Release Date: May 30, 2018
Expiration Date: May 30, 2019
Media: Internet - based
Community Practice Connections™: 22nd Annual International Congress on Hematologic Malignancies®: Focus on Leukemias, Lymphomas, and Myeloma consists of a series of interactive clinical vignettes, short video interviews with leading experts in hematologic malignancies, and short summaries of clinical data related to these issues. The video interviews address decision points in the clinical vignettes, as well as questions commonly faced in the community oncology practice setting.
Acknowledgement of Commercial Support
This activity is supported by educational grants from AbbVie, Adaptive Biotechnologies, Astellas, AstraZeneca, Bristol-Myers Squibb, Celgene Corporation, Daiichi Sankyo, Inc., Foundation Medicine, Inc., Gilead Sciences, Inc., Jazz Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Seattle Genetics, Inc., and Takeda Oncology.
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.
This educational activity is directed toward community-based hematologists and medical oncologists, as well as fellows involved in the treatment and management of patients with hematologic malignancies. Nurse practitioners, nurses, physician assistants, pharmacists, researchers, and other healthcare professionals involved in the treatment and management of patients with hematologic malignancies may also participate.
At the conclusion of this activity, you should be better prepared to:
Examine the role of biomarkers in risk stratification and treatment guidance for patients with hematologic malignancies
Apply key safety and efficacy information from recent clinical trials to the management of hematologic malignancies in a variety of settings
Develop evidence-based strategies to address predictable treatment-related toxicities in patients with hematologic malignancies
Outline recent clinical trial findings pertaining to the use of novel compounds and/or strategies in the management of hematologic malignancies
Recognize the therapeutic implications of emerging data for evolving treatment paradigms
Faculty, Staff, and Planners' Disclosures
John C. Byrd, MD
D. Warren Brown Chair of Leukemia Research
Distinguished University Professor of Medicine,
Medicinal Chemistry, and Veterinary Biosciences
The Ohio State University
Disclosure: Grant/Research Support: Genentech, Acerta Pharma, Pharmacyclics, Janssen Pharmaceutical Companies of Johnson & Johnson.
Jorge Cortes, MD
Jane and John Justin Distinguished Chair in Leukemia Research
Chief, CML & AML Sections
Deputy Chair, Department of Leukemia
The University of Texas MD Anderson Cancer Center
Disclosure: Grant/Research Support: Araid, Bristol-Myers Squibb, Pfizer, Teva Pharmaceuticals Industries, Ltd, Novartis; Consultant: Araid, Bristol-Myers Squibb, Novartis, Pfizer.
Steven Coutre, MD
Professor of Medicine (Hematology)
The Stanford University Medical Center
Disclosure: Grant/Research Support: Celgene, Pharmacyclics, AbbVie, Gilead Sciences, Inc., Acerta, Janssen Pharmaceutical Companies of Johnson & Johnson; Consultant: Celgene, Novartis, Pharmacyclics, Gilead Sciences, Inc., AbbVie, Acerta.
Andre H. Goy, MD, MS
Chairman and Executive Director
Lymphoma Division Chief - John Theurer Cancer Center
Chief Science Officer – RCCA
Lydia Pfund Chair for Lymphoma
Professor of Medicine, Georgetown University
Disclosure: Grant/Research Support: Johnson & Johnson, Celgene, Gilead/Kite clinical trial support through institution; Consultant: Celgene; Speakers Bureau: Takeda, Johnson & Johnson/Pharmacyclics, Gilead/Kite; Other: Member on Advisory Board: Celgene, Takeda, Pharmacyclics, Johnson & Johnson, Acerta, Gilead/ Kite.
Sagar Lonial, MD, FACP
Professor, Emory School of Medicine
Chair, Department of Hematology & Medical Oncology
Chief Medical Officer
Winship Cancer Institute of Emory University
Disclosure: Consultant: Merck, Novartis, Onyx Pharmaceuticals, Millennium Pharmaceuticals, Bristol-Myers Squibb, Sanofi, Celgene, Janssen Pharmaceutical Companies of Johnson & Johnson.
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)
This first of 3 PER Pulse™ Recaps will focus on evidence supporting the use of chimeric antigen receptor (CAR) T cells in patients with lymphoma. Below are some highlights from the activity:
In the multicenter phase II ZUMA-1 trial, 111 patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, or transformed follicular lymphoma with refractory disease subsequent to recommended lines of previous therapy received CAR T-cell therapy. The primary endpoint was overall response rate (ORR; complete response [CR] + partial response [PR]), and the results are shown in Table 1
. Axi-cel demonstrated an acceptable safety profile as shown in Table 2
. Dr. Goy highlights the efficacy and safety of CAR T-cell therapy.
“CAR T-cell therapy is something that is a game changer. In our study, ZUMA-1, at the follow- up of 15 months, 42% of the patients were still doing well and there are potentially some patients that are cured. One of the issues with CAR T cells is the toxicity, particularly cytokine release syndrome (CRS) and neurotoxicity. CRS can be mitigated by tocilizumab, an anti-IL-6, and that does not affect the outcome of the response.”
— Andre H. Goy, MD, MS
In August 2017, tocilizumab, an anti–IL-6 antibody, was approved for the management of cytokine release syndrome (CRS) associated with CAR T-cell therapy.2
On the same day, tisagenlecleucel became the first US Food and Drug Administration (FDA)-approved CAR T-cell immunotherapy for the treatment of B-cell acute lymphoblastic leukemia (ALL) based on the results from the phase II ELIANA trial (Tables 3 and 4
In May 2018, tisagenlecleucel was FDA-approved for the treatment of relapsed/refractory (R/R) large B-cell lymphoma based on the results of the JULIET trial (not shown).4
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. https://doi.org/10.1056/NEJMoa1707447.
FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine release syndrome [press release]. Silver Spring, MD: US Food and Drug Administration; August 30, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm574154.htm. Accessed May 2, 2018.
Maude SL, Laetsch TW, Buechner J, et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018;378(5):439-448. DOI: 10.1056/NEJMoa1709866.
FDA website. KYMRIAH (tisagenlecleucel). https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM606523.pdf. Accessed May 3, 2018.
PER Pulse Recap (2 of 3)
This second of 3 PER Pulse™ Recaps will focus on newer treatment options for patients with acute myeloid leukemia (AML).
“With acute myeloid leukemia, the landscape has changed, thankfully, because of newer agents. We also have a lot more insight into biological features of the disease that have become relevant in terms of our choice of therapies and how we monitor patients. Cytogenetics are incredibly important in terms of post-remission therapy and sometimes influencing choice of initial treatment.” — Steven Coutre, MD
Below are some highlights from the activity featuring Dr. Coutre:
Mutations in isocitrate dehydrogenase 2 (IDH2) occur in approximately 12% of patients with AML. A recent phase I/II study assessed safety, maximum tolerated dose, and clinical activity of enasidenib in patients with mutated IDH2,
advanced myeloid malignancies, with updated results presented at the 2017 European Hematology Association annual meeting.1,2
Efficacy results showed that enasidenib yielded CRs in patients with R/R AML (Table 1
), and was associated with overall survival (OS) of >9 months in patients who had failed prior AML treatments. Overall, enasidenib was well tolerated (Table 2
For patients with R/R AML and an IDH1
mutation, 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 FDA in 2017 for patients with secondary AML. Compared with standard 7+3 therapy, treatment with CPX-351 demonstrated a statistically significant improvement in OS and tolerable safety profile (Tables 3 and 4
Stein EM, DiNardo CD, Pollyea DA, et al. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood. 2017;130(6):722-731. doi: 10.1182/blood-2017-04-779405.
Stein EM, DiNardo CD, Pollyea DA, et al. Enasidenib (AG-221) in mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML): results of a phase 1 dose-escalation and expansion study. Presented at the 2017 Annual Meeting of the European Hematology Association; June 22-25, 2017; Madrid, Spain. Abstract S471.
Lancet JE, Uy GL, Cortes JE, et al. Final results of a phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML. Presented at the 2016 Annual Meeting of the American Society of Clinical Oncology; June 3-7, 2016; Chicago, IL. Abstract 7000.
PER Pulse Recap (3 of 3)
This third of 3 PER Pulse™ Recaps will focus on recent trial findings for patients with multiple myeloma (MM).
In the open-label phase III Southwest Oncology Group (SWOG) S0777 trial, the efficacy and safety of bortezomib with lenalidomide and dexamethasone (VRd) versus lenalidomide and dexamethasone alone (Rd) was evaluated in patients with newly diagnosed MM who did not intend to receive immediate autologous stem cell transplant (ASCT).1
The triplet regimen yielded significant increases in both progression-free survival (PFS) and OS (Table 1
“I think that there are a number of trials that have demonstrated that for both transplant-eligible and transplant-ineligible patients, triplets are superior to doublets in terms of progression-free and, ultimately, overall survival.”
A recent phase III trial, ALCYONE, evaluated bortezomib/melphalan/prednisone (VMP) versus VMP plus daratumumab (D+VMP) in patients with newly diagnosed MM who were ineligible for ASCT.2
The primary endpoint of PFS was met (Table 2
). Efficacy results include a highly significant increase in ORR (Table 3
). Grade 3/4 adverse events in the D + VMP arm included neutropenia (40%) and thrombocytopenia (34%) (Table 4
Durie BG, Hoering A, Abidi MH, et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. Lancet. 2017;389(10068):519-527. doi: 10.1016/S0140-6736(16)31594-X.
Mateos MV, Dimopoulos MA, Cavo M, et al. Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma. N Engl J Med. 2018;378(6):518-528. DOI: 10.1056/NEJMoa1714678.
For additional commentary about these topics and others, visit www.gotoper.com
to access more resources from the archived 22nd Annual International Congress on Hematologic Malignancies®: Focus on Leukemias, Lymphomas, and Myeloma