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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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ONUREG® can help your patients live longer1

In QUAZAR® AML-001, the pivotal, randomized, double-blind, phase III study, ONUREG demonstrated a statistically significant improvement vs placebo in median OS: 24.7 months (95% CI: 18.7, 30.5) vs 14.8 months (95% CI: 11.7, 17.6) , respectively (HR: 0.69 [95% CI: 0.55, 0.86; P=0.0009]).1 Review Overall Survival Data

Help your patients live longer after first AML remission1-3

Median overall survival was >2 years in patients with acute myeloid leukemia treated with ONUREG

Kaplan-Meier survival analysis comparing ONUREG vs placebo Kaplan-Meier survival analysis comparing ONUREG vs placebo

aThe efficacy of ONUREG was evaluated in QUAZAR AML-001, a multicenter, randomized, double-blind, placebo-controlled, phase III study. Eligible patients were aged 55 years or older, had AML, and were within 4 months of achieving first complete remission or complete remission with incomplete blood count recovery with intensive chemotherapy. Patients were excluded if they were candidates for hematopoietic stem cell transplantation at the time of screening. A total of 472 patients who completed induction with or without consolidation therapy were randomized 1:1 to receive ONUREG 300 mg (n=238) or placebo (n=234) orally on Days 1 through 14 of each 28-day treatment cycle. Efficacy was established on the basis of OS. The trial demonstrated a statistically significant improvement in OS for patients randomized to ONUREG compared with placebo. ONUREG (95% CI: 18.7, 30.5); placebo (95% CI: 11.7, 17.6).1Access the full study design below.
bThe 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).1
cHR for initial follow-up was 0.69 (95% CI: 0.55, 0.86; P=0.0009).1
dData cutoff for extended follow-up was September 2020.2 Median follow-up in initial dataset was 41.2 months with data cutoff July 2019.4

AML, acute myeloid leukemia; CI, confidence interval; HR, hazard ratio; ITT, intention-to-treat; OS, overall survival.

QUAZAR® AML-001 was a phase 3, multicenter, placebo-controlled trial that evaluated post-remission treatment with ONUREG1,4

QUAZAR AML-001 study design QUAZAR AML-001 study design

aNot a comprehensive list of inclusion criteria. In the trial, eligible patients were enrolled regardless of mutational status.5
bBest supportive care was permitted in both treatment groups at the discretion of the treating investigator.4
cDefined as time from randomization to death from any cause. All patients were followed until death, withdrawal of consent, or loss to follow-up.4
dDefined as time from randomization to the date of documented relapse or death form any cause, whichever occurred first.4
eAssessed as changes from baseline in patient-reported EQ-5D-3L health utility index and FACIT-Fatigue Scale scores.4

AML, acute myeloid leukemia; CR, complete remission; CRi, complete remission with incomplete blood count recovery; EQ-5D-3L, European quality of life-five dimensions-tree levels; FACIT, functional assessment of chronic illness therapy; HSCT, hematopoietic stem cell transplantation; QoL, quality of life.

ONUREG was evaluated across a broad patient population1,4

QUAZAR AML-001: select baseline demographic and disease-related characteristics1,4

Baseline characteristics table of QUAZAR AML-001 Baseline characteristics table of QUAZAR AML-001

aFor this measure, ONUREG (n=237) and placebo (n=232).7
bONUREG (n=66/236) and placebo (n=71/233).6

AML, acute myeloid leukemia; CR, complete remission; CRi, complete remission with incomplete blood count recovery; ECOG, Eastern Cooperative Oncology Group.

Help your patients with AML reach milestones4,8

Survival estimates over time Survival estimates over time

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

Kaplan-Meier methods are used to estimate survival probabilities.

CI, confidence interval; OS, overall survival.

Across select subgroups in QUAZAR AML-001

Overall survival results favored ONUREG4,7

Forest plot showing overall survival results across subgroups with ONUREG Forest plot showing overall survival results across subgroups with ONUREG

Analysis limitations: To assess differences between treatment arms, these prespecified subgroup analyses should be interpreted with caution because of potential selection bias, insufficient sample size, and a higher probability of making a false-positive finding.

aPrior MDS or CMML.

AML, acute myeloid leukemia; CI, confidence interval; CMML, chronic myelomonocytic leukemia; CR, complete remission; CRi, complete remission with incomplete blood count recovery; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; MDS, myelodysplastic syndrome; OS, overall survival.

In a retrospective, post hoc, exploratory, subgroup analysis of QUAZAR AML-001

Median overall survival was ~4 years in patients with an NPM1 mutation treated with ONUREG6,9

Graphic showing ~4 years median overall survival in patients with an NPM1 mutation treated with ONUREG. Graphic showing ~4 years median overall survival in patients with an NPM1 mutation treated with ONUREG. ~30% of patients had an NPM1 mutation at diagnosis ~30% of patients had an NPM1 mutation at diagnosis

Analysis limitations: Results should be interpreted with caution, as cohorts were not prospectively defined nor powered to detect significant differences. The analysis should not be interpreted to determine a treatment difference between arms because of potential selection bias, small sample size, and lack of statistical power. Diagnostic analyses were obtained from local investigator reports and were not confirmed by central lab assessment. 469 of 472 randomized patients were evaluable for the mutation.

aHR 0.63 (95% CI: 0.41, 0.98).9
b28.0% (66/236) and 30.5% (71/233) treated with ONUREG and placebo, respectively.6

CI, confidence interval; HR, hazard ratio; NA, not available; OS, overall survival.

In a subgroup analysis of RFS in patients with a CR at randomization in QUAZAR AML-001

Median relapse-free survival was 10.2 months in patients treated with ONUREG10

Graphic showing median relapse-free survival of 10.2 months in patients treated with ONUREG. Graphic showing median relapse-free survival of 10.2 months in patients treated with ONUREG.

Study limitations: Results should be interpreted with caution, as these cohorts were not prospectively defined, and the study was not powered to detect significant differences between subgroups.
Relapse-free survival was defined as the time from date of randomization to the date of documented relapse or death from any cause, whichever occurred first.
Patients with CRi at randomization are not included in this analysis.

CI, confidence interval; CR, complete remission; CRi, complete remission with incomplete blood count recovery; HR, hazard ratio; OS, overall survival; RFS, relapse-free survival.

Review a Quality of Life Analysis

In an exploratory analysis of QUAZAR AML-001

Patients had preserved quality of life5,7

At baseline, all patients reported generally favorable levels of HRQoL and fatigue5,7

No clinically meaningful decline in QoL measures was observed in ONUREG or placebo across visits5,7

Study limitations: This is an exploratory analysis and definitive conclusions should not be drawn. QoL data are not in the Prescribing Information and should be interpreted with caution. The completion rates, based on the number of subjects in the ITT population, declined over time for both groups, with the ONUREG® group having a significantly higher proportion of completion than the placebo group at the Cycle 4 Day 1 visit and thereafter. Additionally, HRQoL assessments were conducted on Day 1 of each 28-day treatment cycle, allowing for 14 days of recovery after each 14-day dosing period.7

HRQoL, health-related quality of life; ITT, intention-to-treat; QoL, quality of life.

Mean EQ-5D-3L scores remained at or above baseline levels at almost all assessments5,7,a

Mean EQ-5D-3L scores remained at or above baseline over 34 cycles of treatment Mean EQ-5D-3L scores remained at or above baseline over 34 cycles of treatment
  • A ≥0.08 and ≤0.10-point change from baseline defined clinically meaningful improvement and worsening, respectively.7

aData are presented up to cycle 34, the last cycle with ≥25 patients in both treatment groups.5

EQ-5D-3L limitation: The EQ-5D-3L assessment is not associated with AML or the individual patient’s treatment. This assessment is related to the individual patient’s general health status.11
The EQ-5D-3L is a generic instrument that includes a descriptive questionnaire that assesses impairment across 5 dimensions at 3 levels (no/some/extreme problems).11

CI, confidence interval; EQ-5D-3L, European quality of life-five dimensions-tree levels; HR, hazard ratio; MID, minimally important difference; OS, overall survival; SE, standard error.

Mean FACIT-Fatigue scores remained at or above baseline levels at almost all assessments5,7,a

Mean FACIT-Fatigue scores remained at or above baseline over 34 cycles of treatment Mean FACIT-Fatigue scores remained at or above baseline over 34 cycles of treatment
  • A ≥3-point change from baseline defined clinically meaningful improvement and worsening at the individual level.7

aData are presented up to cycle 34, the last cycle with ≥25 patients in both treatment groups.5

FACIT-Fatigue Scale limitation: The FACIT-Fatigue Scale is considered relevant to the disease state (AML) rather than the treatment.12
The FACIT-Fatigue Scale is a 13-item questionnaire that measures an individual’s level of fatigue during daily activities over the previous week.12

AML, acute myeloid leukemia; FACIT, functional assessment of chronic illness therapy; MID, minimally important difference; SE, standard error.

Denise wants to proactively treat her AML while it is in remission

Denise doesn’t want to wait for the AML to return. Denise doesn’t want to wait for the AML to return.

Would you prescribe ONUREG in a patient like Denise?

Denise’s treatment journey led to the initiation of ONUREG. Denise’s treatment journey led to the initiation of ONUREG.

Reasons for choosing ONUREG

  • Completed only 2 of 4 planned cycles of consolidation
    • Due to an infection and ensuing long hospitalization
  • Transplant-ineligible
  • Favorable-risk disease

AML, acute myeloid leukemia; CI, confidence interval; CR, complete remission; ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; OS, overall survival.

Explore ONUREG Safety Data

INDICATION

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ONUREG® is contraindicated in patients with known severe hypersensitivity to azacitidine or its components.

WARNINGS AND PRECAUTIONS

Risks of Substitution with Other Azacitidine Products

Due to substantial differences in the pharmacokinetic parameters, the recommended dose and schedule for ONUREG® are different from those for the intravenous or subcutaneous azacitidine products. Treatment of patients using intravenous or subcutaneous azacitidine at the recommended dosage of ONUREG® may result in a fatal adverse reaction. Treatment with ONUREG® at the doses recommended for intravenous or subcutaneous azacitidine may not be effective. Do not substitute ONUREG® for intravenous or subcutaneous azacitidine.

Myelosuppression

New or worsening Grade 3 or 4 neutropenia and thrombocytopenia occurred in 49% and 22% of patients who received ONUREG®. Febrile neutropenia occurred in 12%. A dose reduction was required for 7% and 2% of patients due to neutropenia and thrombocytopenia. Less than 1% of patients discontinued ONUREG® due to either neutropenia or thrombocytopenia. Monitor complete blood counts and modify the dosage as recommended. Provide standard supportive care, including hematopoietic growth factors, if myelosuppression occurs.

Increased Early Mortality in Patients with Myelodysplastic Syndromes (MDS)

In AZA-MDS-003, 216 patients with red blood cell transfusion-dependent anemia and thrombocytopenia due to MDS were randomized to ONUREG® or placebo. 107 received a median of 5 cycles of ONUREG® 300 mg daily for 21 days of a 28-day cycle. Enrollment was discontinued early due to a higher incidence of early fatal and/or serious adverse reactions in the ONUREG® arm compared with placebo. The most frequent fatal adverse reaction was sepsis. Safety and effectiveness of ONUREG® for MDS have not been established. Treatment of MDS with ONUREG® is not recommended outside of controlled trials.

Embryo-Fetal Toxicity

ONUREG® can cause fetal harm when administered to a pregnant woman. Azacitidine caused fetal death and anomalies in pregnant rats via a single intraperitoneal dose less than the recommended human daily dose of oral azacitidine on a mg/m2 basis. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ONUREG® and for at least 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ONUREG® and for at least 3 months after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 15% of patients who received ONUREG®. Serious adverse reactions in ≥2% included pneumonia (8%) and febrile neutropenia (7%). One fatal adverse reaction (sepsis) occurred in a patient who received ONUREG®.

Most common (≥10%) adverse reactions with ONUREG® vs placebo were nausea (65%, 24%), vomiting (60%, 10%), diarrhea (50%, 21%), fatigue/asthenia (44%, 25%), constipation (39%, 24%), pneumonia (27%, 17%), abdominal pain (22%, 13%), arthralgia (14%, 10%), decreased appetite (13%, 6%), febrile neutropenia (12%, 8%), dizziness (11%, 9%), pain in extremity (11%, 5%).

LACTATION

There are no data regarding the presence of azacitidine in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with ONUREG® and for 1 week after the last dose.

Please see full Prescribing Information for ONUREG®.

References:
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