AML-205: Health-Related Quality of Life in Patients with Untreated Higher-Risk Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia Receiving Glasdegib + Azacitidine

Abstract

Context Glasdegib + azacitidine (AZA) showed promising remission rates and overall survival in an analysis of BRIGHT MDS & AML 1012 ( NCT02367456 ) in patients with higher-risk myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). Objective To assess the impact of glasdegib + AZA on health-related quality of life(HRQoL) in BRIGHT MDS & AML 1012. Design Phase 1b, open-label study. Data cut-off: September 11, 2019. Setting Multicenter study at centers in Europe and North America Patients Untreated patients with AML, higher-risk MDS, and CMML ineligible for intensive chemotherapy received glasdegib + AZA. Interventions Glasdegib 100 mg QD; AZA 75 mg/m2/D on D1–7 q28D. Main outcome measures Here, we report patient-reported outcomes that characterize HRQoL using the MD Anderson Symptom Inventory (MDASI)-AML/MDS, Patient Global Impression of Severity (PGI-S), and Patient Global Impression of Change (PGIC) tools. PROs were assessed at baseline (except the PGIC), D7 and D15 of cycle 1, D1 of each subsequent Cycle, and at end of treatment. Results For the MDS (n=30, including 3 with CMML) and AML (n=30) cohorts, median (range) number of cycles started was 5 (1–14) and 5 (1–15), respectively. HRQoL was measured by MDASI-AML/MDS within each of the following subscales: Core Cancer Symptoms, AML/MDS Specific Symptoms, Total Symptom Severity, and the composite score of the 6 areas of interference (general activity, mood, work, relations, walking, and enjoyment of life). For both the AML and MDS cohorts, each subscale indicated that patients had a low symptom burden over time. For the PGI-S, both cohorts showed similar trends in patient's impression of current leukemia symptoms remaining constant over time (i.e., absent to mild). For the PGIC, patient's impression of change of leukemia symptoms since starting study medication remained constant over time (i.e., no to minimal change) for the MDS cohort and showed a trend of improvement in the AML cohort (i.e., minimal change to much improved). Conclusions Glasdegib + AZA is a promising first-line treatment option that does not negatively impact the HRQoL of patients with MDS, AML, and CMML ineligible for intensive chemotherapy. Study sponsor Pfizer.