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Chapter 2 of 6

 

 

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 hear key highlights of several significant scientific updates in acute myeloid leukemia (AML) presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. Experts will share insights on a variety of abstracts covering topics including: treatment selection strategies, targeted combination therapies, immunotherapies, and novel agents for both newly diagnosed and relapsed/refractory AML patients. Don’t miss this opportunity to see how the future of treatment in AML is evolving, and how these changes may positively impact patient outcomes.

  • Chapter 1: Key Findings in AML: An Overview
  • Chapter 2: New Data from the Ongoing Phase 1 Study Evaluating Single-Agent IDH1 Inhibitor AG-120 in Relapsed/Refractory AML
  • Chapter 3: Two Phase 3 Trials in Progress: HDAC Inhibitor Pracinostat in Combination with Azacitidine; NEDD Inhibitor Pevonedistat + Aza
  • Chapter 4: Post hoc Analysis of Clinical Activity of Quizartinib in Patients with Prior TKIs
  • Chapter 5: IDH1 and IDH2 Inhibitors in Combination with Aza in the Upfront Setting
  • Chapter 6: The Role of Nivolumab in Maintenance Therapy; BCL-2 Inhibitor Studies in Newly Diagnosed AML; Impact of NGS on Therapy Selection

Target Audience

This activity is designed for multidisciplinary healthcare providers in the community setting, including hematologists, oncologists, nurses, pharmacists and other allied healthcare professionals who provide care to patients with 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 new and emerging novel therapies and treatment strategies in patients with AML
  • Describe expert faculty perspectives on key clinical trial data for novel therapies and treatment strategies in AML
  • Recognize the potential impact of clinical trials on clinical practice and existing treatment paradigms in AML

Agenda

Chapter 1: Key Findings in AML: An Overview – Naval Daver, MD

Chapter 2: New Data from the Ongoing Phase 1 Study Evaluating Single-Agent IDH1 Inhibitor AG-120 in Relapsed/Refractory AML – Eunice S. Wang, MD

  • Ivosidenib (IVO; AG-120) in mutant IDH1 relapsed/refractory acute myeloid leukemia (R/R AML): Results of a phase 1 study (7000)
  • Association of early intervention in transfusion independent (TI) patients (Pts) with lower-risk myelodysplastic syndromes (MDS) treated with attenuated doses of hypomethylating agents (HMAs) with high response rates and long duration of response (7001)

Chapter 3: Two Phase 3 Trials in Progress: HDAC Inhibitor Pracinostat in Combination with Azacitidine; NEDD Inhibitor Pevonedistat + Aza – Guillermo Garcia-Manero, MD

  • A phase 3, randomized study of pracinostat (PRAN) in combination with azacitidine (AZA) versus placebo in patients ≥18 years with newly diagnosed acute myeloid leukemia (AML) unfit for standard induction chemotherapy (IC) (TPS7078)
  • Phase 3 study of first line pevonedistat (PEV) + azacitidine (AZA) versus single-agent AZA in patients with higher-risk myelodysplastic syndromes (HR MDS), chronic myelomonocytic leukemia (CMML) or low-blast acute myelogenous leukemia (AML) (TPS7077)

Chapter 4: Post hoc Analysis of Clinical Activity of Quizartinib in Patients with Prior TKIs – Mark J. Levis, MD, PhD

  • Post hoc exploratory analysis of two phase 2 trials of quizartinib monotherapy in patients (pts) with FLT3-ITD–mutated (mu) relapsed/refractory (R/R) AML with or without prior 1st-generation FLT3 tyrosine kinase inhibitors (TKI) treatment (7017)

Chapter 5: IDH1 and IDH2 Inhibitors in Combination with Aza in the Upfront Setting – Richard Stone, MD

  • AGILE: A phase 3, multicenter, randomized, placebo-controlled study of ivosidenib in combination with azacitidine in adult patients with previously untreated acute myeloid leukemia with an IDH1 mutation (TPS7074)
  • Mutant IDH (mIDH) inhibitors, ivosidenib or enasidenib, with azacitidine (AZA) in patients with acute myeloid leukemia (AML) (7042)

Chapter 6: The Role of Nivolumab in Maintenance Therapy; BCL-2 Inhibitor Studies in Newly Diagnosed AML; Impact of NGS on Therapy Selection – Naval Daver, MD

  • Nivolumab (Nivo) maintenance (maint) in high-risk (HR) acute myeloid leukemia (AML) patients (7014)
  • Durable response with venetoclax in combination with decitabine or azacitadine in elderly patients with acute myeloid leukemia (AML) (7010)
  • Impact of next-generation sequencing (NGS) on treatment selection in acute myeloid leukemia (AML) (103)

Instructions for Participation and Credit

This activity is eligible for credit through July 31, 2019. 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.

Mark J. Levis, MD, PhD
Professor of Oncology
Director, Adult Leukemia Service
Co-Director, Division of Hematologic Malignancies
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland

Dr. Mark Levis completed a baccalaureate in genetics at UC Berkeley, and is a graduate of the Medical Scientist Training Program from UC San Francisco. He completed his residency training in internal medicine and a fellowship in medical oncology at Johns Hopkins University. He is a Professor of Oncology and the Director of the Adult Leukemia Service and Co-Director of the Division of Hematologic Malignancies at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. His broad research goals are to identify and validate novel molecular therapeutic targets in hematopoietic malignancies. His research group is interested in the identification and pre-clinical development of novel targeted therapies, and, in particular, the translational step of this research by using correlative studies to incorporate these novel therapies into existing treatments. Currently, Dr. Levis is actively involved in the pre-clinical and clinical development of small molecule kinase inhibitors targeting signaling pathway in acute myeloid leukemia, with a particular focus on FLT3.

Richard Stone, MD
Professor of Medicine
Harvard Medical School
Chief of Staff
Director, Adult Acute Leukemia Program
Dana-Farber Cancer Institute
Boston, Massachusetts

Dr. Richard Stone received his medical degree from Harvard Medical School, Boston. He completed his internal medicine residency training at Brigham and Women’s Hospital and his hematology-oncology fellowship at Dana-Farber Cancer Institute. He is the Chief of Staff and Director of the Adult Acute Leukemia Program at Dana-Farber, and Professor of Medicine at Harvard Medical School. Dr. Stone is nationally recognized for his translational and clinical research concerning blood and bone marrow malignancies including acute leukemia, myeloproliferative disorders, and myelodysplastic syndrome (a bone marrow failure state that may convert to leukemia).

In addition to his work at Dana-Farber, Dr. Stone serves as Chair of the Medical Oncology Board of the Aplastic Anemia & MDS International Foundation and Chairman of the Leukemia Core Committee for the National Cooperative Trials Group the Alliance.

Eunice S. Wang, MD
Chief, Clinical Leukemia Service
Professor, Department of Medicine
Roswell Park Comprehensive Cancer Center
Buffalo, New York

Dr. Eunice Wang earned her medical degree from the Keck (University of Southern California) School of Medicine. She completed her internship and residency in internal medicine at Yale-New Haven Hospital, followed by clinical and research fellowships in hematology-oncology at Memorial Sloan Kettering Cancer Center in New York. She is Chief of the Leukemia Service and Professor of Oncology in the Department of Medicine at Roswell Park Comprehensive Cancer Center, Buffalo, New York. She is also an Associate Professor in the Department of Medicine, School of Medicine of Biomedical Sciences at the State University of New York at Buffalo (SUNY-UB).

Dr. Wang is a member of several professional organizations including the American Society of Hematology and the American Society of Clinical Oncology. She serves on the National Comprehensive Cancer Network (NCCN) Clinical Practice treatment guidelines panels for acute myeloid and acute lymphocytic leukemia. She is a prior recipient of a NIH Cancer Clinical Investigator Team Leadership Award (CCITLA) and a Mentored Research Scholar award from the American Cancer Society. Dr. Wang has authored/co-authored more than 90 peer-reviewed articles in the field of hematological malignancies. She maintains an active clinical practice with a portfolio of early phase clinical trials in acute leukemias and myeloid malignancies. She also leads a translational laboratory focused on preclinical studies of novel agents targeting the marrow microenvironment and immune responses.

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Provided by MediCom Worldwide, Inc.

This activity is supported by educational grants from Agios Pharmaceuticals, Inc., Celgene Corporation, Daiichi Sankyo, Inc., and Helsinn Healthcare SA



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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. Mark Levis has received honoraria as a consultant from Agios, Astellas Pharma US, Inc., Daiichi Sankyo, Inc., Fujifilm Corporation, and Novartis AG. He has received grant support related to research activities from Astellas, Fujifilm, and Novartis.

Dr. Richard Stone has received honoraria as a consultant from AbbVie Inc., Agios, Amgen Inc., Arginex, Arog Pharmaceuticals, Inc., Astellas Pharma US, Inc., Celator Pharmaceuticals, Inc., Celgene Corporation, Cornerstone Therapeutics Inc., Fujifilm Corporation, Janssen Pharmaceuticals, Inc., Jazz Pharmaceuticals plc, Novartis AG, Orsenix, LLC, Otsuka Pharmaceutical Co., Ltd., and Pfizer Inc.; as well as honoraria related to formal advisory activities from Actinium Pharmaceuticals, Inc. He has received grant support related to research activities from Agios, Arog, and Novartis. He has also disclosed he is a steering committee and data safety monitoring board (DSMB) member of Celgene and board member of Actinium.

Dr. Eunice Wang has received honoraria related to formal advisory activities from AbbVie Inc., Amgen Inc., Arog Pharmaceuticals, Inc., ImmunoGen, Inc., and Pfizer Inc., as well as speakers’ bureau activities from Jazz Pharmaceuticals plc and Novartis AG.

Planning Committee Disclosures

The individuals listed below from MediCom Worldwide, Inc. reported the following for this activity: Kristin Burke, Project Manager, Keith D’Oria, Medical Writer, and Joan Meyer, RN, MHA, Executive Director, have 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.