Cases from the Community: Investigators Discuss the Optimal Management of Chronic Lymphocytic Leukemia

Faculty

Faculty

John N Allan

MD

Weill Cornell Medicine, New York, New York

Associate Professor of Clinical Medicine

Faculty

Bita Fakhri

MD, MPH

Stanford University School of Medicine, Stanford, California

Associate Professor of Medicine (Hematology)

Faculty

Shuo Ma

MD, PhD

Robert H Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois

Professor of Medicine, Division of Hematology-Oncology, Department of Medicine

Moderator

Jeremy S Abramson

MD, MMSc

Massachusetts General Hospital, Boston, Massachusetts

Director, Center for Lymphoma

Harvard Medical School, Boston, Massachusetts

Professor of Medicine

Faculty

Mazyar Shadman

MD, MPH

Fred Hutchinson Cancer Center and University of Washington, Seattle, Washington

Professor, Innovators Network Endowed Chair, Deputy Chief Medical Officer, Medical Director, Cellular Immunotherapy, Professor, Clinical Research Division

Program Schedule — Central Time
6:00 PM – 6:30 PM — Registration and Dinner
6:30 PM – 8:30 PM — Educational Meeting

MODULE 1: Current and Future Role of Continuous Bruton Tyrosine Kinase (BTK) Inhibitor Therapy for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

• Clinical, biological and practical factors in the selection of front-line therapy for patients with CLL requiring treatment
• Long-term findings from Phase III studies assessing ibrutinib-, acalabrutinib- and zanubrutinib-based therapy for treatment-naïve and relapsed/refractory (R/R) CLL; application in current up-front decision-making
• Pharmacological similarities and differences between covalent and noncovalent BTK inhibitors
• Key findings from the Phase III BRUIN CLL-314 study of pirtobrutinib versus ibrutinib for patients with treatment-naïve or previously treated, BTK inhibitor-naïve CLL
• Published data with pirtobrutinib versus bendamustine/rituximab for patients with treatment-naïve CLL without del(17p) in the Phase III BRUIN CLL-313 trial
• Potential clinical role of pirtobrutinib in therapy for newly diagnosed CLL

MODULE 2: Available and Emerging Approaches to Time-Limited Therapy for Treatment-Naïve CLL

• Long-term data with up-front venetoclax/obinutuzumab for CLL
• Mechanistic rationale for combining BTK inhibitors and venetoclax with and without anti-CD20 antibodies for CLL
• Published findings from the Phase III AMPLIFY trial of fixed-duration acalabrutinib in combination with venetoclax with or without obinutuzumab for previously untreated CLL
• Recent FDA approval of fixed-duration acalabrutinib and venetoclax for patients with treatment-naïve CLL; integration into current clinical algorithms
• Early data with zanubrutinib in combination with Bcl-2 inhibitors, such as venetoclax or sonrotoclax, with or without an anti-CD20 antibody, for treatment-naïve CLL
• Efficacy and safety findings from and clinical implications of the Phase III CLL17 trial evaluating fixed-duration versus continuous targeted treatment for previously untreated CLL

MODULE 3: Optimal Management of Adverse Events (AEs) with BTK and Bcl-2 Inhibitors; Considerations for Special Patient Populations

• Relevant patient comorbidities, such as hypertension, preexisting cardiac arrhythmias, chronic kidney disease and chronic migraines, and concomitant medications that might influence the choice of therapy for CLL
• Spectrum, frequency and severity of cardiovascular AEs with covalent and noncovalent BTK inhibitors; optimal monitoring and management protocols
• Incidence and management of noncardiovascular AEs associated with covalent and noncovalent BTK inhibitors
• Frequency of tumor lysis syndrome and other common AEs reported with venetoclax for CLL, such as cytopenias, infections and gastrointestinal disorders; monitoring, prophylaxis and management protocols
• Incidence, severity and management of clinically relevant toxicities encountered when combining BTK and Bcl-2 inhibitors with or without anti-CD20 antibodies

MODULE 4: Selection and Sequencing of Therapy for R/R CLL

• Clinical and biological factors guiding decision-making for patients with R/R CLL; impact of the evolving up-front CLL treatment paradigm on the management of R/R disease
• Long-term follow-up from Phase III trials evaluating covalent BTK inhibitors and Bcl-2 inhibitors for patients with R/R CLL; current role of rechallenge with an agent or class of agents received in a prior line of therapy
• Published findings from key trials, such as BRUIN and BRUIN CLL-321, supporting the use of pirtobrutinib for patients with R/R CLL
• Emerging positive findings from the Phase III BRUIN CLL-322 trial of pirtobrutinib in combination with venetoclax and rituximab versus venetoclax and rituximab for patients with R/R CLL
• Available and emerging efficacy and safety data with and ongoing evaluation of other noncovalent BTK inhibitors, such as nemtabrutinib and rocbrutinib, for R/R and treatment-naïve CLL

MODULE 5: Other Novel Strategies for CLL

• Biological rationale for the evaluation of CAR T-cell therapy in CLL
• Published efficacy and safety findings with lisocabtagene maraleucel (liso-cel) for R/R CLL from the Phase I/II TRANSCEND CLL 004 trial
• FDA approval of liso-cel for CLL previously treated with a BTK inhibitor and a Bcl-2 inhibitor; current clinical role and optimal patient selection
• Early antitumor activity and safety data with bispecific antibodies for R/R CLL and CLL with Richter’s syndrome
• Rationale for the design of the ongoing Phase III SOUNDTRACK-C1 study of the CD19 x CD3 bispecific T-cell engager surovatamig as consolidation therapy for patients with IGHV-unmutated CLL
• Preliminary data with and ongoing Phase III trials of other promising novel agents and strategies, such as sonrotoclax and BTK degraders, for patients with CLL  

Target Audience
This activity is intended for medical oncologists, hematologists, hematology-oncology fellows and other healthcare providers involved in the treatment of chronic lymphocytic leukemia (CLL).

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

• Individualize the selection of systemic therapy for patients with newly diagnosed CLL, considering new research findings, clinical presentation, biomarker profile, coexisting medical conditions and patient preferences.
• Review the similarities and differences between covalent and noncovalent Bruton tyrosine kinase (BTK) inhibitors, and assess the implications for the efficacy and tolerability of these agents.
• Evaluate available and emerging Phase III data demonstrating the efficacy of BTK inhibitors as first-line therapy for CLL, and use this information to counsel patients regarding front-line treatment options.
• Discuss available clinical research demonstrating the efficacy and safety of noncovalent BTK inhibitors for newly diagnosed and relapsed/refractory CLL, and identify patients appropriate for treatment with these agents.
• Appreciate the scientific rationale for the investigation of combined BTK and Bcl-2 inhibition, and review recently presented and emerging data with and the current and potential role of this strategy for patients with newly diagnosed and relapsed/refractory CLL.
• Evaluate the biological rationale for the investigation of CD19-directed chimeric antigen receptor T-cell therapy for CLL, and identify patients for whom treatment with this novel therapeutic strategy would be appropriate.
• Recall available data with novel agents and combination strategies currently under investigation for CLL, 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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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the provider or grantors.

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

Dr Allan — Advisory Committees: NeoGenomics; Consulting Agreements: AbbVie Inc, Adaptive Biotechnologies Corporation, ADC Therapeutics, AstraZeneca Pharmaceuticals LP, BeOne, Genentech, a member of the Roche Group, Janssen Biotech Inc, Lilly, Pharmacyclics LLC, an AbbVie Company; Contracted Research: Adaptive Biotechnologies Corporation, BeOne, Bristol Myers Squibb, Genentech, a member of the Roche Group; Data and Safety Monitoring Boards/Committees: Merck; Speakers Bureaus: AbbVie Inc, BeOne. Dr Fakhri — Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Pharmacyclics LLC, an AbbVie Company; Contracted Research: AbbVie Inc, BeOne, Genmab US Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company. Dr Ma — Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Genentech, a member of the Roche Group, Lilly; Consulting Agreements: AbbVie Inc; Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Carna Biosciences, Juno Therapeutics, a Celgene Company, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Nurix Therapeutics Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, BeOne, Lilly. Dr Shadman — Advisory Committees and Consulting Agreements: AbbVie Inc, ADC Therapeutics, Ascentage Pharma, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Fate Therapeutics, Genentech, a member of the Roche Group, Genmab US Inc, Incyte Corporation, Janssen Biotech Inc, Kite, A Gilead Company, Lilly, Merck, MorphoSys, Nurix Therapeutics Inc, Pfizer Inc, Pierre Fabre; Contracted Research: AstraZeneca Pharmaceuticals LP, BeOne, Genentech, a member of the Roche Group, Genmab US Inc, Incyte Corporation, Janssen Biotech Inc, Merck, MorphoSys, Nurix Therapeutics Inc, Sana Biotechnology; Stock OPTIONS — Private Companies: Koi Biotherapeutics Inc; Nonrelevant Financial Relationships: Bristol Myers Squibb (spouse employment).

MODERATOR
Dr Abramson — Consulting Agreements: AbbVie Inc, ADC Therapeutics, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Celgene Corporation, Foresight Diagnostics, a wholly-owned subsidiary of Natera Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Interius BioTherapeutics, Miltenyi Biotec, Novartis, Roche Laboratories Inc, Seagen Inc; Contracted Research: Bristol Myers Squibb, Celgene Corporation, Cellectis, Genentech, a member of the Roche Group, Merck, Mustang Bio, Regeneron Pharmaceuticals Inc, Seagen Inc, Takeda Pharmaceuticals USA 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 AstraZeneca Pharmaceuticals LP and Lilly.

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