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Accreditation/Credit Designation

Physicians' Education Resource®, LLC,is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians' Education Resource® designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Acknowledgment of Commercial Support

This activity is supported by an educational grant from Agios Pharmaceuticals, Inc.

Cancer Summaries and Commentaries™: Update from Atlanta – Advances in the Treatment of Acute Myeloid Leukemia


Release Date: March 30, 2018
Expiration Date: March 30, 2019
Media: Internet - based

 

Activity Overview

This online activity is designed to update physicians on data presented at a major oncology meeting, held in Atlanta, GA, in December 2017, to facilitate critical assessment and, when appropriate, clinical integration of new evidence. The activity reviews 3 abstracts selected by program faculty, Amir T. Fathi, MD, MSc, as the most compelling and clinically relevant from the meeting. For each abstract, a short summary of key clinical data is accompanied by expert perspectives that provide insight into how clinicians can apply these findings to their clinical practice to improve patient care. Interactive questions are interspersed throughout the activity to encourage engagement, learning, and self-assessment.

Acknowledgement of Commercial Support

This activity is supported by an educational grant from Agios Pharmaceuticals, Inc.

CME Activity Table of Contents

  • Module 1: Preliminary Results from a Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Subjects with Newly Diagnosed Acute Myeloid Leukemia
  • Module2: The Use of Ivosidenib (AG-120) in Mutant IDH1 AML and Advanced Hematologic Malignancies: Results of a Phase 1 Dose Escalation and Expansion Study
  • Module2: Analysis of the Safety and Efficacy of Enasidenib Monotherapy in Older Patients with Previously Untreated Mutant-IDH2 (mIDH2) Acute Myeloid Leukemia (AML)

Instructions for This Activity and Receiving Credit

  • You will need to log in to participate in the activity.
  • Each presentation may contain an interactive question(s). You may move forward through the presentation; however, you may not go back to change answers or review audio files/content until you finish the presentation.
  • At the end of the activity, educational content/audio files will be available for your reference.
  • In order to receive a CME certificate, you must complete the activity.
  • Complete the Posttest and pass with a score of 70% or higher, complete the Evaluation, and then click on “Request for Credit.” You may immediately download a CME certificate upon completion of these steps.


Target Audience

This activity is directed toward medical oncologists who treat patients with acute myeloid leukemia (AML). Fellows, nurses, nurse practitioners, physician assistants, and other healthcare professionals involved in the management of patients with AML are also invited to participate.

Learning Objectives

At the conclusion of this activity, you should be better prepared to:

  • Detail the design, efficacy, and safety endpoints of ongoing and recently completed clinical trials in patients with AML
  • Explain recent clinical trial results regarding novel compounds and strategies for patients with AML
  • Place presented clinical trial evidence into the context of evolving treatment paradigms and strategies in the management of patients with AML

Faculty, Staff, and Planners' Disclosures

Faculty

Amir T. Fathi, MD, MSc
Assistant Professor of Medicine
Harvard Medical School
Director, Leukemia Program
Massachusetts General Hospital
Boston, MA

Disclosure:Consultant: Amgen, Astellas, Celgene, GlaxoSmithKline, Janssen Oncology, Aptose Biosciences Inc., Vaniam Group LLC, AbbVie, Alexion; Research Support: Kite, Regeneron, Acerta; Consultant/Research Support: Gilead, Pharmacyclics, TG Therapeutics, Pfizer, Sunesis.

The staff of 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 activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME 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 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 activity is for continuing medical and nursing education purposes only, and is not meant to substitute for the independent clinical judgment of a physician relative to diagnostic, treatment, or management 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™ Recap

PER Pules Recap (1 of 3)

This first of 3 PER Pulse™ Recaps from the continuing medical education (CME) activity, Cancer Summaries and Commentaries™: Update from Atlanta – Advances in the Treatment of Acute Myeloid Leukemia, reviews emerging clinical data on ivosidenib, a potent, selective oral inhibitor of mutant IDH1 (mIDH1), currently under priority review by the US Food and Drug Administration for the treatment of relapsed or refractory (R/R) mIDH1 acute myeloid leukemia (AML).1
 
The safety of ivosidenib in patients with mIDH1 advanced hematologic malignancies (including R/R AML, untreated AML ineligible for standard of care, and other non-AML R/R advanced hematologic malignancies) is being investigated in an open-label, multicenter, phase I, dose-escalation and -expansion study (NCT02074839).2
 
Here are some study highlights presented at the 2017 American Society of Hematology annual meeting:
  • Patients received daily oral ivosidenib monotherapy in 28-day cycles (twice daily, 100 mg; once daily [QD], 300 mg, 500 mg, 800 mg, and 1200 mg)
  • Although maxmum tolerated dose (MTD) was not reached, the expansion-phase dose was conducted at 500 mg QD
  • In 258 patients receiving ≥1 doses of ivosidenib, treatment-emergent adverse events (TEAEs) were primarily low grade (grade 1-2) and reported as unrelated to study treatment.
  • AEs of interest included leukocytosis (30%), QT prolongation (23%), and IDH differentiation syndrome (11.2%) 
  • In patients with R/R AML (n=125), complete response (CR) + CR with partial hematologic recovery (CRh) response rate was 30.4%, including CR in 27 patients (21.6%) and with a median duration of response of 8.2 months
  • The majority of responders achieved transfusion independence
“If a sizeable portion of patients with relapsed/refractory AML can potentially be placed into remission or some degree of disease control or response with an oral pill that is very well tolerated, I think that is a remarkable advance.”
  
“Ultimately, we will have to see what will happen with these patients and whether this drug will become available, but I think the data are quite promising in terms of both tolerability and efficacy.”  
                                               -- Amir T. Fathi, MD, MSc

References
1.  FDA accepts new drug application and grants priority review for ivosidenib in relapsed or refractory AML with an IDH1 mutation [press release]. http://investor.agios.com/news-releases/news-release-details/fda-accepts-new-drug-application-and-grants-priority-review-0. February 5, 2018. Accessed April 25, 2018.
2.  DiNardo CD, DeBotton S, Stein EM, et al. Ivosidenib (AG-120) in Mutant IDH1 AML and Advanced Hematologic Malignancies: Results of a Phase 1 Dose Escalation and Expansion Study. Presented at the 59th ASH Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA. Abstract 725.
 
For additional commentary about emerging clinical data on novel agents in AML and other topics, visit www.gotoper.com.


PER Pules Recap (2 of 3)
 
This second of 3 PER Pulse™ Recaps from the continuing medical education (CME) activity, Cancer Summaries and Commentaries™: Update from Atlanta – Advances in the Treatment of Acute Myeloid Leukemia, reviews emerging clinical data on gilteritinib, a highly-specific, oral inhibitor of FLT3/AXL with activity against both identified classes of FLT3 activating mutations: FLT3-internal tandem duplication (FLT3-ITD) and FLT3-tyrosine kinase domain (FLT3-TKD).1
 
An ongoing open-label, dose-escalation/-expansion phase I study (NCT02236013) is evaluating the safety and tolerability of gilteritinib in combination with well-established induction and consolidation chemotherapy in adult patients with newly diagnosed AML, including those with mutated or wild-type FLT3.2
 
Here are some highlights from the initial study results presented at the 2017 American Society of Hematology annual meeting:
 
  • Although the maximum tolerated dose (MTD) was not reached, gilteritinib 120 mg/day was selected for dose expansion; dose escalation in the 200-mg/day gilteritinib cohort is ongoing
  • Adverse events in patients receiving ≥1 dose of gilteritinib (n=49) were similar to those seen with induction chemotherapy, including febrile neutropenia (53.1%), thrombocytopenia (18.4%), neutropenia (16.3%), decreased platelet count (12.2%), sepsis (10.2%), and decreased white blood cell count (10.2%)

“The first generation of FLT3 inhibitors are not as potent or selective as the newly developed FLT3 inhibitors such as quizartinib, crenolanib, or gilteritinib.”
 
“Time will tell whether gilteritinib in combination with standard chemotherapy will be more pervasively used than less specific FLT3 inhibitors like midostaurin or serafenib. We just have to wait for the results and maturation of ongoing clinical trial data.”
                                            -- Amir T. Fathi, MD, MSc
References
  1. Perl A, Altman JK, Cortes J, et al. Selective inhibition of FLT3 by gilteritinib in relapsed or refractory acute myeloid leukaemia: a multicentre, first-in-human, open-label, phase 1-2 study. Lancet Oncol. 2017;18(8):1061-1075.
  2. Pratz K, Cherry M, Altman JK, et al. Preliminary Results from a Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Subjects with Newly Diagnosed Acute Myeloid Leukemia. Presented at the 59th ASH Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA. Abstract 722.
 
For additional commentary about emerging clinical data on novel agents in AML and other topics, visit www.gotoper.com.


PER Pules Recap (3 of 3)

This third of 3 PER Pulse™ Recaps from the continuing medical education (CME) activity, Cancer Summaries and Commentaries™: Update from Atlanta – Advances in the Treatment of Acute Myeloid Leukemia, reviews emerging clinical data on
frontline enasidenib in patients who have an IDH2 mutation (mIDH2) and were ineligible for induction chemotherapy.
 
A subgroup analysis from the phase I portions of the open-label, dose-escalation/-expansion trial (NCT01915498) evaluated the use of single-agent enasidenib in older patients with previously untreated mIDH2 AML who were not candidates for standard induction therapy.1
 
Here are some highlights of the data presented at the 2017 American Society of Hematology annual meeting:
  • Among the 37 patients with previously untreated mIDH2 AML receiving enasidanib monotherapy, the overall response rate was 37.8% with a median duration of response of 12.2 months, and included complete response in 7 patients (18.9%), partial response in 5 patients (13.5%), and morphological leukemia-free state in 2 patients (5.4%)
  • Median overall survivalOS was 19.8 months among the 14 responders and 5.4 months in nonresponders (n=23)
  • The most common treatment-emergent adverse events (TEAEs) included hyperbilirubinemia (30%) and nausea (22%); serious TEAEs included IDH differentiation syndrome (8%) and tumor lysis syndrome (2.5%)
  • Follow-up studies of enasidenib in older patients with untreated mIDH2 AML are planned, including the Beat AML Master Trial (NCT03013998)
“Enasidenib is not approved for use in the upfront setting, so we can't make the recommendation that it be used for patients in the upfront setting regardless of their age.”
 
“The data are promising and do demonstrate a decent proportion of patients who achieve response with this monotherapy, and as with relapsed/refractory patients, it appears to be well-tolerated.”
 -- Amir T. Fathi, MD, MSc

Reference
  1. Pollyea DA, Tallman MS, De Botton S, et al. Enasidenib Monotherapy Is Effective and Well-Tolerated in Patients with Previously Untreated Mutant-IDH2 (mIDH2) Acute Myeloid Leukemia (AML). Presented at the 59th ASH Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA. Abstract 638.
 
For additional commentary about emerging clinical data on novel agents in AML and other topics, visit www.gotoper.com.







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