h AMLDemographic and Disease
Characteristics
DAURISMO With
Low-Dose Cytarabine
(N=77)
Low-Dose Cytarabine Alone
(N=38)
Demographics
Age
Median (Min, Max) (Years)
≥ 75 years N (%)
77 (64, 92)
47 (61)
76 (58, 83)
23 (61)
Sex, N (%)
Male
Female
59 (77)
18 (23)
23 (61)
15 (39)
Race, N (%)
White
Black or African American
Asian
75 (97)
1 (1)
1 (1)
38 (100)
0 (0)
0 (0)
Disease History, N (%)
De Novo AML
Secondary AML
38 (49)
39 (51)
18 (47)
20 (53)
Prior Hypomethylating Agent Use 11 (14) 6 (16)
ECOG PSa
, N (%)
0 to 1
2
35 (46)
41 (53)
20 (53)
18 (47)
Cytogenetic Risk Status, N (%)
Good/Intermediate
Poor
48 (62)
29 (38)
21 (55)
17 (45)
Baseline Severe Cardiac Disease 51 (66) 20 (53)
Baseline Serum Creatinine >1.3 mg/dL 15 (19) 5 (13)
Abbreviations: AML = acute myeloid leukemia; N = number of patients; ECOG PS = Eastern Cooperative Oncology Group Performance Status. a Baseline ECOG PS was not reported for one patient in the DAURISMO with low-dose cytarabine arm.
Efficacy was established on the basis of overall survival (OS) from the date of randomization to death from anycause. With a median follow-up of approximately 20 months, the DAURISMO with low-dose cytarabine armwas superior to low-dose cytarabine alone arm (Figure 1).
The efficacy results are shown in Table 6.
Improvement in OS was consistent across prespecified cytogenetic risk subgroups.
Table 6. Efficacy Results From BRIGHT AML 1003
Endpoint/Study Population DAURISMO With
Low-Dose Cytarabine
Low-Dose Cytarabine Alone
OS N=77 N=38
Median survival, months (95% CI) 8.3 (4.4, 12.2) 4.3 (1.9, 5.7)
Hazard ratio (95% CI)a
0.46 (0.30, 0.71)
p-valueb
0.0002
CR N=14 N=1
CR rate (in %, 95% CI) 18.2 (10.3, 28.6) 2.6 (0.1, 13.8)
Abbreviations: AML = acute myeloid leukemia; N = number of patients; OS = overall survival; CI = confidence interval; CR = complete response. a. Hazard ratio (DAURISMO with low-dose cytarabine/low-dose cytarabine alone) based on the Cox Proportional hazards model stratified by
cytogenetic risk.
b. 1-sided p-value from log-rank test stratified by cytogenetic risk. Figure 1. BRIGHT AML 1003 – Kaplan-Meier Plot of Overall Survival for Patients with AML
Abbreviations: CI = confidence interval; OS = overall survival; LDAC = low-dose cytarabine.
16 HOW SUPPLIED/STORAGE AND HANDLING
DAURISMO is supplied in the following strengths and package configurations:
DAURISMO film-coated tablets
Package Configuration Tablet Strength (mg) NDC Print(description)
30 count bottle 100 mg 0069-1531-30
100 mg strength: 11 mm
round, pale orange
film-coated tablet
debossed with “Pfizer”
on one side and “GLS
100” on the other
60 count bottle 25 mg 0069-0298-60
25 mg strength: 7 mm
round, yellow
film-coated tablet
debossed with “Pfizer”
on one side and “GLS
25” on the other
Store at 20o
C to 25o
C (68o
F to 77o
F); excursions permitted between 15o
C to 30o
C (59o
F to 86o
F).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Advise patients of the risks of DAURISMO treatment:
Embryo-Fetal Toxicity
Advise female patients of the potential ris |
