Professional Documents
Culture Documents
1University of Texas MD Anderson Cancer Center, Houston, TX; 2Medical College of Wisconsin,
Milwaukee, WI; 3City of Hope, Duarte, CA; 4Emory University, Atlanta, GA;
5Mayo Clinic, Rochester, MN; 6University of Chicago Medical Center, Chicago, IL;
7Indiana University Simmons Cancer Center, Indianapolis, IN; 8Mercy Medical Research
Institute, Springfield, IL; 9University of Texas Southwestern Medical Center, Dallas, TX;
10MEI Pharma, San Diego, CA; 11Stanford University, Stanford, CA
Abstract #100
Pracinostat + Azacitidine Introduction
Pracinostat + Azacitidine
Key Inclusion
Age 65 years
Newly diagnosed de novo, secondary, or treatment-related AML
Intermediate or unfavorable-risk cytogenetics by SWOG classification*
20% bone marrow blasts
ECOG performance 0-2
Key Exclusion
Acute promyelocytic leukemia (FAB M3); t(15;17), t(8;21), t(16;16),
del(16q), or inv(16) karyotype
Candidate for intensive chemotherapy within the next 4 months
Active CNS disease
5
Demographics and Disease Characteristics
N = 50
Age
Median (range), years 75 (66-84)
No. (%) age 75 years 26 (52%)
Bone Marrow Blasts
Median (range) 40% (20-89%)
Gender, Male 29 (58%)
ECOG Performance Status 0-1 42 (84%)
AML Presentation
De novo 33 (66%)
Secondary to MDS, MPN, or prior chemo/radiotherapy 17 (34%)
Cytogenetic risk group
Intermediate 27 (54%)
Cytogenetically normal 21 (42%)
Cytogenetically abnormal 6 (12%)
Poor* 21 (42%)
Not classified 2 (4%)
*Poor risk defined using SWOG definition, and included: Del(5q)/-5, -7/del(7q), abnormal
6 3q, 9q, 20q, 17p, t(6;9), t(9;22) and complex karyotypes ( 3 unrelated abnormalities)
Patient Disposition
N=50
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Treatment Emergent Adverse Events in 25% of Patients
All Grades (%) Grades 3-4 (%)
Hematologic
Febrile Neutropenia 24 (48) 22 (44)
Thrombocytopenia 23 (46) 23 (46)
Neutropenia 19 (38) 19 (38)
Anemia 19 (38) 15 (30)
Non-Hematologic
Nausea 39 (78) 3 (6)
Constipation 35 (70) 0
Fatigue 31 (62) 17 (34)
Decreased Appetite 28 (56) 6 (12)
Diarrhea 25 (50) 2 (4)
Vomiting 20 (40) 1 (2)
Cough 18 (36) 0
Dyspnea 17 (34) 1 (2)
Hypokalemia 17 (34) 1 (2)
Edema Peripheral 17 (34) 0
Pyrexia 17 (34) 0
Dizziness 16 (32) 0
Back Pain 14 (28) 3 (6)
Insomnia 14 (28) 0
30-day mortality: 2%
60-day mortality: 10%
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Adverse Events Leading to Drug Discontinuation (n=14)
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Overall Response
Response Assessment
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Duration of Response (CR/CRi)
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Response Assessment By Patient Subgroup
Age
75 years (N = 26) 42.3 57.7
66-74 (N = 24) 41.7 45.8
Type AML
De novo (N = 33) 42.4 51.5
Secondary (N = 17) 41.2 52.9
ECOG Performance Status
0-1 (N = 42) 40.5 50.0
2 (N = 8) 50.0 62.5
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Overall Survival
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Overall Survival by Cytogenetic Risk Group
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Overall Survival by Age
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Overall Survival in De Novo vs Secondary AML
De novo (N = 33) 13.0 months (95% CI 5.7-24.1 months)
Secondary (N = 17) 29.6 months (95% CI 14.9-29.6 months)
p-value = NS
16
Overall Survival by ECOG Performance Status
17
Pracinostat + Azacitidine in AML: Conclusions
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Acknowledgement and COI
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