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Acknowledgment of Commercial Support
This activity is supported by educational grants from AbbVie, Inc; Jazz Pharmaceuticals, Inc; and Takeda Oncology.
Community Practice Connections™: Show Me the Data™: Leveraging Evidence to Optimize Applications of Novel Therapies in AML
Release Date: August 30, 2019
Expiration Date: August 30, 2020
Media: Internet - based
Recent years have marked a period of rapid growth in AML therapeutics, with several new medications approved in 2017 and 2018. In this innovative online program chaired by Naval G. Daver, MD, and joined by Harry P. Erba, MD, PhD; Amir T. Fathi, MD; and Tapan M. Kadia, MD, experts discuss best practices in implementing new therapies across lines of care. Understanding the mechanistic characteristics of novel targeted therapies and reformulated liposomal chemotherapy is crucial to optimizing care of patients with AML in 2019. Now more than ever, understanding the state of the art in risk stratification, treatment, efficacy data, and adverse event management in an era of constant change in AML has the potential to improve clinical outcomes for patients. This program is an opportunity to learn the crucial updates and hear expert perspectives directly from top faculty and trialists.
Benefits of Participating
- Learn the latest best practices in AML directly from top experts in the field, including best practices for mutational and cytogenetic analysis of each patient
- Evaluate efficacy data and current practice patterns with use of treatments across AML
- Contextualize the appropriate setting for use of multiple therapies across the spectrum of AML and throughout the course of disease
- See the latest data in AML with regard to minimal residual disease assessment and evaluate how this upcoming risk stratification strategy may be useful in practice
- Recognize opportunities for clinical trial enrollment in specific patient types
Acknowledgement of Commercial Support
This activity is supported by educational grants from AbbVie, Inc; Jazz Pharmaceuticals, Inc; and Takeda Oncology.
Instructions for This Activity and Receiving Credit
This educational program is directed toward medical oncologists and hematologists interested in the treatment of AML. Nurse practitioners, physician assistants, nurses, and other healthcare professionals involved in the treatment and management of patients with AML will be invited to participate.
Upon successful completion of this educational activity, you should be better prepared to:
- Identify latest best practices for testing strategies and risk stratification for patients with AML.
- Describe safety and efficacy data from the latest clinical trials with recently approved and emerging treatment options across the continuum of care in AML.
- Integrate optimized treatment approaches for AML, including treatment strategies indicated for elderly patients with AML.
- Define strategies for proactive identification and management of treatment-related toxicities for patients with AML.
Faculty, Staff, and Planners’ Disclosures
Department of Leukemia
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Disclosures: Grant Research Support: AbbVie, Bristol-Myers Squibb, Daiichi Sankyo, Genentech, GlycoMimetics, ImmunoGen, Incyte, Karyopharm, Nohla Therapeutics, Novartis, Pfizer, Sunesis, Servier; Consultant: AbbVie, Agios, Astellas, Bristol-Myers Squibb, Celgene, Daiichi Sankyo, ImmunoGen, Incyte, Jazz Pharmaceuticals, Karyopharm, Novartis, Otsuka, Pfizer, Sunesis; Other: Honoraria: AbbVie, Astellas, Bristol-Myers Squibb, ImmunoGen, Incyte, Jazz Pharmaceuticals, Novartis, Otsuka, Pfizer.
Professor of Medicine
Director, Leukemia Program
Division of Hematologic Malignancies and Cellular Therapy
Duke University School of Medicine
Disclosures: Grant Research Support: Daiichi Sankyo, GlycoMimetics (clinical trial funding paid to university), ImmunoGen; Consultant: AbbVie, Agios, Astellas, Celgene, Daiichi Sankyo, GlycoMimetics, ImmunoGen, Incyte, Jazz Pharmaceuticals, MacroGenics, Novartis, Pfizer, Seattle Genetics; Speakers Bureau: Agios, Celgene, Incyte, Jazz, Novartis; Other: Covance (chair, Independent Review Committee), GlycoMimetics (chair, DSMB), Celgene (chair, Scientific Steering Committee for AML Registry Study).
Associate Professor of Medicine
Harvard Medical School
Program Director, Center for Leukemia
Massachusetts General Hospital
Disclosures: Grant Research Support: Agios, Celgene, Takeda; Consultant: Astellas, Agios, Boston Biomedical, Celgene, Daiichi Sankyo, Jazz Pharmaceuticals, Takeda.
Department of Leukemia
Division of Cancer Medicine
The University of MD Anderson Cancer Center
Disclosures: Grant Research Support: AbbVie, Amgen, Bristol-Myers Squibb, BioLineRx, Celgene, Jazz Pharmaceuticals, Pfizer; Consultant: Amgen, Genentech, Jazz Pharmaceuticals, Novartis, Pfizer, Takeda.
The staff of Physicians' Education Resource®, LLC (PER®), have no relevant financial relationships with commercial interests to disclose.
Disclosure Policy and Resolution of Conflicts of Interest (COI)
As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME/CE activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME/CE activity to disclose all relevant financial relationships with commercial interests. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a COI.
Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process.
Off-Label Disclosure and Disclaimer
This CME/CE activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME/CE activity is for continuing medical and nursing education purposes only and is not meant to substitute for the independent clinical judgment of a physician and nurse relative to diagnostic or treatment options for a specific patient’s medical condition.
The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER®.
PER Pulse™ Recaps
1 of 3
Insight from Naval G. Daver, MD–PER Pulse™ Recap: Show Me the Data™: Leveraging Evidence to Optimize Applications of Novel Therapies in AML
Community Practice Connections™: Show Me the Data™: Leveraging Evidence to Optimize Applications of Novel Therapies in AML is a continuing medical education–certified program. For this program, chair Naval G. Daver, MD, was joined by Harry P. Erba, MD, PhD; Amir T. Fathi, MD; and Tapan M. Kadia, MD to discuss the latest data in AML.
This first of 3 PER Pulse™ Recaps summarizing the online activity focuses on strategies for individualizing decision making with regard to appropriate use of an expanding range of treatments across acute myeloid leukemia (AML). Below are some highlights from the activity featuring Dr Daver:
- Several medications were approved in 2017 and 2018 for the treatment of AML, including a liposomal formulation of cytarabine/daunorubicin, an FLT3 inhibitor, a B-cell lymphoma 2 inhibitor, and others.
- Compared with a standard daunorubicin and cytarabine (7+3) regimen, liposomal daunorubicin and cytarabine in patients aged 60 to 75 years significantly improved median overall survival (OS) duration (9.6 vs 5.9 months; HR, 0.69; 95% CI, 0.52-0.90; P = .005).1
- Complete response rates with venetoclax in combination with azacitidine, decitabine, and low-dose cytarabine were 37%, 54%, and 21%, respectively, at the time of follow-up in patients aged ≥75 years with newly diagnosed AML with comorbidities that would disqualify them for use of intensive induction chemotherapy.2,3
- Incorporating these treatments into clinical practice requires extensive collaboration among multidisciplinary healthcare professionals across centers, screening patients for cytogenetic and molecular abnormalities, and use of treatments in appropriate patient groups to optimize outcomes across the care continuum.
“The next step will be to see how we can potentially bring all of these agents together in either a combination or sequential approach” – Naval G. Daver, MD
- Lancet JE, Uy GL, Cortes JE, et al. CPX-351 (cytarabine and daunorubicin) liposome for injection versus conventional cytarabine plus daunorubicin in older patients with newly diagnosed secondary acute myeloid leukemia. J Clin Oncol. 2018;36(26):2684-2692. doi: 10.1200/JCO.2017.77.6112.
- FDA approves venetoclax in combination for AML in adults [news release]. Silver Spring, MD: FDA; November 21, 2018. fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626499.htm. Accessed August 20, 2019.
- AbbVie receives US FDA accelerated approval for VENCLEXTA® (venetoclax) for treatment of newly-diagnosed acute myeloid leukemia patients ineligible for intensive chemotherapy [news release]. North Chicago, IL: AbbVie; November 21, 2018. news.abbvie.com/news/abbvie-receives-us-fda-accelerated-approval-for-venclexta-venetoclax-for-treatment-newly-diagnosed-acute-myeloid-leukemia-patients-ineligible-for-intensive-chemotherapy.htm. Accessed August 20, 2019.
2 of 3
Insight from Harry P. Erba, MD, PhD–PER Pulse™ Recap: Show Me the Data™: Leveraging Evidence to Optimize Applications of Novel Therapies in AML
Community Practice Connections™: Show Me the Data™: Leveraging Evidence to Optimize Applications of Novel Therapies in AML is a continuing medical education–certified program. For this program, Harry P. Erba, MD, PhD, was joined by Naval G. Daver, MD; Amir T. Fathi, MD; and Tapan M. Kadia, MD to discuss the latest data in AML.
This second of 3 PER Pulse™ Recaps summarizing the online activity focuses on strategies for individualizing decision making with regard to appropriate use of an expanding range of treatments across AML. Below are some highlights from the activity featuring Dr Erba:
- In AML, recommended mutational panel tests include IDH1, IDH2, TET2, WT1, DNMT3A, and/or TP53. In addition to mutational analysis, fluorescence in situ hybridization, risk stratification based on cytogenetics, cell morphology, and immunophenotype testing may be useful in some circumstances.1,2
- Several studies have shown the predictive power of minimal residual disease (MRD) detection in predicting the cumulative incidence of relapse following effective treatment and transplant.3-5
- There are multiple challenges in the routine use of MRD detection for AML management, including a lack of universal antigenic markers, a lack of interlaboratory standardization of technologies and cutoff values, and a lack of interventions that have proved effective for MRD-positive patients who have achieved complete response.6
“Risk stratification is not just for prognostication, but now can actually be, in fact, applied to choices in therapy” – Harry P. Erba, MD, PhD
- Arber DA, Borowitz MJ, Cessna M, et al. Initial diagnostic workup of acute leukemia: guideline from the College of American Pathologists and the American Society of Hematology. Arch Pathol Lab Med. 2017;141(10):1342-1393. doi: 10.5858/arpa.2016-0504-CP.
- Döhner H, Estey E, Grimwade D, et al. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017;129(4):424-447. doi: 10.1182/blood-2016-08-733196.
- Terwijn M, van Putten WL, Kelder A, et al. High prognostic impact of flow cytometric minimal residual disease detection in acute myeloid leukemia: data from the HOVON/SAKK AML 42A study. J Clin Oncol. 2013;31(31):3889-3897. doi: 10.1200/JCO.2012.45.9628.
- Araki D, Wood BL, Othus M, et al. Allogeneic hematopoietic cell transplantation for acute myeloid leukemia: time to move toward a minimal residual disease-based definition of complete remission? J Clin Oncol. 2016;34(4):329-336. doi: 10.1200/JCO.2015.63.3826.
- Jongen-Lavrencic M, Grob T, Hanekamp D, et al. Molecular minimal residual disease in acute myeloid leukemia. N Engl J Med. 2018;378(13):1189-1199. doi: 10.1056/NEJMoa1716863.
- Ravandi F, Walter RB, Freeman SD. Evaluating measurable residual disease in acute myeloid leukemia. Blood Adv. 2018;2(11):1356-1366. doi: 10.1182/bloodadvances.2018016378.
3 of 3
Insight from Amir T. Fathi, MD–PER Pulse™ Recap: Show Me the Data™: Leveraging Evidence to Optimize Applications of Novel Therapies in AML
Community Practice Connections™: Show Me the Data™: Leveraging Evidence to Optimize Applications of Novel Therapies in AML is a continuing medical education–certified program. For this program, Amir T. Fathi, MD, was joined by Naval G. Daver, MD; Harry P. Erba, MD, PhD; and Tapan M. Kadia, MD to discuss the latest data in AML.
This third of 3 PER Pulse™ Recaps summarizing the online activity focuses on strategies for individualizing decision making with regard to appropriate use of an expanding range of treatments across AML. Below are some highlights from the activity featuring Dr Fathi:
- The NEDD8-activating enzyme inhibitor pevonedistat has been evaluated in a phase Ib trial in patients 60 years and older with treatment-naïve AML who are unfit for standard induction therapy. As bone marrow blast percentage did not affect overall response rates (ORRs) in this trial, this medication may be particularly suited to patients with a low blast percentage, and it is being evaluated in this patient population in a clinical trial known as PANTHER (NCT03268954).1-3
- The histone deacetylase (HDAC) inhibitor pracinostat has shown synergy with the DNA hypomethylating agent azacitidine. The combined increase in acetylated DNA and decrease in methylated DNA induces re-expression of silenced genes. Recent results from a phase II trial combining the 2 agents in untreated de novo or secondary AML showed an ORR of 64%, with a median OS of 19.1 months.4
- A phase III investigation of pracinostat for AML is underway in adult patients (NCT03151408), with the study currently recruiting participants. Other later-generation HDAC-targeting agents are under active late-stage investigation in AML, such as vorinostat, romidepsin, panobinostat, belinostat, and guadecitabine.5
“All of these drugs are currently under study and under clinical and preclinical development, which suggests that we will potentially have many additional compounds and novel combinations in our armamentarium as we fight this deadly disease” — Amir T. Fathi, MD
- Fathi AT. Pevonedistat, a new partner for 5-azacitidine. Blood. 2018;131(13):1391-1392. doi: 10.1182/blood-2018-02-829051.
- Swords RT, Coutre S, Maris MB, et al. Pevonedistat, a first-in-class NEDD8-activating enzyme inhibitor, combined with azacitidine in patients with AML. Blood. 2018;131(13):1415-1424. doi: 10.1182/blood-2017-09-805895.
- Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) (PANTHER). ClinicalTrials.gov/show/NCT03268954. Updated August 13, 2019. Accessed August 26, 2019.
- Atallah E, Medeiros BC, Khaled S, et al. 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). Blood. 2017;130(Suppl 1):1358.
- Suraweera A, O’Byrne KJ, Richard DJ. Combination therapy with histone deacetylase inhibitors (HDACi) for the treatment of cancer: achieving the full therapeutic potential of HDACi. Front Oncol. 2018;8:92. doi: 10.3389/fonc.2018.00092.
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