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

Assistant Professor of Medicine (Hematology)

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

Moderator

Jeremy S Abramson

MD, MMSc

Massachusetts General Hospital, Boston, Massachusetts

Director, Center for Lymphoma

Harvard Medical School, Boston, Massachusetts

Professor of Medicine

Additional faculty to be announced.

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
• Emerging positive 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
• Emerging data documenting an efficacy advantage 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
• Anticipated read-out and potential 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) Associated 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, 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-32, supporting the use of pirtobrutinib 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
• Similarities and differences between sonrotoclax and venetoclax; early data with sonrotoclax in combination with an anti-CD20 antibody for R/R and treatment-naïve CLL and ongoing Phase III evaluation for R/R disease

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
• Optimal approaches to bridging therapy and other practical and safety considerations with CAR T-cell therapy
• Early antitumor-activity and safety data with bispecific antibodies for R/R CLL and CLL with Richter’s syndrome
• Mechanistic similarities and differences between BTK degraders and BTK inhibitors; implications for efficacy in patients with BTK resistance mutations
• Updated safety and efficacy of the BTK degrader BGB-16673 for patients with heavily pretreated CLL in the Phase I CaDAnCe-101 study; FDA fast track designation and potential clinical role

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
To be announced.

MODERATOR
To be announced.

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
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Supporters
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Lilly.

Hilton Chicago
720 South Michigan Avenue
Chicago, IL 60605
Phone: (312) 922-4400

Meeting Room
Continental Room B (Lobby Level)

Directions
The Hilton Chicago hotel is located just 5 minutes (2.5 miles) north of the McCormick Place convention center, where the ASCO Annual Meeting is taking place.