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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®, LLC, designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physicians' Education Resource®, LLC, is approved by the California Board of Registered Nursing, Provider #16669 for 2.0 Contact Hours.

Acknowledgement of Commercial Support

This activity is supported by educational grants from AbbVie Inc., Amgen, AstraZeneca Pharmaceuticals LP and Acerta Pharma, and Kite, A Gilead Company

Year in Review™: Reflecting on Recent Evidence for the Treatment of Hematologic Malignancies


Release Date: February 28, 2018
Expiration Date: February 28, 2019
Media: Internet - based

 

Activity Overview

This online activity features an expert panel discussion of noteworthy data presented at major society meetings in 2017. These findings focus on advances in specific therapeutic approaches to the treatment and management of hematologic malignancies, such as targeted therapies, immunotherapy, chemotherapy, and personalizing care through diagnostic testing.

The format for today’s YEAR IN REVIEW™ will include 5 modules of didactic presentations and interactive discussion among our panel of experts, providing insight into recent advances in chronic leukemias, acute leukemias, B-cell malignancies, myeloproliferative neoplasms (MPNs), and CAR T-cell therapies. Expert perspective will be provided on the clinical application of these data, and the future direction of the hematologic malignancy treatment landscape.

Acknowledgement of Commercial Support

This activity is supported by educational grants from AbbVie Inc., Amgen, AstraZeneca Pharmaceuticals LP and Acerta Pharma, and Kite, A Gilead Company

CME/CE Activity Table of Contents

  • Introduction
  • Module 1: Chronic Lymphocytic Leukemias
  • Module 2: Acute Leukemias
  • Module 3: B-Cell and Plasma Cell Malignancies
  • Module 4: Myeloproliferative Neoplasms
  • Module 5: CAR T-Cell Therapy and Final Remarks

Instructions for This Activity and Receiving Credit

  • You will need to login 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 videos/content until you finish the presentation.
  • At the end of the activity, “educational content/video files” will be available for your reference.
  • In order to receive a CME/CE certificate, participants 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. Participants may immediately download a CME/CE certificate upon completion of these steps.


Target Audience

This educational activity is directed toward medical oncologists, surgical oncologists, radiation oncologists, and hematologists involved in the treatment and management of patients with hematologic malignancies. Fellows, nurse practitioners, nurses, physician assistants, pharmacists, researchers, and other healthcare professionals interested in the treatment of hematologic malignancies are also invited to participate.

Learning Objectives

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

  • Outline evolving management strategies that can inform clinical decision making in the treatment of hematologic malignancies
  • Integrate clinical trial results into the management of case-based scenarios for hematologic malignancies
  • Describe approaches to proactively identify and mitigate treatment-related adverse events in patients with leukemia, lymphoma, and multiple myeloma
  • Explain the clinical significance of emerging data by placing recent findings into the context of evolving treatment paradigms for hematologic malignancies

Faculty, Staff, and Planners' Disclosures

Moderator:

Daniel J. DeAngelo, MD, PhD
Associate Professor of Medicine
Harvard Medical School
Institute Physician, Adult Leukemia Program
Dana-Farber Cancer Institute
Boston, MA

Disclosure:Grant/Research: Blueprint Pharmaceuticals; Consultant: Amgen, BMS, Incyte, Jazz, Novartis, Pfizer, Takeda, Shire

Faculty:

Jacqueline Barrientos, MD, MS
Associate Professor, Division of Hematology and Medical Oncology
Department of Medicine
Hofstra Northwell School of Medicine
Hempstead, NY
 

Disclosure:Consultant: Grant/Research: Gilead, Pharmacyclics/AbbVie; Consultant: Gilead, Pharmacyclics/AbbVie; Other ‒ Honoraria: Janssen

Brian T. Hill, MD, PhD
Director, Lymphoid Malignancies Program
Staff Physician, Department of Hematology and Medical Oncology
Taussig Cancer Institute
Assistant Professor, Cleveland Clinic
Cleveland, OH

Disclosure:Grant/Research Support: Kite Pharma Inc., Seattle Genetics; Consultant: Genentech, AbbVie, Pharmacyclics, Gilead, Novartis; Other ‒ Advisory Board: Seattle Genetics

Alexander Perl, MD
Associate Professor of Medicine
Division of Hematology/Oncology
Perelman School of Medicine
University of Pennsylvania
Philadelphia, PA

Disclosure:Consultant/Advisory Board: Astellas, Daiichi Sankyo, Arog, Novartis, Actinium Pharmaceuticals, Seattle Genetics

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/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 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 Pulse Recap (1 of 3)

In this first of 3 PER Pulse™ Recaps from the continuing medical education (CME) activity, Year in Review™: Reflecting on Recent Evidence for the Treatment of Hematologic Malignancies, Dr. DeAngelo focuses on the recent findings in myeloproliferative disorders, including chronic myeloid leukemia (CML), systemic mastocytosis, and primary myelofibrosis (MF).
 
CML
 
With the new approval in 2017 based on the findings of the BFORE trial, bosutinib has joined imatinib, dasatinib, and nilotinib as frontline targeted therapy for the treatment of CML. When choosing between the treatment options, cost remains an important consideration, but the risks and benefits of each treatment also need to be considered. Toxicity risks, such as cardiovascular, thromboembolic, hyperglycemic, and pulmonary toxicities, are important differentiators and can help guide treatment selection through risk modeling.
 
While duration of therapy with tyrosine kinase inhibitor (TKI) treatments is considered to be lifelong, studies such as the Stop Imatinib Trial (STIM) and EURO-SKI have examined the outcomes of discontinuing treatment. Both studies yielded similar results, with 41% of patients at 2 years in the STIM study, and 47% of patients at 3 years in the EURO-SKI trial, respectively, able to remain off of TKI therapy.



This argues that for these patients who have deep molecular remission, in spite of maybe achieving a complete molecular remission, that a holiday from TKI therapy can be validated. It’s important for those young women, specifically who want to have a child, or for patients who have other comorbidities that may necessitate discontinuation of their TKI therapy.” 
--  Daniel J. DeAngelo, MD, PhD

Systemic Mastocytosis
 
For patients with advanced systemic mastocytosis, midostaurin is currently the only agent approved by the US Food and Drug Administration. However, studies are ongoing with other agents, including BLU-285 (avapritinib), which has shown clinical activity along with a favorable safety profile in this patient population.
 
A phase I study of BLU-285, reported at the 2017 American Society of Hematology Annual Meeting, showed that of the 18 patients studied, 72% (n = 13) achieved an objective response, including 2 patients with complete response and 8 with partial response.

We are seeing in BLU-285, really modest toxicities. Nobody on the phase I study discontinued therapy for an adverse event, which is really unusual in a phase I study, and 100% of patients responded, based on serum tryptase levels. This is an agent that we might be able to use earlier, in smoldering or maybe even indolent, to prevent disease progression or prevent some of the side effects.”  -- Daniel J. DeAngelo, MD, PhD

Primary MF
 
While treatment with the JAK 1/2 inhibitor ruxolitinib remains the standard of care for patients with MF, studies of such novel agents as momelotinib and pacritinib are showing some promise.
 
In the phase III SIMPLIFY-1 trial, momelotinib met the primary endpoint of noninferiority versus ruxolitinib; however, the secondary endpoint of response rate in total symptom score was not met. Pacritinib is being studied for the treatment of patients with intermediate- and high-risk MF with low platelet counts (<50,000/µL), and currently no agents are approved for this patient population.
 
For additional commentary about these topics and others, visit www.gotoper.com to access more resources from this and other meetings.


PER Pulse Recap (2 of 3)

In this second of 3 PER Pulse™ Recaps from the continuing medical education (CME) activity, Year in Review™: Reflecting on Recent Evidence for the Treatment of Hematologic Malignancies, Dr. Perl focuses on updates in acute leukemias, including new drug approvals in acute myeloid leukemia (AML) providing promising treatment options. Dr. Perl highlights the safety and efficacy findings of multiple studies in patients with AML.
 
The safety and efficacy of venetoclax (VEN) in combination with decitabine (DEC) or azacitidine (AZA) in treatment-naïve patients age ≥65 years with AML was presented at the 22nd Congress of the European Hematology Association in 2017.1 The group studied was ineligible for standard induction therapy, with limited treatment options and low overall survival (OS).
 
The safety profile showed that incidence of adverse events (AEs) was similar among the 4 treatment arms:
 
  • 40 patients (40%) had an interruption of VEN between cycle 1 and cycle 2 to permit absolute neutrophil count recovery
  • 35 patients (35%) had AEs that led to VEN dose interruptions
 
Efficacy findings showed promising clinical activity with objective response rate (complete remission [CR] + complete remission with incomplete marrow recovery) of 68%, with a range of 56% to 76% in the various treatment arms. These rates are similar to those expected from induction chemotherapy.



What’s very exciting about this is the durability of survival, and indeed, PFS was quite long. The data as presented at EHA showed that median survival had not been reached, and when updated at ASH, the median survival was about 18 months, which is really quite good for this population.”  -- Alexander Perl, MD

Approximately 20% of patients with AML have IDH mutations, with about 6% to 10% with mutations in IDH1 and 9% to 13% with mutations in IDH2. In 2017, enasidenib was approved for patients with relapsed or refractory IDH2-mutated AML, based on findings from a phase I/II study that showed CR rates of about 20% with limited AEs.2 A New Drug Application has been submitted for ivosidenib, an IDH1 inhibitor, with approval expected in 2018.
 
A novel form of daunorubicin and cytarabine, CPX-351, was approved by the US Food and Drug Administration in 2017 for patients with secondary AML. The approval was based on a phase III study of adult patients with newly diagnosed, therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Compared with standard 7+3 therapy, treatment with CPX-351 showed a statistically significant improvement in OS. A subgroup analysis of patients undergoing allogeneic hematopoietic stem cell transplantation, presented at the 2017 American Society of Hematology Annual Meeting, showed not only an improvement of OS, but also a reduction in the risk of early death in this group of patients with limited treatment options and low survival rates.

This is a population that you’d like to take to transplant, once in remission. If we look at an analysis of patients who did go on to transplant, the benefit of CPX-351 was actually seen more dramatically in patients who did go to transplant, as presented at ASH this past year.”  -- Alexander Perl, MD

In some cases, the indication for the new approvals does not exactly mirror the clinical trial populations, making evidence-based decision making challenging. Clinicians are encouraged to apply clinical judgment and nuance to select the agent that leads to the best survival for each patient.
 
For additional commentary about these topics and others, visit www.gotoper.com to access more resources from this and other meetings.
 
References
  1. Pratz K, Pollyea D, Jonas B, et al. Safety and efficacy of venetoclax (VEN) in combination with decitabine or azacitidine in treatment-naïve, elderly patients (≥65 years) with acute myeloid leukemia (AML). Presented at the 22nd Congress of the European Hematology Association; June 22-25, 2017; Madrid, Spain. Abstract S472.
  2. Stein EM, DiNardo CD, Pollyea DA, et al. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood. 2017;130(6):722-731.

PER Pulse Recap (3 of 3)

In this third of 3 PER Pulse™ Recaps from the continuing medical education (CME) activity, Year in Review™: Reflecting on Recent Evidence for the Treatment of Hematologic Malignancies, Dr. Hill focuses on findings from the ZUMA-1 study in patients with refractory, aggressive non-Hodgkin lymphoma (NHL).
 
In 2017, the American Society of Clinical Oncology named adoptive cell immunotherapy as the clinical cancer advance of the year. Following decades of research, chimeric antigen receptor (CAR) T-cell therapy has become available for some patients with otherwise incurable forms of cancer.
 
Axicabtagene ciloleucel (axi-cel), an autologous, anti-CD19, CAR T-cell therapy was studied in patients with refractory, aggressive NHL in the ZUMA-1 trial, and the findings were presented at the 2017 American Society of Hematology Annual Meeting.1 Historically, patients with refractory large B-cell lymphoma, have been shown to have a very poor prognosis, with low rates of complete remission (CR) and median overall survival (OS) of 6.3 months, based on the SCHOLAR-1 data.2
 
Most of the patients in ZUMA-1 had stage III/IV disease. Most patients were refractory to second- or greater line of therapy, and the majority of the patients had progressive disease as the best overall response to their last prior therapy.
 
Efficacy
 
The objective response rate was 82% overall, with 54% CR rate. Durability of response after a median follow-up of 15.4 months showed that 42% of the patients continued to have a response, with 40% of patients continuing a CR.
 
In patients who achieved a CR with axi-cel therapy, about 70% of those patients were able to maintain that remission at 12 months, but progressions were very rapid in those who achieved less than a CR.



I think it’s important to understand that this is a therapy that can only be given at authorized treatment centers. This needs to be given at a center that has experience, usually through clinical trials previously. There are specific guidelines provided by the manufacturer and a specific REMS training program.”  -- Brian T. Hill, MD, PhD

Safety
 
The most notable toxicities are cytokine release syndrome (CRS) and neurologic toxicities. The most common grade ≥3 adverse events during treatment were neutropenia (78%), anemia (43%), and thrombocytopenia (38%). Grade ≥3 CRS occurred in 13% of patients and neurologic events in 28% of the patients treated. Three patients died during treatment.
 
The CRS can also be dramatic and consist of hypotension, fever, sometimes requiring vasopressor support.  

In the cases that did not achieve a CR or relapsed later, among the biopsies that were obtained, about a third had lost CD19 expression. It was also noted that PD-L1 expression was higher than the pre-CAR T-cell therapy in some of the cases as well. I think checkpoints are going to play a role in conferring resistance to CAR T.”  -- Brian T. Hill, MD, PhD

For additional commentary about these topics and others, visit www.gotoper.com to access more resources from this and other meetings.
 
References
  1. Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377(26):2531-2544.
  2. Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800-1808.








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