LOW-DOSE CYTARABINE WITH OR WITHOUT GLASDEGIB IN NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKEMIA: LONG-TERM ANALYSIS OF A PHASE 2 RANDOMIZED TRIAL
Author(s): ,
Cristina Papayannidis
Affiliations:
Department of Experimental, Diagnostic and Specialty Medicine (DIMES),University of Bologna,Bologna,Italy
,
B. Douglas Smith
Affiliations:
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center,Baltimore, MD,United States
,
Michael Heuser
Affiliations:
Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation,Hannover Medical School,Hannover,Germany
,
Pau Montesinos
Affiliations:
Hospital Universitari i Politècnic La Fe,Valencia,Spain;CIBERONC, Instituto Carlos III,Madrid,Spain
,
Mikkael A. Sekeres
Affiliations:
Leukemia Program, Cleveland Clinic,Cleveland, OH,United States
,
Albert Oriol
Affiliations:
Institut Català d'Oncologia,Badalona,Spain
,
Gary Schiller
Affiliations:
David Geffen School of Medicine, UCLA,CA,United States
,
Anna Candoni
Affiliations:
Azienda Sanitaria Universitaria Integrata di Udine,Udine,Italy
,
Catriona Jamieson
Affiliations:
UCSD Moores Cancer Center,La Jolla, CA,United States;Sanford Stem Cell Clinical Center,La Jolla, CA,United States
,
Caroline Hoang
Affiliations:
Pfizer Inc.,New York, NY,United States
,
Weidong Wendy Ma
Affiliations:
Pfizer Inc.,New York, NY,United States
,
Mirjana Zeremski
Affiliations:
Pfizer Inc.,New York, NY,United States
,
Ashleigh O’Connell
Affiliations:
Pfizer Inc.,New York, NY,United States
,
Geoffrey Chan
Affiliations:
Pfizer Inc.,New York, NY,United States
Jorge Cortes
Affiliations:
University of Texas, MD Anderson Cancer Center,Houston, TX,United States
EHA Library. Papayannidis C. Jun 14, 2019; 266092; PF292
Dr. Cristina Papayannidis
Dr. Cristina Papayannidis
Contributions
Abstract

Abstract: PF292

Type: Poster Presentation

Presentation during EHA24: On Friday, June 14, 2019 from 17:30 - 19:00

Location: Poster area

Background
Glasdegib is a potent, selective, oral inhibitor of the Hedgehog signaling pathway, approved in the US – in combination with low-dose cytarabine (LDAC) – for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients unable to receive intensive chemotherapy due to comorbidities or age (75 years or older).

Aims
To evaluate long-term efficacy and safety of LDAC with or without glasdegib in patients newly diagnosed with AML unable to receive intensive chemotherapy due to comorbidities or age.

Methods
In this follow-up analysis from the phase 2 BRIGHT AML trial (NCT01546038), newly diagnosed patients with AML ineligible for intensive chemotherapy were randomized 2:1 to glasdegib + LDAC or LDAC alone (study design was reported previously: Cortes et al., Leukemia 2018). This long-term analysis evaluated efficacy and safety after approximately 20 months of additional follow-up.

Results
As of October 11, 2018, 116 patients were assigned to treatment with glasdegib + LDAC (n=78) or LDAC alone (n=38). The median follow-up time for glasdegib + LDAC and LDAC alone was 43.4 and 42.0 months, respectively. The median overall survival was higher with glasdegib + LDAC vs LDAC alone (Table). Improvement in overall survival was consistent across the prespecified subgroups. The main cause of death in both arms was disease progression (both during study and follow-up). The incidence of adverse events (AEs) and serious AEs on glasdegib was generally lower long term (after 90 days) than short term (during the first 90 days) (83.7% and 51.2% vs 98.7% and 65.3%, respectively).

Conclusion
Addition of glasdegib to LDAC vs LDAC alone continued to demonstrate improved overall survival in patients with AML in this analysis; improvement was consistent across groups stratified by cytogenetic risk. Long-term follow-up confirmed that treatment with glasdegib was associated with an acceptable safety profile.

Session topic: 4. Acute myeloid leukemia - Clinical

Keyword(s): Acute myeloid leukemia, Clinical outcome, Long-term follow-up

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