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Friday, December 6, 2019, Orlando, Florida, 7:00 AM – 9:30 AM

Data + Perspectives: Exploring the Role of Novel Agents and Emerging Strategies in the Management of Acute Myeloid Leukemia

A Friday Satellite Symposium Preceding the 61st ASH Annual Meeting

This live activity will blend together two distinct content elements — review of important data sets and discussion of actual cases — to focus on one of the most rapidly evolving areas in all of cancer medicine – the role of novel agents and strategies in the management of acute myeloid leukemia (AML). Each of the activity's four modules will contain a case-based discussion and corresponding faculty presentation and center on a specific topic related to the integration of novel agents into the care of patients with AML. To cultivate a more interactive experience, clinicians in attendance at each event will utilize networked iPads® to complete an onsite survey featuring a number of the same questions and topics to be discussed, the results of which will be presented and discussed throughout the program.

Event Details

Location
Hilton Orlando
6001 Destination Parkway
Orlando, FL 32819
Hotel Phone: (407) 313-4300

Time
7:00 AM – 7:30 AM — Registration and Breakfast Buffet
7:30 AM – 9:30 AM — Educational Meeting

Meeting Room
Orange Ballroom (Lower Level)

There is no registration fee for this event. However, preregistration is advised as seating is limited.  
 
Faculty
Mark Levis, MD, PhD
Director, Adult Leukemia Program
Co-Division Director, Hematologic Malignancies
Professor of Oncology
The Sidney Kimmel Comprehensive Cancer Center
Johns Hopkins Medicine
Baltimore, Maryland

Daniel A Pollyea, MD, MS
Associate Professor of Medicine
Clinical Director of Leukemia Services
Robert H Allen, MD Chair in Hematology Research
Division of Hematology
University of Colorado School of Medicine
Aurora, Colorado


Richard M Stone, MD
Director, Translational Research
Leukemia Division
Dana-Farber Cancer Institute
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Andrew H Wei, MBBS, PhD
Adjunct Associate Professor
Department of Haematology
Alfred Hospital
Melbourne, Australia

Moderator:
Neil Love, MD
Research To Practice
Miami, Florida



Agenda

Event Time
7:00 AM – 7:30 AM — Registration and Breakfast Buffet
7:30 AM – 9:30 AM — Educational Meeting

MODULE 1: Evolving Paradigms in Up-Front Treatment for Older Patients or Those Ineligible for Intensive Chemotherapy — Dr Pollyea

  • Biologic rationale for targeting Bcl-2 in patients with acute myeloid leukemia (AML)
  • Published efficacy and safety data supporting the recent FDA approval of venetoclax in combination with azacitidine, decitabine or low-dose cytarabine for patients with newly diagnosed AML who are not candidates for intensive induction chemotherapy
  • Dose and schedule of venetoclax when used in combination with a hypomethylating agent or low-dose cytarabine for AML
  • Incidence of tumor lysis syndrome (TLS) and other adverse events (AEs) associated with the use of venetoclax in AML clinical trials; implications for the implementation of TLS prophylactic measures in routine practice
  • Proposed role of the hedgehog pathway in AML pathogenesis
  • Design, entry criteria and key efficacy and safety findings from the Phase II BRIGHT 1003 trial of glasdegib in combination with low-dose cytarabine for newly diagnosed AML in older patients or those who are unable to receive intensive induction chemotherapy; recent FDA approval of glasdegib and integration into current care

MODULE 2: Assessment, Incidence and Clinical Significance of FLT3 Mutations in AML — Dr Stone

  • Spectrum of genomic abnormalities observed in patients with AML and current indications for molecular testing
  • Incidence and prognostic and/or predictive relevance of various FLT3 mutations (eg, FLT3-ITD with high allelic ratio, FLT3-ITD with low allelic ratio, FLT3-TKD)
  • Clinical database underlying the FDA approval of midostaurin for fit patients with newly diagnosed AML and a FLT3 mutation; patient selection and optimal incorporation into current management
  • Available research data with gilteritinib for FLT3 mutation-positive AML; recent FDA approval of gilteritinib for relapsed/refractory disease and appropriate integration into routine practice
  • Efficacy and safety findings from the Phase III QuANTUM-R study of quizartinib versus salvage chemotherapy for patients with relapsed/refractory AML and a FLT3 mutation; recent FDA decision to decline approval and implications for future development plans
  • Ongoing clinical trials of approved and investigational agents for patients with newly diagnosed and progressive AML with FLT3 mutations

MODULE 3: Long-Term Treatment for Patients with AML with IDH Mutations — Dr Levis

  • Frequency of IDH1 and IDH2 mutations in patients with newly diagnosed and previously treated AML
  • Published research database supporting the FDA approvals of enasidenib and ivosidenib
  • Recognition and management of common and less frequently occurring AEs observed with the use of enasidenib and ivosidenib
  • Incidence, presentation and management of differentiation syndrome with enasidenib and ivosidenib
  • Early activity and safety with the use of enasidenib or ivosidenib in combination with chemotherapy for patients with newly diagnosed AML and an IDH mutation; future development plans
  • Other IDH inhibitors in clinical development (eg, vorasidenib, olutasidenib)

MODULE 4: Other Novel Agents and Promising Strategies Under Evaluation for Patients with AML — Prof Wei

  • Biologic rationale for targeting CD33 in AML; meta-analysis of randomized trials of gemtuzumab ozogamicin in combination with standard induction chemotherapy demonstrating an overall survival benefit with its use in individuals without adverse cytogenetics
  • FDA “reapproval” and current clinical role of gemtuzumab ozogamicin
  • Emerging data from the Phase III QUAZAR AML-001 study of CC-486 as maintenance therapy in patients with newly diagnosed AML who achieved a complete response to induction chemotherapy
  • Early activity and safety data associated with the use of novel immunotherapeutic approaches (eg, immune checkpoint inhibitors, chimeric antigen receptor T-cell therapy) in patients with AML
  • Available data with and ongoing evaluation of other promising agents in AML

CE Information

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:

  • Recognize the clinical and prognostic significance of specific cytogenetic and molecular abnormalities, and use this information to develop, adapt or refine current diagnostic testing algorithms for patients with AML.
  • Analyze how age, performance status and other biologic and disease-related factors affect the selection and sequencing of therapy for patients with various presentations of AML.
  • Assess available research evidence with approved and emerging FLT3 inhibitors, and use this information to guide clinical care and protocol opportunities for patients with newly diagnosed or progressive AML harboring a FLT3 mutation.
  • Develop an understanding of the mechanism of action, available data and current clinical role of available IDH1/2 inhibitors for patients with relapsed/refractory AML and an IDH1 or IDH2 mutation.
  • Evaluate the recent FDA approvals of novel agents targeting Bcl-2 and the hedgehog signaling pathway for patients with newly diagnosed AML ineligible for intensive therapy, and discern how these therapies can be optimally integrated into nonresearch care algorithms.
  • Design and implement a plan of care to prevent, recognize and manage side effects and toxicities associated with recently approved systemic therapies for AML to support quality of life and continuation of treatment.
  • Identify the mechanisms of action and recall new data with investigational agents demonstrating promising activity in AML, and refer appropriate patients for participation in ongoing trials evaluating these approaches.

CME Credit Form
A CME credit form will be given to each participant at the conclusion 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 2 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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. Financial disclosures will be provided in meeting course materials.

Supporters
This activity is supported by educational grants from AbbVie Inc, Agios Pharmaceuticals Inc, Astellas, Celgene Corporation, Daiichi Sankyo Inc and Genentech.

Location

Hilton Orlando
6001 Destination Parkway
Orlando, FL 32819
Hotel Phone: (407) 313-4300

Meeting Room
Orange Ballroom (Lower Level)

Directions
The Hilton Orlando hotel is conveniently located within walking distance of the Orange County Convention Center, where the ASH Annual Meeting is taking place.

 

Registration

Thank you for your interest in our CME program. At this time online preregistration is closed for this event. SEATS ARE STILL AVAILABLE FOR THE SESSION. If you are interested in attending, please visit our onsite registration desk, which will open at 6:45 AM on Friday, December 6. Our onsite registration desk will be located outside the Orange Ballroom (Lower Level) of the Hilton Orlando hotel (6001 Destination Parkway), which is adjacent to the Orlando Convention Center, where the ASH Annual Meeting is taking place.

We will accept onsite registration until reaching the meeting room capacity.
Please note, onsite registration does not guarantee participation in the session or meal service, and seating will be prioritized for clinicians in practice.

If you have any questions, please feel free to contact us via email at Meetings@ResearchToPractice.com, or call (800) 233-6153 or +1 (305) 377-2828.

NOTICE:
This educational session has been approved by ASH as part of the Friday Satellite Symposia educational schedule, and registration for this event is independent of registration for the ASH Annual Meeting