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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.

Acknowledgment of Commercial Support

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

Cancer Summaries and Commentaries™: Report from San Diego on Advancements in Multiple Myeloma


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

Activity Overview

This activity, Cancer Summaries and Commentaries™: Report from San Diego on Advancements in Multiple Myeloma, will provide you with clinically important information about the latest developments in the management of patients with multiple myeloma (MM). Listen to experts as they describe the studies below, and share their insights regarding how these results will impact the care of your patients with MM in the future. In R/R MM, you will explore the treatment of diverse classes of investigational drugs, including a selective inhibitor of nuclear export compound, a Bcl-2 inhibitor, chimeric antigen receptor T-cell therapy, and bispecific T-cell engager antibody therapy. In patients with newly diagnosed disease that is ineligible for transplant, you’ll learn how targeted agents are being combined with existing therapies to improve outcomes. Finally, in patients with newly diagnosed disease that is eligible for transplant, abstracts examine novel regimens in both the induction and consolidation phases. This activity will help you begin now to sharpen your clinical skills for the care of your patients with MM.

Benefits of Completing Activity:

Benefits of participating in the online activity, Cancer Summaries and Commentaries™: Report from San Diego on Advancements in Multiple Myeloma:

  • Familiarize yourself with emerging novel approaches to the treatment of MM, including selective inhibition of nuclear export, chimeric antigen receptor T-cell therapy, and bispecific T-cell engager antibody therapy
  • Improve your understanding of the latest clinical trial data in MM
  • Increase your ability to incorporate practice-changing data into the management of your patients with MM

Acknowledgement of Commercial Support

This activity is supported by educational grants from Celgene Corporation, 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 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 and hematologists who treat patients with MM. Fellows, nurses, nurse practitioners, physician assistants, and other healthcare professionals interested in the management of patients with MM are also invited to participate.

Learning Objectives

Upon successful completion 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 MM
  • Elaborate on key efficacy and safety results concerning the use of novel strategies in patients with MM and how to incorporate them into practice
  • Place presented clinical trial evidence into the context of evolving treatment paradigms and strategies in the management of patients with MM

Faculty, Staff, and Planners' Disclosures

Faculty

Jesús G. Berdeja, MD
Director, Multiple Myeloma Research
Senior Investigator, Hematologic Malignancies
Sarah Cannon Research Institute
Nashville, TN
 

Disclosures: Grant/Research Support: AbbVie, Amgen, Bluebird, BMS, Celgene, Genentech, Glenmark, Janssen, Novartis, Poseida, Sanofi, Takeda, Teva; Consultant: Celgene, Takeda, Bluebird, Karyopharm, Novartis, Servier, Kite, Sanofi, Prothena

Ajai Chari, MD
Associate Professor
Medicine, Hematology, and Medical Oncology
The Mount Sinai Hospital
New York, NY
 

Disclosures: Grant/Research Support: Takeda, Celgene, Novartis, Janssen; Consultant: Takeda, Celgene, Novartis, Janssen, Bristol-Myers Squibb

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™ Recaps

PER Pulse™ Recap
1 of 3
 
Investigational Therapies for Relapsed/Refractory Multiple Myeloma 
 
The online continuing medical education activity, Cancer Summaries and Commentaries™: Report from San Diego on Advancements in Multiple Myeloma, featured 2 renowned experts in multiple myeloma (MM) who provided commentary on the clinical importance of 9 MM abstracts presented at a major oncology meeting held in San Diego, California, in December 2018. They were Jesús G. Berdeja, MD, Director of Multiple Myeloma Research and Senior Investigator of Hematologic Malignancies at the Sarah Cannon Research Institute in Nashville, Tennessee; and Ajai Chari, MD, Associate Professor of Medicine, Hematology, and Medical Oncology at The Mount Sinai Hospital in New York, New York. Dr. Berdeja and Dr. Chari examined abstracts focused on investigational therapies both for patients with relapsed/refractory (R/R) disease and those with newly diagnosed disease.
 
This first of 3 PER Pulse™ Recaps reviews investigational therapies for patients with R/R MM. Below are some highlights from the activity, featuring audio clips from Dr. Berdeja and Dr. Chari:

  • The STORM trial is the pivotal trial of oral selinexor, a selective inhibitor of nuclear export (SINE) that inactivates exportin 1 (XPO1), used to treat patients (in Part 2 of the study) with penta-refractory MM (ie, refractory to ≥1 proteasome inhibitor, to ≥1 immunomodulatory imide drug, to daratumumab, to a glucocorticoid, and to their last therapy). The overall response rate was 26.2%, with 6.5% of patients having very good partial response or better, including 2 stringent complete responses. Median duration of response was 4.4 months, median progression-free survival was 3.7 months, and median overall survival was 8.0 months.
    • Dr. Berdeja called these data impressive and predicted that they would lead to approval of selinexor in this setting. However, he did point out the toxicity profile, focusing primarily on a discussion of the gastrointestinal toxicities of anorexia and weight loss. While he called these toxicities manageable, he called for aggressive multiagent interventions, such as olanzapine, steroids, and antiemetics. He stated his belief that selinexor may be most useful in combination with approved therapies, as is being explored in the STOMP trial, because the decreased dosing schedule for selinexor appears to improve the safety profile.
    • Dr. Chari also mentioned the toxicities of selinexor but pointed out that they were typically manageable with dose interruptions and dose reductions. He also shared his belief that the single-agent activity of selinexor gives it an advantage over other agents like panobinostat; however, as did Dr. Berdeja, he suggested it will ultimately be used as part of combination therapy.
  • Dr. Berdeja and Dr. Chari also commented on some additional R/R MM abstracts:
    • A phase II study of venetoclax + carfilzomib and dexamethasone
    • A phase I study of LCAR-B38M, a chimeric antigen receptor (CAR) T-cell therapy
    • A phase I study of bb21217, another CAR T-cell therapy
    • A phase I study of AMG 420, a bispecific T-cell engager antibody construct


PER Pulse™ Recap
2 of 3
 
Chimeric Antigen Receptor T-Cell Therapy for Relapsed/Refractory Multiple Myeloma
 
The online continuing medical education activity, Cancer Summaries and Commentaries™: Report from San Diego on Advancements in Multiple Myeloma, featured 2 renowned experts in multiple myeloma (MM) who provided commentary on the clinical importance of 9 MM abstracts presented at a major oncology meeting held in San Diego, California, in December 2018. They were Jesús G. Berdeja, MD, Director of Multiple Myeloma Research and Senior Investigator of Hematologic Malignancies at the Sarah Cannon Research Institute in Nashville, Tennessee; and Ajai Chari, MD, Associate Professor of Medicine, Hematology, and Medical Oncology at The Mount Sinai Hospital in New York, New York. Dr. Berdeja and Dr. Chari examined abstracts focused on investigational therapies both for patients with relapsed/refractory (R/R) disease and those with newly diagnosed disease.
 
This second of 3 PER Pulse™ Recaps reviews chimeric antigen receptor (CAR) T-cell therapies for patients with R/R disease. Below are some highlights from the activity, featuring audio clips from Dr. Berdeja and Dr. Chari:

  • LEGEND-2 is a phase I, single-arm study evaluating the bispecific CAR T-cell therapy LCAR-B38M, which is directed against B-cell maturation antigen (BCMA), in patients with R/R MM. The overall response rate reported among the 57 patients was 88%, with complete response (CR) achieved by 74% of patients. Median duration of response was 16 months overall and 22 months for patients who achieved CR. Median progression-free survival (PFS) overall was 15 months and 24 months for patients who achieved CR. Median overall survival was not reached.
    • Dr. Berdeja commented on how gratifying it was to see such promising treatment-free intervals with patients receiving CAR T-cell therapy, but he cautioned that there is tremendous treatment selection bias in any CAR T-cell therapy trial, bringing the generalizability of the results into question. Therefore, he proposed that these trials present standardized information regarding the number of patients who signed consent, who had cells collected, who received bridging chemotherapy, and ultimately who received T-cell infusions.
    • Dr. Chari commented on the impressive median PFS of 15 months while pointing out that this patient population was not heavily pretreated and often had not received therapies such as pomalidomide and daratumumab, which are considered standard in the United States. He also mentioned that the toxicity profile was favorable, with cytokine release syndrome (CRS) being primarily grade 1/2 and neurotoxicity being uncommon.
  • bb21217 is another CAR T-cell therapy directed against BCMA. CRB-402 is an ongoing, multicenter, phase I, dose-escalation trial of bb21217 in approximately 50 patients with R/R MM who have received ≥3 prior regimens, including a proteasome inhibitor and an immunomodulatory imide drug, or who are double-refractory. Of the 8 patients receiving bb21217 thus far, 5 developed CRS that improved with treatment. Six of 7 evaluable patients have demonstrated clinical response, with 1 stringent CR and 3 very good partial responses.
    • Both Dr. Berdeja and Dr. Chari focused their comments on the need for CAR T-cell therapies to reduce the number of patients who relapse after treatment; Dr. Berdeja mentioned that, unlike in other malignancies, CAR T-cell therapies in MM do not produce a tail on the survival curve, meaning patients continue to relapse over time. One explanation for this phenomenon is a lack of CAR T-cell persistence, a problem that is being addressed by bb21217, as a next-generation agent of bb2121 designed to improve persistence and efficacy. Dr. Chari called the data from the bb21217 trial tantalizing but reminded participants that additional follow-up will be required to further quantify the promise of this approach.

 
PER Pulse™ Recap
3 of 3
 
Treatment of Patients With Newly Diagnosed Multiple Myeloma Ineligible for Transplant
 
The online continuing medical education activity, Cancer Summaries and Commentaries™: Report from San Diego on Advancements in Multiple Myeloma, featured 2 renowned experts in multiple myeloma (MM) who provided commentary on the clinical importance of 9 MM abstracts presented at a major oncology meeting held in San Diego, California, in December 2018. They were Jesús G. Berdeja, MD, Director of Multiple Myeloma Research and Senior Investigator of Hematologic Malignancies at the Sarah Cannon Research Institute in Nashville, Tennessee; and Ajai Chari, MD, Associate Professor of Medicine, Hematology, and Medical Oncology at The Mount Sinai Hospital in New York, New York. Dr. Berdeja and Dr. Chari examined abstracts focused on investigational therapies both for patients with relapsed/refractory disease and those with newly diagnosed disease.
 
This third of 3 PER Pulse™ Recaps reviews abstracts focused on newly diagnosed MM (NDMM) in patients ineligible for transplant. Below are some highlights from the activity, featuring audio clips from Dr. Berdeja and Dr. Chari:

  • MAIA is an international phase III study of daratumumab added to lenalidomide and dexamethasone (D-Rd vs Rd) for the treatment of 737 patients with transplant-ineligible NDMM. For the primary endpoint of progression-free survival (PFS), the hazard ratio (HR) was 0.55 (P <.0001), with a median PFS for the Rd arm of 31.9 months and not reached for the D-Rd arm. Adding daratumumab to Rd also resulted in deeper responses, with a significantly improved complete response (CR) or better rate (47.6% vs 24.7%, respectively; P <.0001) and very good partial response or better rate (79.3% vs 53.1%, respectively; P <.0001). The HR for overall survival was 0.78 (95% CI, 0.56-1.1).
    • Dr. Chari stated that he was looking forward to having another option aside from bortezomib, lenalidomide, and dexamethasone (VRd) to give his elderly patients, because twice-weekly bortezomib often has poor tolerability. He did caution that physicians needed to be aware of the risk, management, and prophylaxis of infections because of the increased incidence of neutropenia with daratumumab.
    • Dr. Berdeja predicted that these results will change the standard of care in the United States. He mentioned that daratumumab was associated with an increased depth of responses compared with Rd alone.
  • A phase I study of isatuximab, an anti-CD38 monoclonal antibody, in combination with VRd, was conducted in patients with transplant-ineligible NDMM. Initial data from 22 patients were presented, with 3 patients discontinuing treatment and 2 patients experiencing treatment-related serious adverse events. In 14 efficacy-evaluable patients, the overall response rate was 93%, with 1 stringent CR and 1 CR. At the end of 4 induction cycles, 7 of these 9 patients had a residual M-component below 0.2. Five of 13 patients (38.5%) achieved minimal residual disease–negative status.
    • Dr. Chari called isatuximab + VRd a very active regimen and impressive, even in a transplant-ineligible population. He reminded participants that isatuximab has an advantage over daratumumab in its shorter infusion time, at least before the subcutaneous formulation of daratumumab is approved.
    • Dr. Berdeja pointed out the favorable safety profile associated with adding isatuximab to VRd, even in an elderly population, as well as the achievement of very high and very deep responses. He concluded by saying that these data, in conjunction with data from the MAIA trial, are moving the standard of care toward the addition of monoclonal antibodies to a proteasome inhibitor and immunomodulatory imide drug in patients with transplant-ineligible NDMM.






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