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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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Remission is the starting point1

Remission is the first milestone for patients with acute myeloid leukemia1

All patients with AML are at risk for relapse All patients with AML are at risk for relapse AML is the most-deadly leukemia AML is the most-deadly leukemia In AML, it is important to protect a patient’s remission In AML, it is important to protect a patient’s remission A patient in first AML remission wants to focus on the positive A patient in first AML remission wants to focus on the positive

aAmong 1,557 adult patients treated in the AML96 trial from 1996 to 2005. The trial protocol defined different treatment strategies for patients 18–60 years of age and for patients >60 years of age. The median age of patients was 67 years (range, 18–87 years) with roughly half older than 60. Relapse rates were ~30-35% in patients aged 18–60 with favorable risk factors, and ~70-80% in patients >60 years of age with adverse risk factors. Patients in the favorable cytogenetic risk category included: t(8;21), inv(16), and t(16;16). Patients in the adverse risk category had either 7, 5, 5q–, 7q–, t(6;9), inv(3q), t(9;22), or three cytogenetic aberrations.3
bSEER statistics. 5-year relative survival from diagnosis, 2013–2019.5
CDerived from SEER 5-year relative survival estimate, 2013–2019, for ages 65+.5 Among the 65+ population, individual survival estimates may vary.

AML, acute myeloid leukemia; SEER, Surveillance, Epidemiology, and End Results.

Understand the Factors That Can Influence Post-Remission Treatment Plans

Individualize post-remission treatment plans to help improve outcomes6,8

For most patients, AML requires lifelong treatment that should continue after remission6,8

Post-remission treatment algorithm Post-remission treatment algorithm

Some reasons a patient may not proceed to transplant:

  • Patient preference11,12
  • Performance status11,12
  • Donor quality/availability12,14,15
  • Lack of social support11,12
  • Favorable risk status13
  • Risk of non-relapse mortality14,16
  • Cost12
Prolonged post-remission survival extends the window of hope for patients with AML Prolonged post-remission survival extends the window of hope for patients with AML A patient in first AML remission wonders about treatment options other than transplant A patient in first AML remission wonders about treatment options other than transplant

For many patients

Extending overall survival while preserving quality of life is a critical factor in treatment decision-making21-24

When selecting a post-remission treatment for your patients, shared decision-making provides several potential benefits

Shared decision-making allows for greater treatment acceptance and adherence, increased understanding of benefits/risks, and improved outcomes Shared decision-making allows for greater treatment acceptance and adherence, increased understanding of benefits/risks, and improved outcomes A patient in first AML remission talks about his priorities A patient in first AML remission talks about his priorities

aComplete remission or complete remission with incomplete blood count recovery; patients may or may not receive consolidation therapy after remission.

bIn an analysis of the SEER-Medicare 2013-2015 database, 11,142 newly diagnosed adult patients with AML were evaluated and stratified into 2 groups: treatment with chemotherapy (n=4,772) and non-treatment (n=6,370). Within the treatment-with-chemotherapy group, 55.1% of patients aged 66-70 year and 26.6% of patients aged
71-75 years went on to receive HSCT.9

cONUREG (azacitidine) is indicated for continued treatment of adults with AML in first CR or CRi following intensive induction chemotherapy who are unable to complete intensive curative therapy.20
AML, acute myeloid leukemia; CR, complete remission; CRi, complete remission with incomplete blood count recovery; HSCT, hematopoietic stem cell transplantation; SEER, Surveillance, Epidemiology, and End Results.

Review the Guidelines

ONLY NCCN Category 1 preferred National Comprehensive Cancer Network® (NCCN®) maintenance treatment option across all risk categoriesa: oral azacitidine (ONUREG)25,b

Category 1 preferred treatment option in the maintenance setting: oral azacitidine (ONUREG) Category 1 preferred treatment option in the maintenance setting: oral azacitidine (ONUREG)

aIncluding patients with favorable-risk disease (other than CBF AML) and patients who completed a recommended course of consolidation.

ONUREG (azacitidine) is indicated for continued treatment of adults with AML in first CR or CRi following intensive induction chemotherapy who are unable to complete intensive curative therapy.20

bThe definition of continued and maintenance treatment by the FDA and NCCN differ based on the AML treatment period in patients with or without CR.25,26

cCategory 1 Preferred recommendation applies to patients in the maintenance setting with favorable, intermediate, or adverse risk non-CBF AML that are aged ≥55 (category 2A for other age groups) and who have received prior intensive chemotherapy and whose disease is now in remission; completed no consolidation, some consolidation or a recommended course of consolidation; and for whom no allogeneic HCT is planned.25

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia Version 2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

AML, acute myeloid leukemia; CBF, core binding factor; CR, complete remission; CRi complete remission with incomplete blood count recover; FDA, Food and Drug Administration; HCT, hematopoietic cell transplantation; NCCN, National Comprehensive Cancer Network® (NCCN®).

Meet a Patient with AML in First Remission

Denise is a patient with AML who wants to live as long as possible

Diagnosis

  • De Novo favorable-risk AMLa
  • Gene Mutation: NPM1

Baseline characteristics

  • ECOG PS: 1
  • Age: 64
  • Comorbidities: hyperlipidemia, Diabetes Mellitus type 2

Frontline therapy

  • Achieved CR after 1 induction cycle
  • Consolidation: 4 cycles planned, 2 completed
Denise wants to live as long as possible. Denise wants to live as long as possible.

What factors do you discuss when making a post-remission treatment plan with a patient like Denise?

Post-remission treatment considerations

  • Transplant-ineligible
  • Experienced infection during Cycle 2 of consolidation
  • Favorable-risk diseasea
  • Freelance copywriter nearing retiremement
  • Would like to live as long as possible to enjoy golf, gardening, and her 3 adult children

Potential questions from patients like Denise

  • What will be the quality of my life now that I am in remission?
  • Since I can't get a transplant, what are my other options?

aBased on European LeukemiaNet (ELN) cytogenetic risk stratification categories.

AML, acute myeloid leukemia; CR, complete remission; ECOG PS, Eastern Cooperative Oncology Group performance status.

Explore ONUREG Trial Results

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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