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ONUREG® is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

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Efficacy

QUAZAR® AML-001 Trial Design Baseline Demographics Efficacy Results

The large, multicenter QUAZAR® AML-001 trial established the efficacy and safety of the first and only FDA-approved continued treatment for AML1,2

The efficacy of ONUREG® was established on the basis of overall survival1

QUAZAR® AML-001 was designed to evaluate ONUREG® vs placebo
as continued treatment for adult patients in first CR/CRi1

1:1 randomization
(N=472)
TREATMENT PHASE
Key inclusion criteria*:
  • Adults ≥55 years of age
  • Diagnosed with AML
  • Within 4 months of achieving first CR or CRi with intensive induction chemotherapy with or without consolidation therapy

*Not a comprehensive list of inclusion criteria.

ONUREG® (n=238) 300 mg orally once daily, Days 1‑14 of each 28‑day treatment cycle
Placebo (n=234) Orally once daily, Days 1‑14 of each 28‑day treatment cycle
Continue treatment
until disease progression
or unacceptable toxicity
Patients in both treatment arms received best supportive care as deemed necessary by the investigator. Prophylactic therapy for gastrointestinal (GI) or hematologic adverse events were not mandated and permitted at the discretion of the treating investigator3
QUAZAR® AML-001 Trial Design Baseline Demographics Efficacy Results

The QUAZAR® AML-001 trial enrolled a broad AML population1

Baseline demographics and disease-related characteristics in the QUAZAR® AML-001 trial1

Parameter

ONUREG®(n=238)

Placebo(n=234)

Age (years)

Median (min, max)

68.0 (55, 86)

68.0 (55, 82)

Age category, n (%)

<65 years

66 (28)

68 (29)

65 years to <75 years

144 (61)

142 (61)

≥75 years

28 (12)

24 (10)

Sex, n (%)

Male

118 (50)

127 (54)

Female

120 (50)

107 (46)

Race, n (%)

White

216 (91)

197 (84)

Black or African American

2 (1)

6 (3)

Asian

6 (3)

20 (9)

Other

12 (5)

11 (5)

Not collected or reported

2 (1)

0 (0)

ECOG performance status, n (%)

0

116 (49)

111 (47)

1

101 (42)

106 (45)

2

21 (9)

15 (6)

3

0 (0)

2 (1)

Cytogenetic risk status at diagnosis, n (%)

Intermediate risk1

203 (85)

203 (87)

Poor risk2

35 (15)

31 (13)

Initial AML classification, n (%)

AML with recurrent genetic abnormalities

39 (16)

46 (20)

AML with myelodysplasia-related changes

49 (21)

42 (18)

Therapy-related myeloid neoplasms

2 (1)

0 (0)

AML not otherwise specified

148 (62)

145 (62)

Missing

0 (0)

1 (<1)

Type of AML, n (%)

Primary (de novo)

213 (89)

216 (92)

Secondary

25 (11)

18 (8)

Induction response

CR

187 (79)

197 (84)

CRi

51 (21)

37 (16)

Received consolidation following induction therapy

None

52 (22)

42 (18)

1 cycle

110 (46)

102 (44)

2 cycles

70 (29)

77 (33)

3 cycles

6 (3)

13 (6)

Disease status at study baseline

CR

185 (78)

181 (77)

CRi

44 (18)

38 (16)

Not in CR or CRi

9 (4)

13 (6)

Not reported

0

2 (1)
72% of patients were 65 years or older
Most patients had an ECOG performance status of 0 or 1
76% of patients received 1 or 2 cycles of consolidation

ECOG, Eastern Cooperative Oncology Group.

1Intermediate risk was defined as normal cytogenetics +8, t(9;11), or other undefined.

2Poor risk was defined as complex (≥3 abnormalities): -5; 5q-; -7; 7q-; 11q23 - non t(9;11); inv(3); t(3;3); t(6;9); or t(9;22).
Source for Intermediate and Poor Risk: NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia. National Comprehensive Cancer Network® (NCCN®) website.
Available at http://www.nccn.org/professionals/physician_gls/PDF/aml.pdf. Accessed March 1, 2011.

QUAZAR® AML-001 Trial Design Baseline Demographics Efficacy Results

ONUREG® demonstrated >2 years median overall survival for AML patients in first remission1

Kaplan-Meier curve for OS: ITT population in QUAZAR® AML-0011

~10 months

longer OS with ONUREG®
vs placebo

HR† 0.69 (95% CI: 0.55, 0.86; P=0.0009)

*ONUREG® (95% CI: 18.7, 30.5); placebo (95% CI: 11.7, 17.6).

†The HR is from a Cox proportional hazards model stratified by age (55 to 64 vs ≥65 years), cytogenetic risk category at time of induction therapy (intermediate risk vs poor risk), and received consolidation therapy (yes vs no).

CI, confidence interval; ITT, intention-to-treat.

ONUREG® survival estimates
at 1 year and 2 years3

1 year

ONUREG® 73 (n=168)
(95% CI: 67, 78)
Placebo 56 (n=127)
(95% CI: 49, 62)

2 years

ONUREG® 51 (n=115)
(95% CI: 44, 57)
Placebo 37 (n=82)
(95% CI: 31, 43)

Analysis limitation

The analysis at these time points was not designed to show a difference between treatment arms.

Kaplan-Meier methods are used to estimate the 1-year and 2-year survival probabilities.

Primary endpoint subgroup analysis: treatment with ONUREG® across subgroups vs placebo for median overall survival3,4

OS select subgroup analysis

aNumber of events/number of subjects.

bMedian OS in months.

cPrior MDS and CMML.

Analysis limitations

These prespecified subgroup analyses should be interpreted with caution to determine a difference between arms in these select subgroups because of potential selection bias, insufficient sample size, and a higher probability of making a false positive finding.

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