Current Management Paradigms in Acute Myeloid Leukemia — A Second Opinion Case Review

Join us on Friday, December 11^th from 7:30 AM to 9:30 AM central time (8:30 AM to 10:30 AM eastern time).

Module 1: Nontargeted Treatment for Newly Diagnosed and Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

• Long-term data with and optimal integration of venetoclax-based combination therapy for patients with newly diagnosed AML who are older or ineligible for intensive induction chemotherapy
• Available findings, including those from the PARADIGM study, with venetoclax-based regimens for younger, fit patients with newly diagnosed AML; current role outside of a research setting
• Activity, tolerability and current role, if any, of venetoclax-based regimens for patients with R/R AML
• Key efficacy and safety data from the ASCERTAIN-V trial evaluating the all-oral regimen of decitabine/cedazuridine with venetoclax for patients with AML who are ineligible for intensive induction chemotherapy
• Recent FDA approval of oral decitabine/cedazuridine in combination with venetoclax for patients with newly diagnosed AML who are ineligible for intensive induction chemotherapy; potential role of decitabine/cedazuridine alongside standard hypomethylating agents (HMAs), including as a component of all-oral up-front therapy

Module 2: Role of FLT3 Inhibition in AML Management

• Pharmacologic similarities and differences among available FLT3 inhibitors for AML; potency, activity and tolerability
• Principal findings from the Phase III QuANTUM-First study evaluating the addition of quizartinib to chemotherapy and continued as a single agent for patients with newly diagnosed FLT3-ITD-positive AML; current clinical role
• Rationale for the ongoing Phase III QuANTUM-Wild trial evaluating quizartinib in combination with standard intensive induction and consolidation chemotherapy followed by single-agent quizartinib maintenance therapy for FLT3-ITD-negative AML
• Long-term outcomes reported with gilteritinib versus salvage chemotherapy for patients with R/R AML with a FLT3 mutation; optimal incorporation of gilteritinib in this clinical setting
• Major efficacy and safety data from the Phase III MORPHO study of gilteritinib as post-transplant maintenance therapy for AML with a FLT3-ITD mutation; implications of minimal residual disease positivity for outcomes and potential clinical role of this strategy
• Early data combining quizartinib or gilteritinib with venetoclax/HMA as up-front therapy; ongoing Phase III VENP-A-QUI study evaluating quizartinib with venetoclax/azacitidine for older or less fit patients with newly diagnosed FLT3-ITD-negative and FLT3-ITD-positive AML

Module 3: IDH1/2-Targeted Therapy for AML

• Mechanistic similarities and differences between available IDH1 inhibitors, such as ivosidenib and olutasidenib, and IDH2 inhibitors, such as enasidenib
• Optimal integration of ivosidenib into the current management paradigm for patients with newly diagnosed and R/R IDH1-mutant AML
• Major efficacy and safety findings with olutasidenib for R/R AML with an IDH1 mutation
• FDA approval of olutasidenib and optimal integration into current management algorithms
• Ongoing research efforts assessing ivosidenib and olutasidenib as a component of up-front therapy
• Long-term findings supporting the use of enasidenib for R/R IDH2-mutant AML; early data with its use as a component of up-front combination therapy

Module 4: Current and Future Use of Menin Inhibitors for AML

• Mechanism of action of menin inhibitors; pharmacologic similarities and differences between approved (revumenib, ziftomenib) and investigational (eg, bleximenib, enzomenib) agents
• Published efficacy and safety data with revumenib for patients with R/R KMT2A-rearranged acute leukemias and NPM1-mutant AML in the Phase I/II AUGMENT-101 trial
• Key efficacy and safety findings from the Phase I/II KOMET-001 trial evaluating ziftomenib for R/R NPM1-mutant AML
• FDA approvals of revumenib for patients with R/R acute leukemias with a KMT2A translocation and of revumenib and ziftomenib for those with R/R AML with NPM1 mutations; appropriate integration into the treatment paradigm
• Available data with and ongoing investigation of bleximenib and enzomenib for patients with AML
• Biological rationale for, early research findings with and ongoing clinical trials of menin inhibitors in combination with other AML therapies
• Spectrum, incidence and severity of side effects, including differentiation syndrome and cardiac toxicity, with menin inhibitors; appropriate monitoring and management protocols

Module 5: Other Novel Agents and Strategies Under Investigation for AML

• Rationale for targeting CD123 in AML; incidence and clinical implications of CD123 overexpression
• Structural components and mechanism of action of the CD123-targeted antibody-drug conjugate pivekimab sunirine; rationale for combining it with other systemic regimens for AML
• Available early-phase research findings with pivekimab sunirine as monotherapy and in combination with venetoclax/HMA or intensive chemotherapy for patients with R/R and newly diagnosed AML; ongoing studies and potential clinical role
• Mechanism of action of, available efficacy and safety data with and future development plans for the CD123-directed cytotoxin tagraxofusp for patients with AML
• Recent FDA approval of Orca-T® for matched-donor hematopoietic stem cell transplant; other promising investigational agents and strategies, such as IPN60340, CLN-049 and sonrotoclax, for patients with AML

Target Audience
This activity is intended for hematologists, medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of acute myeloid leukemia (AML).

Learning Objectives
At the conclusion of this activity, participants should be able to

• Analyze patient-specific factors and available clinical trial data guiding the selection of induction therapy for individuals with primary and secondary AML to optimize clinical and quality-of-life outcomes. 
• Evaluate the biological rationale for and available research findings with Bcl-2-targeted therapy for individuals with AML, and appraise the current role of this strategy. 
• Assess the scientific justification for and published research findings with oral hypomethylating agent therapy for AML to determine the appropriate clinical application of this approach. 
• Reflect on available research evidence with approved FLT3 inhibitors, and use this information to guide the clinical management of newly diagnosed or progressive AML harboring a FLT3 mutation. 
• Understand available efficacy and safety data with IDH1 inhibitors for patients with IDH1 mutation-positive AML, and integrate this novel approach into current treatment algorithms. 
• Recognize the scientific justification for the development of menin inhibitors for the treatment of certain genetically defined subsets of AML, and consider available research findings with and the current and potential role of these novel agents. 
• Review the biological rationale for, published efficacy and safety data with and ongoing evaluation of CD123-targeted therapy for individuals with AML, and consider the future role of these agents. 
• Understand the spectrum, incidence and severity of side effects associated with targeted therapies employed in AML management, and develop appropriate monitoring and management protocols. 
• Recall new data with novel agents and strategies currently under investigation for AML, and discuss ongoing trial opportunities with eligible patients.  

CE Credit
CME credit information will be provided to each participant at the conclusion of the activity.

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Credit Designation Statement
Research To Practice designates this live activity for a maximum of 2 AMA PRA Category 1 Credits^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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Unlabeled/Unapproved Uses Notice
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the provider or grantors.

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Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships will have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. Faculty disclosures to be announced.

FACULTY — Prof de Botton has no relevant financial relationships to disclose. The following faculty reported relevant financial relationships with ineligible entities:

Dr DiNardo — Advisory Committees: Astellas, Daiichi Sankyo Inc, Kura Oncology, Pfizer Inc, Syndax Pharmaceuticals, SystImmune Inc; Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Rigel Pharmaceuticals Inc, Ryvu Therapeutics, Servier Pharmaceuticals LLC, Solu Therapeutics; Contracted Research: AbbVie Inc, Auron Therapeutics, Bristol Myers Squibb, PMV Pharmaceuticals, Remix Therapeutics, Rigel Pharmaceuticals Inc, Servier Pharmaceuticals LLC, SystImmune Inc; Data and Safety Monitoring Boards/Committees: Genmab US Inc. Dr Erba — Consulting Agreements: Daiichi Sankyo Inc, Geron Corporation, Kura Oncology, Rigel Pharmaceuticals Inc, Servier Pharmaceuticals LLC, Sumitomo Pharma America, Taiho Oncology Inc; Contracted Research: Agios Pharmaceuticals Inc, Aptose Biosciences Inc, Ascentage Pharma, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Kura Oncology, Oryzon, Rigel Pharmaceuticals Inc, Sumitomo Pharma America, Taiho Oncology Inc; Speakers Bureaus: Daiichi Sankyo Inc, Incyte Corporation, Kura Oncology, Servier Pharmaceuticals LLC, Syndax Pharmaceuticals; Steering Committees: Daiichi Sankyo Inc (co-chair). Prof Wei — Advisory Committees: AbbVie Inc, Aculeus Therapeutics, Astellas, BeOne, Bristol Myers Squibb, Geron Corporation, Johnson & Johnson, Molecular Partners, Pfizer Inc, Servier Pharmaceuticals LLC, Syndax Pharmaceuticals; Consulting Agreements: Cycuria Therapeutics, Johnson & Johnson, Servier Pharmaceuticals LLC; Contracted Research: AbbVie Inc, Astellas, AstraZeneca Pharmaceuticals LP, Dimericon Therapeutics, Johnson & Johnson, Mendus, PharmaEngine Inc, Servier Pharmaceuticals LLC, Syndax Pharmaceuticals; Financial Benefits via Institution: The Walter and Eliza Hall Institute (WEHI) receives milestone and royalty payments related to the development of venetoclax. Current and past employees of WEHI may be eligible for financial benefits related to these payments. Prof Wei is an employee of WEHI and receives such a financial benefit; Speakers Bureaus: AbbVie Inc, Astellas.

MODERATOR
Dr Fathi — Consulting Agreements: AbbVie Inc, Astellas, AstraZeneca Pharmaceuticals LP, Autolus, Azurity Pharmaceuticals, BeOne, Bristol Myers Squibb, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Genmab US Inc, Johnson & Johnson, Kura Oncology, Novartis, Pfizer Inc, Servier Pharmaceuticals LLC, Syndax Pharmaceuticals, Takeda Pharmaceuticals USA Inc, Thermo Fisher Scientific; Contracted Research: AbbVie Inc, Bristol Myers Squibb, Genentech, a member of the Roche Group, Kura Oncology, Servier Pharmaceuticals LLC.

Research To Practice CME Planning Committee Members, Staff and Reviewers
Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

Supporters
This activity is supported by educational grants from AbbVie Inc, Astellas, Daiichi Sankyo Inc, Kura Oncology, Rigel Pharmaceuticals Inc, Sumitomo Pharma America, and Taiho Oncology Inc.

Sheraton New Orleans Hotel
500 Canal Street
New Orleans, LA 70130
Hotel Phone: (504) 525-2500

Meeting Room
Napoleon Ballroom A/B — Third floor

Directions
The Sheraton New Orleans Hotel is located 0.9 miles (15-minute walk) from the New Orleans Ernest N Morial Convention Center, where the 2026 ASH Annual Meeting is taking place.

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