Consensus or Controversy? Documenting and Discussing Investigators’ Approaches to the Management of Relapsed/Refractory Multiple Myeloma

Faculty

Faculty

Melissa Alsina

MD

Moffitt Cancer Center, Tampa, Florida

Head, Myeloma Section, Bone Marrow Transplant and Cellular Immunotherapy Program

Faculty

Hans Lee

MD

Sarah Cannon Research Institute, Nashville, Tennessee

Director, Multiple Myeloma Research

Faculty

Paul G Richardson

MD

Dana-Farber Cancer Institute, Boston, Massachusetts

Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center

Harvard Medical School, Boston, Massachusetts

RJ Corman Professor of Medicine

Moderator

Sagar Lonial

MD, FACP, FASCO

Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia

Chair and Professor, Department of Hematology and Medical Oncology, Chief Medical Officer

Program Schedule — Central Time
6:30 PM – 7:00 PM — Registration and Dinner
7:00 PM – 9:00 PM — Educational Meeting

MODULE 1: Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory (R/R) Multiple Myeloma (MM)

• Research database documenting the effectiveness of idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel) for patients with heavily pretreated MM
• Published data from the Phase III KarMMa-3 and CARTITUDE-4 trials of ide-cel and cilta-cel, respectively, in earlier lines of treatment; overall survival findings from CARTITUDE-4
• FDA approvals of ide-cel and cilta-cel in earlier settings; identification of patients appropriate for CAR T-cell therapy and optimal sequencing with regard to other evidence-based approaches
• Spectrum, incidence and severity of acute and long-term toxicities with BCMA-directed CAR T-cell therapy in patients with MM; appropriate monitoring and management algorithms
• Rationale for the evaluation of CAR T-cell platforms with novel targets and/or manufacturing processes for R/R MM
• Early data with the GPRC5D-targeted CAR T-cell therapy arlocabtagene autoleucel for R/R MM; FDA regenerative medicine advanced therapy designation and ongoing evaluation
• Preliminary data and ongoing clinical research with other novel CAR T-cell platforms for R/R MM

MODULE 2: Integrating Bispecific Antibodies into the Management of R/R MM

• Similarities and differences in the cellular targets and mechanisms of action of the various bispecific antibodies used for MM
• Efficacy and safety findings leading to the FDA approvals of the BCMA-directed bispecific antibodies teclistamab, elranatamab and linvoseltamab as monotherapy for heavily pretreated MM
• Published findings from the Phase III MajesTEC-3 trial evaluating the combination of teclistamab and subcutaneous daratumumab for patients with R/R MM after ≥1 prior line of treatment 
• Emerging positive findings from the Phase III MajesTEC-9 and MagnetisMM-5 studies evaluating teclistamab and elranatamab, respectively, as monotherapy in earlier lines of treatment 
• Key efficacy and safety data with the GPRC5D-targeted bispecific antibody talquetamab for heavily pretreated disease
• Selection of appropriate candidates with R/R MM to receive BCMA-directed bispecific antibody monotherapy, talquetamab monotherapy and teclistamab/daratumumab; optimal incorporation regarding other available treatment options 
• Biological rationale for and published findings with the FcRH5-directed bispecific antibody cevostamab in the treatment of R/R MM
• Incidence and severity of cytokine release syndrome, neurotoxicity and other adverse events (AEs) with BCMA- and non-BCMA-targeted bispecific antibodies; optimal mitigation and management strategies

MODULE 3: Current Utility of Antibody-Drug Conjugates for MM

• Mechanism of action and structural components of belantamab mafodotin
• Historical efficacy and safety findings with belantamab mafodotin monotherapy for patients with R/R MM
• Key efficacy and safety data from the Phase III DREAMM-7 and DREAMM-8 trials evaluating belantamab mafodotin in combination with bortezomib/dexamethasone and with pomalidomide/dexamethasone, respectively, for patients who have received ≥1 prior line of therapy; overall survival findings from DREAMM-7
• FDA approval and current role of belantamab mafodotin/bortezomib/dexamethasone in the management of R/R MM
• Incidence, severity, mitigation and management of belantamab mafodotin-related AEs, including ocular toxicities

MODULE 4: Potential Role of Cereblon E3 Ligase Modulators (CELMoDs) in Therapy for MM

• Mechanism of action of CELMoDs; similarities and differences among iberdomide, mezigdomide and standard immunomodulatory drugs (IMiDs)
• Available data documenting the efficacy and safety of iberdomide and mezigdomide as monotherapy and combined with other systemic therapies for patients with R/R MM
• Emerging findings from the Phase III EXCALIBER-RRMM study indicating an improvement in minimal residual disease negativity rates with iberdomide/daratumumab/dexamethasone compared to daratumumab/bortezomib/dexamethasone for patients with R/R MM
• Emerging positive findings from the Phase III SUCCESSOR-2 trial evaluating mezigdomide/carfilzomib/dexa­methasone for R/R MM
• Other ongoing studies evaluating CELMoD-containing therapy for newly diagnosed and R/R MM; potential clinical role of CELMoDs
• Spectrum, frequency and severity of AEs observed with CELMoDs in published clinical studies; comparative tolerability profiles of iberdomide, mezigdomide and traditional IMiDs

Target Audience
This activity is intended for medical oncologists, hematologists, hematology-oncology fellows and other healthcare providers involved in the treatment of multiple myeloma.

Learning Objectives
Upon completion of this activity, participants should be able to

• Consider published research findings and other clinical factors in the best-practice sequencing of established and novel agents and regimens for patients with relapsed/refractory (R/R) multiple myeloma (MM).
• Evaluate published research findings to identify patients with R/R MM for whom treatment with chimeric antigen receptor T-cell therapy directed at B-cell maturation antigen (BCMA) should be considered and/or recommended.
• Assess available research data with BCMA- and non-BCMA-directed bispecific antibodies for MM in order to appropriately integrate these agents into clinical algorithms.
• Recall presented clinical research establishing the definitive efficacy of BCMA-directed antibody-drug conjugate therapy for patients with R/R MM.
• Analyze the mechanism of action of, published and emerging efficacy and safety findings with and ongoing research evaluating cereblon E3 ligase modulators to prepare for the potential clinical availability of these agents for patients with R/R MM.
• Implement a plan of care to recognize and manage class-effect and agent-specific toxicities associated with therapies commonly used in the care of patients with R/R MM.
• Recall available data with novel agents and strategies currently under investigation for R/R MM, and as applicable, discuss clinical trial participation with eligible patients.

CME Credit Form
A CME credit link will be given to each participant as part of the meeting course materials.

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FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr Alsina — Advisory Committees: Bristol Myers Squibb, Janssen Biotech Inc, Kite, A Gilead Company, Sanofi; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Janssen Biotech Inc, Pfizer Inc; Data and Safety Monitoring Boards/Committees: Bristol Myers Squibb. Dr Lee — Consulting Agreements (Paid to Institution): AbbVie Inc, Alexion Pharmaceuticals, Allogene Therapeutics, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, GSK, Janssen Biotech Inc, Legend Biotech, Medline, Pfizer Inc, Predicta Biosciences, Regeneron Pharmaceuticals Inc, Sanofi, Takeda Pharmaceuticals USA Inc; Consulting Agreements (Paid to Self): Alexion Pharmaceuticals, Allogene Therapeutics, Bristol Myers Squibb, GSK, Janssen Biotech Inc, Menarini Group, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi, Takeda Pharmaceuticals USA Inc; Contracted Research: AbbVie Inc, Alexion Pharmaceuticals, Amgen Inc, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, GSK, Janssen Biotech Inc, Menarini Group, Moderna, Regeneron Pharmaceuticals Inc, Takeda Pharmaceuticals USA Inc; Data and Safety Monitoring Boards/Committees: Allogene Therapeutics, Takeda Pharmaceuticals USA Inc. Dr Richardson — Consulting Agreements: Bristol Myers Squibb, Celgene Corporation, GSK, Karyopharm Therapeutics, Oncopeptides, Regeneron Pharmaceuticals Inc, Sanofi; Contracted Research: Oncopeptides.

MODERATOR
Dr Lonial — Advisory Committees and Consulting Agreements: AbbVie Inc, Amgen Inc, Bristol Myers Squibb, Genentech, a member of the Roche Group, GSK, Janssen Biotech Inc, Novartis, Pfizer Inc, Regeneron Pharmaceuticals Inc, Takeda Pharmaceuticals USA Inc; Boards of Directors: TG Therapeutics Inc; Contracted Research: Bristol Myers Squibb, Janssen Biotech Inc, Novartis, Takeda Pharmaceuticals USA Inc; Stock Options/Stock — Public Companies: TG Therapeutics Inc. 

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS
Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

Supporters
This activity is supported by educational grants from Bristol Myers Squibb, Genentech, a member of the Roche Group, and GSK.

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