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Chapter 4 of 5

 

 

Expected time to complete this activity as designed: 60 minutes
There are no fees for participating in or receiving credit for this online activity.

Program Overview

In this activity, participants will learn about key highlights of the latest and most impactful data in acute myeloid leukemia (AML), presented at the 2017 American Society of Hematology (ASH) Annual Meeting.

Chapter 1: Developments in FLT3 Inhibitors, Chemotherapy, and Small Molecule Inhibitors

Chapter 2: Pracinostat with Azacitidine in Elderly Patients

Chapter 3: CPX-351 vs 7+3 in Older Adults: Efficacy and Safety Reported in Clinical Trial

Chapter 4: Biomarker-driven Treatments: Ivosidenib, Enasidenib, and Sy-1425

Chapter 5: Combination Therapies Involving Gilteritinib and Venetoclax

Target Audience

This activity is designed for physicians, pharmacists, physician assistants, nurses, and other health care professionals who have an interest in enhancing their clinical skills in acute myeloid leukemia.

Learning Objectives

Upon completion of this educational activity, participants should be able to:

  • Summarize the efficacy and safety data from clinical trials investigating emerging and targeted therapies and treatment strategies in patients with acute myeloid leukemia (AML)
  • Recognize the potential impact of clinical trials on clinical practice and existing treatment paradigms in AML

Agenda

Chapter 1: Developments in FLT3 Inhibitors, Chemotherapy, and Small Molecule Inhibitors – Naval Daver, MD

  • The Combination of Quizartinib with Azacitidine or Low Dose Cytarabine Is Highly Active in Patients (Pts) with FLT3-ITD Mutated Myeloid Leukemias: Interim Report of a Phase I/II Trial (723)
  • Nivolumab (Nivo) with Azacytidine (AZA) in Patients (pts) with Relapsed Acute Myeloid Leukemia (AML) or Frontline Elderly AML (1345)
  • A Phase I/II Study of Selinexor (SEL) with Sorafenib in Patients (pts) with Relapsed and/or Refractory (R/R) FLT3 Mutated Acute Myeloid Leukemia (AML) (1344)
  • A Phase I Study of FLX925, a Dual FLT3 and CDK4/6 Inhibitor in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) (1343)

Chapter 2: Pracinostat with Azacitidine in Elderly Patients – Guillermo Garcia-Manero, MD

  • Evaluation of the Correlation between Response and Duration of Treatment in a Phase 2 Study of Pracinostat Plus Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML) (1358)

Chapter 3: CPX-351 vs 7+3 in Older Adults: Efficacy and Safety Reported in Clinical Trial – Jeffrey E. Lancet, MD

  • Efficacy and Safety of CPX-351 Versus 7+3 in Older Adults with Secondary Acute Myeloid Leukemia: Combined Subgroup Analysis of Phase 2 and Phase 3 Studies (2657)
  • Therapy-related AML and its relation to de novo AML: Impact on prognosis and treatment decisions

Chapter 4: Biomarker-driven Treatments: Ivosidenib, Enasidenib, and Sy-1425 – Eytan M. Stein, MD

  • Ivosidenib (AG-120) in Mutant IDH1 AML and Advanced Hematologic Malignancies: Results of a Phase 1 Dose Escalation and Expansion Study (725)
  • Ivosidenib or Enasidenib Combined with Standard Induction Chemotherapy Is Well Tolerated and Active in Patients with Newly Diagnosed AML with an IDH1 or IDH2 Mutation: Initial Results from a Phase 1 Trial (726)
  • Early Results from a Biomarker-Directed Phase 2 Trial of Sy-1425 in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Demonstrate DHRS3 Induction and Myeloid Differentiation Following Sy-1425 Treatment (2633)

Chapter 5: Combination Therapies Involving Gilteritinib and Venetoclax – Keith W. Pratz, MD

  • Preliminary Results from a Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML) (722)
  • Updated Safety and Efficacy of Venetoclax with Decitabine or Azacitidine in Treatment-Naive, Elderly Patients with Acute Myeloid Leukemia (2628)

Instructions for Participation and Credit

This activity is eligible for credit through December 21, 2018. After this date, this activity will expire and no further credit will be awarded.

  1. Read the target audience, learning objectives, and faculty disclosures.
  2. You may be asked to complete a short pre-test before accessing the educational content. This must be completed in order to move forward in the activity.
  3. Complete the educational content as designed.
  4. Complete the post-test. To receive a certificate, you must receive a passing score of 70%.
  5. Complete the activity evaluation survey to provide feedback and information useful for future programming.
  6. Certificates for CME and CNE may be printed immediately after successfully completing the post-test and activity evaluation. Pharmacist credit will be uploaded to CPE Monitor 4 weeks following receipt of a completed, qualified form.

Faculty Biographies

Naval Daver, MD
Assistant Professor
Department of Leukemia
The University of Texas MD Anderson Cancer Center
Houston, Texas

Dr. Naval Daver received his medical degree from Grant Medical College and Sir JJ Group of Hospitals, Mumbai, India, followed by a residency and fellowship in hematology-oncology from Baylor College of Medicine in Houston, Texas. He is an Assistant Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center.

A clinical investigator with a focus on molecular and immune therapies in acute myeloid leukemia (AML) and myelofibrosis, Dr. Daver is the co/principal investigator for more than 25 ongoing clinical trials in these diseases. These trials focus on developing a personalized therapy approach by targeting specific mutations or immune pathways expressed by patients with AML, evaluating novel combinations of targeted, immune and cytotoxic agents, and identifying and overcoming mechanism of resistance. He is especially interested in developing immune checkpoint- and vaccine-based approaches in AML, myelodysplastic syndromes (MDS), and myelofibrosis, and is conducting a number of these trials. Dr. Daver has published more than 100 peer-reviewed manuscripts. He has also authored numerous abstracts at national and international conferences.

Guillermo Garcia-Manero, MD
Professor
Chief, Section of Myelodysplastic Syndromes
Deputy Chair, Translational Research
Department of Leukemia
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, Texas

Dr. Guillermo Garcia-Manero received his medical degree from the University of Zaragoza, Spain. He completed his clinical internship, residency, and clinical fellowship in hematology and medical oncology at Thomas Jefferson University Hospital, Philadelphia. Dr. Garcia-Manero is Professor and Chief, Section of Myelodysplastic Syndromes (MDS) and Deputy Chair of Translational Research, Department of Leukemia, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center (UTMDACC) in Houston. In addition, he is Co-Director, DNA Methylation Core, and the endowed Dr. Kenneth B. McCredie Chair in Clinical Leukemia Research, Department of Leukemia, Division of Cancer Medicine, at UTMDACC.

Dr. Garcia-Manero is board certified in medical oncology (hematology eligible), and internal medicine. He holds membership in the American Association for the Advancement of Science, American Society of Hematology, American Society of Clinical Oncology, American Association of Cancer Research (Chair, Scientific Review Committee), Aplastic Anemia and International Myelodysplastic Syndromes Foundation (Steering Committee/Medical Advisory Board), American Medical Association (AMA) Foundation, Society of Hematologic Oncology, and the European Hematology Association. In addition, he is an editor/journal reviewer for numerous peer-reviewed publications. Dr. Garcia-Manero has written more than 800 abstracts, invited articles, and editorials in scientific journals, and is the Principal Investigator in several MDS studies.

Jeffrey E. Lancet, MD
Department Chair
Malignant Hematology
Moffitt Cancer Center
Tampa, Florida

Dr. Jeffrey Lancet is a hematologist at Moffitt Cancer Center and the Department Chair of Malignant Hematology. He focuses his clinical practice in acute leukemias and myelodysplastic syndromes. He also provides consultation for other hematologic malignancies. As a clinical investigator, Dr. Lancet has written, authored and published several early phase clinical trials utilizing novel therapies for these diseases, and currently serves as the principal investigator for many ongoing trials. Within the field of acute leukemias, he has worked extensively with the National Cancer Institute, the Southwest Oncology Group, and the pharmaceutical industry. Dr. Lancet was a recipient of the NCI-ASCO Clinical Investigator Team Leadership Award in 2010.

Keith W. Pratz, MD
Assistant Professor of Oncology
Sidney Kimmel Comprehensive Cancer Center
Johns Hopkins University
Baltimore, Maryland

Dr. Keith Pratz received his medical degree from UMDNJ Robert Wood Johnson Medical School, Camden, New Jersey. He completed his residency in internal medicine at Mayo Graduate School of Medicine, Rochester, Minnesota, and his fellowship in medical oncology at The Johns Hopkins Hospital, Baltimore, Maryland. Dr. Pratz is a clinical investigator of novel therapeutics for acute leukemias and is an Assistant Professor of Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. He is the principal investigator on clinical trials incorporating novel targeted therapies into combination chemotherapy in acute leukemia. Dr. Pratz is also active in designing, coordinating, and conducting laboratory correlative studies in the setting of investigational therapies to aid in the development of improved treatments for hematologic malignancies.

Eytan M. Stein, MD
Assistant Professor
Leukemia Service
Memorial Sloan Kettering Cancer Center
New York, New York

Dr. Eytan Stein received his medical degree from Northwestern University in Chicago, where he also completed his internal medicine residency. He then completed his fellowships in medicine at Weill Cornell Medical College, and in medical oncology and hematology at Memorial Sloan Kettering. He is an Assistant Professor on the Leukemia Service at Memorial Sloan Kettering Cancer Center in New York City.

Dr. Stein holds board certification from the American Board of Internal Medicine, American Board of Clinical Oncology, and the American Board of Hematology. He focuses his practice on the treatment of acute and chronic leukemias, myelodysplastic syndromes, and myeloproliferative neoplasms. His research interests include developing novel, early phase clinical trials of compounds that target the genetic and epigenetic basis of myeloid malignancies.

If you have any questions or concerns regarding this activity, please contact MediCom Worldwide, Inc. at 1-800-408-4242 or email us at lisa@medicaled.com.

Provided by MediCom Worldwide, Inc.

This activity is supported by educational grants from Agios Pharmaceuticals, Celgene Corporation, Helsinn Healthcare SA, Incyte Corporation, Jazz Pharmaceuticals, Inc., and Novartis Pharmaceuticals.



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MediCom CME CREDIT
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ACPE CPE CREDIT
MediCom Worldwide, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity is acceptable for 1.0 contact hour of Continuing Education Credit. Universal Activity Number: 827-0000-17-181-H01-P. Knowledge-based CPE activity.

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Accreditation Statement: MediCom Worldwide, Inc., 101 Washington Street, Morrisville, PA 19067 is approved by the California Board of Registered Nursing, Provider Number CEP11380. MediCom designates this CNE activity for 1.0 contact hour. Program Number: 17-181-070

Disclosure

As an organization accredited by the Accreditation Council for Continuing Medical Education (ACCME), Accreditation Council for Pharmacy Education (ACPE) and California State Board of Registered Nursing, MediCom Worldwide, Inc. requires everyone who is in a position to control the content of an educational activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines “relevant financial relationships” as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest. Accordingly, the following disclosures were made.

Faculty Disclosures

Dr. Naval Daver has received honoraria related to formal advisory activities from Incyte Corporation, Karyopharm Therapeutics, Otsuka Pharmaceutical Co., Ltd., and Novartis AG; as well as consultant fees from Bristol-Myers Squibb Company, ImmunoGen, Inc., Incyte, Jazz Pharmaceuticals plc, Novartis AG, Pfizer Inc., and Sunesis Pharmaceuticals, Inc. He has received grant support related to research activities from Bristol-Myers Squibb, Daiichi Sankyo, Inc., ImmunoGen, Incyte, Karyopharm, Pfizer, SERVIER, and Sunesis.

Dr. Guillermo Garcia-Manero has disclosed no relevant financial relationships.

Dr. Jeffrey Lancet has received honoraria as a consultant from Astellas Pharma US, Inc., Celgene Corporation, Janssen Pharmaceuticals, Inc., and Jazz Pharmaceuticals plc, as well as formal advisory activities from Astellas and BioSight Ltd.

Dr. Keith Pratz has received grant support related to research activities from AbbVie Inc., Agios, Astellas Pharma US, Inc., and Millennium Pharmaceuticals, Inc.

Dr. Eytan Stein has received honoraria related to formal advisory activities from Agios and Celgene Corporation.

Planning Committee Disclosures

The individual listed below from MediCom Worldwide, Inc. reported the following for this activity: Joan Meyer, RN, MHA, Executive Director, has no relevant financial relationships.

Peer Reviewer Disclosure

In accordance with MediCom Worldwide, Inc. policy, all content is reviewed by external independent peer reviewers for balance, objectivity and commercial bias. The peer reviewers have no relevant financial relationships to disclose.