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.

Acknowledgment of Commercial Support

This activity is supported by educational grants from GlaxoSmithKline, Karyopharm and Sanofi Genzyme.

Cancer Summaries and Commentaries™: Report From Orlando on Advancements in Multiple Myeloma

Release Date: December 24, 2019
Expiration Date: December 24, 2020
Media: Internet - based

Activity Overview

This online continuing medical education (CME) activity is designed to update physicians on data presented at the American Society of Hematology Annual Meeting, held in December 2019 in Orlando, Florida. Cancer Summaries and Commentaries™: Report From Orlando on Advancements in Multiple Myeloma facilitates the critical assessment and clinical integration of new evidence, when appropriate. The activity reviews 8 of the most clinically pertinent multiple myeloma (MM) presentations from the meeting. For each abstract, a text-based summary of the background, study design, key clinical data, and study conclusions is accompanied by expert perspectives that provide insight into how clinicians can apply these findings to their clinical practice to improve patient care.

Acknowledgement of Commercial Support

This activity is supported by educational grants from GlaxoSmithKline, Karyopharm and Sanofi Genzyme.

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 video/content until you finish the presentation.
  • At the end of the activity, “Educational Content/Audio” 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 and hematologists who treat patients with multiple myeloma. Fellows, nurses, nurse practitioners, physician assistants, and other healthcare professionals involved in the management of patients with multiple myeloma will also be invited to participate.

Learning Objectives

Upon successful completion of this educational activity, you should be better prepared to:

  • Outline novel treatment options exploring targeted therapies, immunotherapies, and combination strategies among patients with multiple myeloma
  • Explain the study design, rationale, and results of recent clinical trials evaluating novel strategies for the treatment of multiple myeloma
  • Consider best practices to apply novel treatment strategies for the management of patients with multiple

Faculty, Staff, and Planners’ Disclosures

Faculty

Ajai Chari
Ajai Chari, MD
Associate Professor of Medicine
Icahn School of Medicine at Mount Sinai
Director of Clinical Research, Multiple Myeloma Program
Associate Director, Mount Sinai Cancer Clinical Trials Office
The Mount Sinai Hospital
New York, NY

Disclosures: Grant Research Support: Amgen, Array BioPharma, Celgene, GlaxoSmithKline, Janssen, Millennium/Takeda, Novartis Pharmaceuticals, Oncoceutics, Pharmacyclics, Seattle Genetics; Consultant: Amgen, Bristol-Myers Squibb, Celgene, Millennium/Takeda, Janssen, Karyopharm Therapeutics; Other: Scientific Advisory Boards: Amgen, Celgene, Millennium/Takeda, Janssen, Karyopharm Therapeutics, Sanofi, Seattle Genetics.

Shaji Kumar
Shaji Kumar, MD
Professor of Medicine
Chair, Myeloma, Amyloidosis, Dysproteinemia Disease Group
Division of Hematology
Mayo Clinic
Rochester, MN

Disclosures: Grant Research Support: Research funding for clinical trials to the institution: Celgene, Takeda, Janssen, Bristol-Myers Squibb, Sanofi, Kite Pharma, Merck and Co, AbbVie, MedImmune, Novartis, Roche-Genentech, Amgen, TeneoBio, CARsgen Therapeutics; Consultant: Consulting/Advisory Board participation (with no personal payments): Celgene, Takeda, Janssen, KITE, Merck and Co, AbbVie, MedImmune, Genentech, Amgen, Molecular Partners. Consulting/Advisory Board participation (with personal payment): Oncopeptides, Adaptive Biotechnologies, GeneCentrix.

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 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 education purposes only and is not meant to substitute for the independent clinical judgment of a physician 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® or the company that provided commercial support.

PER Pulse™ Recaps

1 of 3

Cancer Summaries and Commentaries™: Report from Orlando on Advancements in Multiple Myeloma is a continuing medical education (CME)-certified activity designed to update physicians on data presented at the American Society of Hematology 61st Annual Meeting, held in December 2019, in Orlando, Florida. For each abstract, a text-based summary of the study background, design, key clinical data, and conclusions is accompanied by expert commentary from Shaji Kumar, MD, and Ajai Chari, MD, who provide insight into how clinicians can apply these findings to their clinical practice to improve patient care.

This first of 3 PER Pulse™ Recaps focuses on data presented in Orlando, Florida, in 2019 pertaining to treatment options in patients with relapsed/refractory multiple myeloma (RRMM). An assortment of drugs (both FDA approved and those awaiting approval) has recently been examined. Below are some highlights:

  • The phase III CANDOR trial (NCT03158688) examines the efficacy and safety of daratumumab in combination with carfilzomib and dexamethasone compared with carfilzomib and dexamethasone (Kd) in patients with RRMM.1
    • Daratumumab, a CD38-targeted monoclonal antibody, has gained approval in both combination settings and monotherapy in various populations with multiple myeloma, including both relapsed and refractory settings as well as newly diagnosed patients. Daratumumab also has indications for patients who are eligible for autologous stem cell transplants, as well as for patients who are ineligible.2
    • Study authors note that the addition of daratumumab to Kd significantly improved survival benefits across all subgroups with a 37% reduction in the risk of progression or death.1
  • The phase III BELLINI trial (NCT02755597) compares the efficacy and safety of venetoclax with bortezomib and dexamethasone (Bd) or placebo and Bd in patients with heavily pretreated RRMM.3
    • Venetoclax is an oral, selective small-molecule inhibitor of the antiapoptotic protein B-cell lymphoma 2 (BCL-2), approved for the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma. It also has approval for the treatment of acute myeloid leukemia in patients >75 years of age or in patients who are ineligible to receive chemotherapy.4
    • Data indicate improved survival benefits in patients with t(11;14)-positive RRMM or disease with high levels of expression of BCL2 who received venetoclax.
  • The phase III DREAMM-3 study (NCT04162210), planned to begin late 2019, will evaluate the efficacy and safety of belantamab mafodotin monotherapy compared with pomalidomide and dexamethasone in patients with RRMM.5
    • Belantamab mafodotin, formerly known as GSK2857916, is a monoclonal anti-B cell maturation antigen antibody that is afucosylated and conjugated to monomethyl auristatin F, a microtubule-disrupting agent.6,7
    • In the phase I study DREAMM-1/BMA117159 (NCT02064387) patients with RRMM receiving belantamab mafodotin monotherapy had a rapid, deep, and sustained response to treatment.7
    • The phase III DREAMM-3 study was initially planned to start in late 2019.5

References

  1. Usmani SZ, Quach H, Mateos M-V, et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma (RRMM): primary analysis results from the randomized, open-label, phase 3 study Candor (NCT03158688). Paper presented at: American Society of Hematology 61st Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL. Abstract LBA-6.
  2. Darzalex (daratumumab) injection [package insert]. Horsham, PA: Janssen Biotech, Inc; 2019. http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf. Accessed January 7, 2020.
  3. Harrison S, Cavo M, De La Rubia J, et al. T(11;14) and high BCL2 expression are predictive biomarkers of response to venetoclax in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma: biomarker analyses from the phase 3 bellini study. Paper presented at: American Society of Hematology 61st Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL. Abstract 142.
  4. Venclexta (venetoclax tablets) [package insert]. North Chicago, IL: AbbVie Inc; 2019.
  5. Weisel K, Hopkins TG, Fecteau D, et al. Dreamm-3: a phase 3, open-label, randomized study to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy compared with pomalidomide plus low-dose dexamethasone (Pom/Dex) in participants with relapsed/refractory multiple myeloma (RRMM). Paper presented at: American Society of Hematology 61st Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL. Abstract 1900.
  6. Trudel S, Lendvai N, Popat R, et al. Antibody-drug conjugate, GSK2857916, in relapsed/refractory multiple myeloma: an update on safety and efficacy from dose expansion phase I study. Blood Cancer J. 2019;9(4):37. doi:10.1038/s41408-019-0196-6.
  7. Trudel S, Lendvai N, Popat R, et al. Targeting B-cell maturation antigen with GSK2857916 antibody-drug conjugate in relapsed or refractory multiple myeloma (BMA117159): a dose escalation and expansion phase 1 trial [published online November 12, 2018]. Lancet Oncol. 2018;19(12):1641-1653. doi:10.1016/S1470-2045(18)30576-X.

2 of 3

Cancer Summaries and Commentaries™: Report from Orlando on Advancements in Multiple Myeloma is a continuing medical education (CME)-certified activity designed to update physicians on data presented at the American Society of Hematology 61st Annual Meeting, held in December 2019, in Orlando, Florida. For each abstract, a text-based summary of the study background, design, key clinical data, and conclusions is accompanied by expert commentary from Shaji Kumar, MD, and Ajai Chari, MD, who provide insight into how clinicians can apply these findings to their clinical practice to improve patient care.

This second of 3 PER Pulse™ Recaps focuses on data reported in 2019 pertaining to novel treatment options in multiple myeloma (MM). Keep up with the ever-changing landscape of treatment modalities in this disease by exploring recently released research. Below are some highlights:

  • This study reports the results from a phase I dose-finding study (CC-93269-MM-001; NCT03486067) evaluating the investigational drug CC-93269 in patients with relapsed/ refractory multiple myeloma (RRMM).2
    • CC-93269 is a 2 + 1 B-cell maturation antigen (BMCA) T-cell engager (TCE) that has shown promising activity in preclinical studies. This drug binds to BCMA on MM cells, leading to T-cell activation, cytokine production, and subsequent target cell death.3
    • Data show a manageable safety profile and favorable survival benefit trends. The trial is ongoing, and enrollment continues in the dose escalation phase with a total goal of 120 participants.2
  • The phase III DREAMM-3 study (NCT04162210), initially planned to begin in late 2019, will evaluate the efficacy and safety of belantamab mafodotin monotherapy compared with pomalidomide and dexamethasone in patients with RRMM.3
    • Belantamab mafodotin, formerly known as GSK2857916, is a monoclonal anti-BCMA antibody that is afucosylated and conjugated to monomethyl auristatin F, a microtubule-disrupting agent.4
    • In the phase I study DREAMM-1/BMA117159 (NCT02064387), patients with RRMM receiving belantamab mafodotin monotherapy had a rapid, deep, and sustained response to treatment.5
  • A phase II study, (NCT02960555), evaluates the efficacy of isatuximab in the treatment of high-risk smoldering multiple myeloma (HRSMM).6
    • The current standard of care in this population is observation, even although more than half of patients with high-risk disease will progress within 2 years of diagnosis.7,8
    • Isatuximab is a monoclonal antibody that binds to CD38, a glycoprotein widely expressed on plasma cells and myeloma cells.9
    • Patients receiving isatuximab had high response rates, manageable adverse events, and favorable quality of life analyses.6

References

  1. Costa LJ, Wong SW, Bermúdez A, et al. First clinical study of the B-cell maturation antigen (BCMA) 2+1 T cell engager (TCE) CC-93269 in patients (pts) with relapsed/refractory multiple myeloma (RRMM): interim results of a phase 1 multicenter trial). Paper presented at: American Society of Hematology 61st Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL. Abstract 142.
  2. Cho SF, Anderson KC, Tai YT. Targeting B cell maturation antigen (BCMA) in multiple myeloma: potential uses of BCMA-based immunotherapy. Front Immunol. 2018;10(9):1821. doi:10.3389/fimmu.2018.01821.
  3. Weisel K, Hopkins TG, Fecteau D, et al. Dreamm-3: A phase 3, open-label, randomized study to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy compared with pomalidomide plus low-dose dexamethasone (Pom/Dex) in participants with relapsed/refractory multiple myeloma (RRMM). Paper presented at: American Society of Hematology 61st Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL. Abstract 1900.
  4. Trudel S, Lendvai N, Popat R, et al. Antibody-drug conjugate, GSK2857916, in relapsed/refractory multiple myeloma: an update on safety and efficacy from dose expansion phase I study. Blood Cancer J. 2019;9(4):37. doi:10.1038/s41408-019-0196-6.
  5. Trudel S, Lendvai N, Popat R, et al. Targeting B-cell maturation antigen with GSK2857916 antibody-drug conjugate in relapsed or refractory multiple myeloma (BMA117159): a dose escalation and expansion phase 1 trial [published online November 12, 2018]. Lancet Oncol. 2018;19(12):1641-1653. doi:10.1016/S1470-2045(18)30576-X.
  6. Manasanch EE, Jagannath S, Lee HC, et al. A multicenter phase II single arm trial of isatuximab in patients with high risk smoldering multiple myeloma (HRSMM). Presented at: American Society of Hematology 61st Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL. Abstract 3116.
  7. Mateos MV, Hernández MT, Giraldo P, et al. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. N Engl J Med. 2013;369(5):438-447. doi: 10.1056/NEJMoa1300439.
  8. Mateos MV, González-Calle V. Smoldering multiple myeloma: who and when to treat [published online June 23, 2017]. Clin Lymphoma Myeloma Leuk. 2017;17(11):716-722. doi: 10.1016/j.clml.2017.06.022.
  9. Trudel S. Incorporating isatuximab in the treatment of multiple myeloma [published online November 14, 2019]. Lancet. 2019;394(10214):2045-2047. doi: 10.1016/S0140-6736(19)32684-4.

3 of 3

Cancer Summaries and Commentaries™: Report from Orlando on Advancements in Multiple Myeloma is a continuing medical education (CME)-certified activity designed to update physicians on data presented at the American Society of Hematology 61st Annual Meeting, held in December 2019, in Orlando, Florida. For each abstract, a text-based summary of the study background, design, key clinical data, and conclusions is accompanied by expert commentary from Shaji Kumar, MD, and Ajai Chari, MD, who provide insight into how clinicians can apply these findings to their clinical practice to improve patient care.

This third of 3 PER Pulse™ Recaps focuses on data reported in 2019 pertaining to the novel agent isatuximab. Isatuximab is a monoclonal antibody that binds to CD38, a glycoprotein widely expressed on plasma cells and myeloma cells, resulting in cancer cell death via antibody-dependent and complement-dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis, and immune cell depletion.1 A Biologics License Application for isatuximab has been submitted and, as of late 2019, is under review by the Food and Drug Administration.2 Below are some highlights:

  • Data from the ICARIA-MM trial (NCT02990338) were used to assess the efficacy and safety of isatuximab in combination with pomalidomide and dexamethasone (Pd) versus Pd in elderly patients (≥75 years) with relapsed/refractory multiple myeloma (RRMM).3
    • ICARIA-MM was the first phase III trial to show improved and sustained progression free survival with the use of a monoclonal antibody in combination with a standard double therapy (Pd) in this difficult-to-treat population.4
    • Data from this report were consistent with the overall study population of the ICARIA-MM trial; patients receiving isatuximab saw improved survival benefit and response rates.3
  • An additional report analyzed data from ICARIA-MM to evaluate the correlation between depth of response and response kinetics with long-term outcomes.5
    • Study authors note that tumor responses were more frequent, quicker, and deeper for patients in the arm containing isatuximab.
  • A phase II study (NCT02960555) evaluates the efficacy of isatuximab in the treatment of high-risk smoldering multiple myeloma (HRSMM).6
    • The current standard of care in this population is observation, even though more than half of patients with high-risk disease will progress within 2 years of diagnosis.7,8
    • Patients receiving isatuximab had high response rates, manageable adverse events, and favorable quality of life analyses.6

References

  1. Trudel S. Incorporating isatuximab in the treatment of multiple myeloma [published online November 14, 2019]. Lancet. 2019;394(10214):2045-2047. doi: 10.1016/S0140-6736(19)32684-4.
  2. FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma [news release]. Paris, France: Sanofi; July 10, 2019. https://ml-eu.globenewswire.com/Resource/Download/14092c18-e19d-41e3-b455-27607ae995f7. Accessed January 7, 2020.
  3. Schjesvold FH, Richardson PG, Attal M, et al. Efficacy of isatuximab with pomalidomide and dexamethasone in elderly patients with relapsed/refractory multiple myeloma: Icaria-MM subgroup analysis. Paper presented at: American Society of Hematology 61st Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL. Abstract 1893.
  4. Richardson PG, Attal M, Campana F, et al. Isatuximab plus pomalidomide/dexamethasone versus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma: ICARIA phase III study design [published online December 22, 2017]. Future Oncol. 2018;14(11):1035-1047. doi: 10.2217/fon-2017-0616.
  5. Hulin C, Richardson PG, Attal M, et al. Depth of response and response kinetics in the Icaria-MM study of isatuximab with pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. Paper presented at: American Society of Hematology 61st Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL. Abstract 3185.
  6. Manasanch EE, Jagannath S, Lee HC, et al. A multicenter phase II single arm trial of isatuximab in patients with high risk smoldering multiple myeloma (HRSMM). Presented at: American Society of Hematology 61st Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL. Abstract 3116.
  7. Mateos MV, Hernández MT, Giraldo P, et al. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. N Engl J Med. 2013;369(5):438-447. doi: 10.1056/NEJMoa1300439.
  8. Mateos MV, González-Calle V. Smoldering multiple myeloma: who and when to treat [published online June 23, 2017]. Clin Lymphoma Myeloma Leuk. 2017;17(11):716-722. doi: 10.1016/j.clml.2017.06.022.

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