Health-Related Quality Of Life (Hrqol) In Patients With Untreated Higher-Risk Myelodysplastic Syndromes (Mds), Acute Myeloid Leukemia (Aml), And Chronic Myelomonocytic Leukemia (Cmml) Receiving Glasdegib Plus Azacitidine (Aza).

7527 Background: Glasdegib + AZA showed promising remission rates and overall survival in an analysis of BRIGHT MDS & AML 1012 in patients (pts) with MDS, AML and CMML. Here we assess the impact of glasdegib + AZA on HRQoL in this ongoing Phase Ib study. Methods: Untreated pts with MDS, AML and CMML ineligible for intensive chemotherapy received glasdegib (100 mg QD) + AZA (75 mg/m2/D on D1–7 q28D). Pt-reported outcomes (PRO) that characterize HRQoL were measured using the MD Anderson Symptom Inventory (MDASI)-AML/MDS, Pt Global Impression of Severity (PGI-S), and Pt Global Impression of Change (PGIC) tools. PRO were assessed at baseline (BL; except the PGIC), D7 and D15 of cycle (Cyc) 1, D1 of each subsequent Cyc and at end of treatment. Data cutoff: Sept 11, 2019. Results: For the MDS (n=30, including 3 with CMML) and AML (n=30) cohorts, median (range) number of Cyc started was 5 (1–14) and 5 (1–15), respectively. HRQoL over time, as determined by MDASI-AML/MDS, is shown in the Table, with mean scores indicating low symptom burden over time. For the PGI-S, both cohorts showed similar trends in pt’s impression of current leukemia symptoms remaining constant over time (i.e. absent to mild). For the PGIC, pt’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 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 pts with MDS, AML and CMML ineligible for intensive chemotherapy. Clinical trial information: NCT02367456 . [Table: see text]