Join us on Tuesday, January 5^th for this CME/MOC-accredited webinar
5:00 PM – 6:00 PM ET

This activity is supported by educational grants from Astellas, Bristol-Myers Squibb Company, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc and Taiho Oncology Inc.

Tuesday, January 5, 2021
5:00 PM – 6:00 PM ET
Live CME/MOC-accredited webinar

Topics to Be Discussed

MODULE 1: Tailoring Therapy for Older and Younger Patients with Acute Myeloid Leukemia (AML)

• 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 and low-dose cytarabine, respectively, as first-line treatment for patients with AML who are ineligible for intensive chemotherapy
• Investigation of venetoclax for younger, fit patients with newly diagnosed AML; current off-protocol role for younger individuals with poor-risk disease
• Clinical trial database underlying the FDA approval of gilteritinib for patients with relapsed/refractory (R/R) AML with a FLT3 mutation; early data with and ongoing investigation of gilteritinib in the front-line and maintenance settings
• Key efficacy and safety findings from the Phase III QuANTUM-R trial comparing quizartinib to salvage chemotherapy for patients with R/R AML with FLT3 mutations; ongoing Phase III evaluation in the front-line setting (QuANTUM-First)
• Long-term follow-up data supporting the FDA approval of enasidenib for R/R AML with an IDH2 mutation; activity, safety and current nonresearch role for patients with newly diagnosed disease
• Efficacy and safety findings leading to the FDA approval of ivosidenib for patients with R/R AML with IDH1 mutations and those with newly diagnosed disease who are older or ineligible for intensive induction chemotherapy
• Design, eligibility criteria and primary and secondary endpoints achieved in the Phase III QUAZAR AML-001 study assessing CC-486 as maintenance therapy; FDA priority review status and potential clinical role
• Mechanism of action of guadecitabine; efficacy and safety observed in the Phase III ASTRAL-1 study for patients with treatment-naïve AML not eligible for intensive chemotherapy

MODULE 2: Optimal Management of Secondary AML; Current and Future Treatment Considerations for Patients with Myelodysplastic Syndromes (MDS)

• Biologic mechanism for the development and prevalence of secondary AML in patients who have received prior anticancer therapy and in those with a history of other hematologic cancers
• Long-term efficacy and safety observed with CPX-351 in the pivotal Phase III trial comparing it to standard 7 + 3 for newly diagnosed secondary AML; practical integration of CPX-351 into clinical management
• Ongoing and planned clinical trials evaluating CPX-351 in the treatment of primary AML or in combination with other agents
• 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 versus 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 and timing of introduction
• Activity observed with and current nonresearch roles of approved AML therapies (eg, venetoclax, ivosidenib, enasidenib) for patients with MDS
• Ongoing evaluation of CC-486 to manage thrombocytopenia in patients with low-risk MDS
• Early tolerability and efficacy findings with the anti-CD47 antibody magrolimab combined with azacitidine for patients with high-risk MDS; development plans
• Prevalence of TP53 mutations in MDS; mechanism of action of eprenetapopt and clinical trial findings contributing to its FDA breakthrough therapy designation for MDS with TP53 mutation

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

Learning Objectives
Upon completion of this activity, participants should be able to

• 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 or 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.
• 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.
• Review Phase III data documenting the efficacy of CC-486 as maintenance therapy for patients with newly diagnosed AML who attained first complete response or complete response with incomplete blood count recovery with induction chemotherapy, and consider how this novel strategy may affect future clinical decision-making.
• Recall 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 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 IDH1 or 2 mutations.
• Formulate a treatment algorithm for 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 Credit™. 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 each CME activity, which includes participation in the evaluation component and a short post-test, 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 specialties: medical oncology and hematology.

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.

Content Validation and Disclosures
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 — The following faculty (and their spouses/partners) reported relevant conflicts of interest, which have been resolved through a conflict of interest resolution process:

Dr Sekeres — Advisory Committee: Bristol-Myers Squibb Company, Celgene Corporation, Takeda Oncology. Dr Stone — Advisory Committee and Consulting Agreements: AbbVie Inc, Actinium Pharmaceuticals Inc, Aprea Therapeutics, BerGenBio ASA, ElevateBio, Foghorn Therapeutics, GEMoaB, GlaxoSmithKline, Innate Pharma, Syndax Pharmaceuticals Inc, Syros Pharmaceuticals Inc, Takeda Oncology; Contracted Research: Agios Pharmaceuticals Inc, Novartis; Data and Safety Monitoring Board/Committee: ACI Clinical, Syntrix Pharmaceuticals, Takeda Oncology.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following commercial interests: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Adaptive Biotechnologies Corporation, Agendia Inc, Agios Pharmaceuticals Inc, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Biodesix Inc, bioTheranostics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, EMD Serono Inc, Epizyme Inc, Exact Sciences Inc, Exelixis Inc, Foundation Medicine, Genentech, a member of the Roche Group, Genmab, Gilead Sciences Inc, GlaxoSmithKline, Grail Inc, Guardant Health, Halozyme Inc, Helsinn Healthcare SA, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Lexicon Pharmaceuticals Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Merrimack Pharmaceuticals Inc, Myriad Genetic Laboratories Inc, Natera Inc, Novartis, Novocure Inc, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Prometheus Laboratories Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sandoz Inc, a Novartis Division, Sanofi Genzyme, Seagen Inc, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Sumitomo Dainippon Pharma Oncology Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, Teva Oncology, Tokai Pharmaceuticals Inc and Verastem Inc.

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.

This activity is supported by educational grants from Astellas, Bristol-Myers Squibb Company, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc and Taiho Oncology Inc.