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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

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

QUAZAR® AML-001 trial design diagram QUAZAR® AML-001 trial design diagram

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

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

Baseline demographics and disease characteristics table Baseline demographics and disease characteristics table

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.

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

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

ONUREG® versus placebo overall survival probability graph ONUREG® versus placebo overall survival probability graph

*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 years4

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.