Wednesday, July 14, 2021, 5:00 PM – 6:00 PM Eastern Time (ET)

A Conversation with the Investigators: Acute Myeloid Leukemia and Myelodysplastic Syndromes

A Live CME/MOC Webinar Held Adjunct to the 2021 ASCO Annual Meeting

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Register for this complimentary event with the “Register Now” button above,
which will take you to our Zoom registration page.


Join us on Wednesday, July 14th for this CME/MOC-accredited webinar
5:00 PM – 6:00 PM ET

Faculty

Courtney D DiNardo, MD, MSCE
Associate Professor, Department of Leukemia
Division of Cancer Medicine
The University of Texas
MD Anderson Cancer Center
Houston, Texas

Gail J Roboz, MD
Director, Clinical and Translational Leukemia Programs
Professor of Medicine
Weill Cornell Medical College
NewYork-Presbyterian
New York, New York

Eytan M Stein, MD
Assistant Attending Physician
Director, Program for Drug Development in Leukemia
Leukemia Service, Department of Medicine
Memorial Sloan Kettering Cancer Center
New York, New York

Moderator
Neil Love, MD
Research To Practice
Miami, Florida


Not an official event of the 2021 ASCO Annual Meeting. Not sponsored, endorsed, or accredited by ASCO®, CancerLinQ®, or Conquer Cancer® the ASCO Foundation.

This activity is supported by educational grants from AbbVie Inc, Genentech, a member of the Roche Group, Jazz Pharmaceuticals Inc and Taiho Oncology Inc.

Management of Acute Myeloid Leukemia (AML) in Older Patients or Those Ineligible for Intensive Chemotherapy

  • Published data supporting the FDA approval of venetoclax in combination with azacitidine, decitabine or low-dose cytarabine (LDC) for patients with newly diagnosed AML aged 75 or older or those who are not candidates for intensive induction chemotherapy
  • Design, eligibility criteria and key efficacy and safety findings from the Phase III VIALE-A and VIALE-C trials evaluating venetoclax in combination with azacitidine or LDC, respectively, as first-line treatment for patients with AML who are ineligible for intensive chemotherapy
  • Incidence of tumor lysis syndrome and other adverse events associated with venetoclax in AML clinical trials; implications for the implementation of prophylactic measures in routine practice

Treatment Options for Patients with AML Harboring FLT3 Mutations

  • Clinical trial database underlying the FDA approval of midostaurin and optimal incorporation of this agent into current AML management
  • Design, eligibility criteria and key efficacy and safety outcomes of the Phase III ADMIRAL trial comparing gilteritinib to salvage chemotherapy for patients with relapsed/refractory AML and FLT3 mutations; FDA-approved indication for gilteritinib and appropriate integration into routine practice
  • Available data with gilteritinib combined with standard induction/consolidation chemotherapy for newly diagnosed AML; ongoing investigations of gilteritinib in the front-line setting
  • Recognition and management of common and less frequent adverse events observed with midostaurin and with gilteritinib therapy

Management of AML with IDH Mutations

  • Efficacy and safety findings leading to the FDA approval of ivosidenib for patients with newly diagnosed AML with IDH1 mutations who are at least 75 years old or have comorbidities that preclude intensive induction chemotherapy
  • Long-term follow-up data supporting the FDA approvals of ivosidenib and enasidenib for relapsed/refractory AML
  • Activity and safety of enasidenib as monotherapy and in combination with chemotherapy for patients with newly diagnosed AML and an IDH2 mutation
  • Incidence, presentation and management of differentiation syndrome and other adverse events with IDH inhibitors
  • Efficacy and tolerability of venetoclax-based therapies in patients with targetable mutations; ongoing evaluation of venetoclax-based regimens in combination with IDH or FLT3 inhibitors

Tailoring Induction and Maintenance Therapy for Younger Patients with AML without Targetable Tumor Mutations

  • Historical outcomes with intensive induction chemotherapy for patients with AML and unfavorable prognostic features (eg, complex karyotype, TP53 mutation)
  • Ongoing investigation of venetoclax for younger, fit patients with newly diagnosed AML; current off-protocol role for high-risk disease
  • Rationale for the investigation of CC-486 as maintenance therapy for patients with AML who have responded to intensive induction chemotherapy but not undergone transplant; pharmacologic differences between CC-486 and injectable azacitidine
  • Design, entry criteria and key efficacy and safety outcomes of the Phase III QUAZAR AML-001 study assessing CC-486 as maintenance therapy
  • Recent FDA approval of CC-486; implications for routine practice and future research

Treatment of AML Secondary to Myelodysplastic Syndromes (MDS) Transformation

  • Historical outcomes with intensive induction chemotherapy for secondary AML; considerations in therapeutic decision-making for patients (age, gender, cytogenetic risk factors, treatment history)
  • Mechanism of action of CPX-351; rationale for its increased activity in patients with secondary AML
  • Long-term efficacy and safety observed with CPX-351 in the pivotal Phase III trial comparing that agent to standard 7 + 3 for newly diagnosed secondary AML; optimal integration into practice
  • Published efficacy findings with and ongoing and planned clinical trials evaluating CPX-351 in the treatment of primary AML or in combination with other agents

Management Strategies for MDS

  • Design, eligibility criteria and key endpoints of the ASTX727-01-B and ASTX727-02 (ASCERTAIN) studies evaluating the oral combination of decitabine and cedazuridine for patients with MDS
  • Response rates, duration of response and rates of transfusion independence achieved with oral decitabine/cedazuridine; FDA approval and current clinical role opposite standard IV decitabine
  • Key efficacy and safety endpoints achieved in the randomized Phase III MEDALIST trial leading to the FDA approval of luspatercept for the management of MDS-associated anemia; optimal patient selection for and timing of therapy
  • Activity observed with approved AML therapies (eg, venetoclax, ivosidenib, enasidenib, CC-486) in patients with MDS; current off-protocol role
  • Magrolimab for MDS: Mechanism of action, available data, FDA breakthrough therapy designation and potential clinical role; activity in patients with AML
  • Biologic rationale for the investigation of pevonedistat in combination with azacitidine for patients with higher-risk MDS; FDA breakthrough therapy designation for pevonedistat, ongoing evaluation and potential clinical role

Target Audience
This program is intended for medical oncologists, hematology-oncology fellows and other allied healthcare professionals involved in the treatment of acute myeloid leukemia and myelodysplastic syndromes.

Learning Objectives

  • Evaluate the importance of age, performance status and other biologic and disease-related factors in the selection and sequencing of therapy for patients with various presentations of acute myeloid leukemia (AML).
  • Appreciate the FDA approval of venetoclax in combination with azacitidine, decitabine or low-dose cytarabine for patients with newly diagnosed AML not eligible for intensive therapy, and identify individuals appropriate for treatment with this novel agent.
  • Review Phase III data documenting the efficacy of CC-486 as maintenance therapy for patients with newly diagnosed AML who achieved first complete response or complete response with incomplete blood count recovery with induction chemotherapy, and consider how this novel strategy can be applied in current clinical management.
  • Reflect on available research evidence with approved and emerging FLT3 inhibitors, and use this information to guide clinical care and protocol opportunities for appropriate patients with newly diagnosed or progressive AML harboring a FLT3 mutation.
  • Develop an understanding of the mechanisms of action of, available data with and current role for available IDH1/2 inhibitors for patients with newly diagnosed or relapsed/refractory AML and an IDH1 or 2 mutation.
  • Assess the FDA-approved indications for CPX-351 for patients with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes, and discern how this agent can be safely and optimally integrated into nonresearch care algorithms.
  • Formulate a treatment algorithm for patients with lower- and higher-risk myelodysplastic syndromes (MDS), considering patient- and disease-related factors, including cytogenetic abnormalities.
  • Recognize the recent FDA approval of the combination of decitabine and cedazuridine for intermediate- and high-risk MDS, and identify patients for whom treatment with this novel approach may be appropriate.
  • Describe the biologic rationale for and mechanism of action of luspatercept in the treatment of anemia secondary to MDS, and appraise how this agent can be appropriately integrated into clinical practice.
  • Recall promising agents and combination strategies under investigation for AML and MDS, and counsel appropriately selected patients regarding clinical trial enrollment.

CME Credit Form
CME and ABIM MOC credit form links will be emailed to each participant within 5 days of the activity.

Accreditation Statement
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

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

American Board of Internal Medicine (ABIM) — Maintenance of Certification (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1 Medical Knowledge MOC point in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information. For those clinicians wishing to receive ABIM MOC credit for attending, you will receive an email after the event with instructions.

Disclosure Policy
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the 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 provided.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS
Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

Supporters
This activity is supported by educational grants from AbbVie Inc, Genentech, a member of the Roche Group, Jazz Pharmaceuticals Inc and Taiho Oncology Inc.