AML, n = 2) had received ≥ 172 weeks of treatment and were still receiving therapy.
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