Consensus or Controversy? Documenting and Discussing Investigators’ Approaches to the Management of Chronic Lymphocytic Leukemia

Join us on Friday, December 11^th from 7:30 AM to 9:30 AM central time (8:30 AM to 10:30 AM eastern time).

Module 1: Front-Line Therapy for Patients with Chronic Lymphocytic Leukemia (CLL) without High-Risk Features

• Clinical, biological and practical factors in the selection of front-line therapy for patients with CLL requiring treatment
• Extended follow-up from Phase III studies assessing ibrutinib-, acalabrutinib- and zanubrutinib-based therapy for treatment-naïve and relapsed/refractory (R/R) CLL; outcomes for patients without high-risk features and application in current up-front decision-making
• Long-term data supporting the approval of fixed-duration venetoclax/obinutuzumab as up-front treatment for CLL
• Published efficacy and safety data from the Phase III AMPLIFY trial of fixed-duration acalabrutinib in combination with venetoclax with or without obinutuzumab for previously untreated CLL with no del(17p) or TP53 mutation; FDA approval of acalabrutinib/venetoclax in this setting
• Early data with zanubrutinib in combination with a Bcl-2 inhibitor, such as venetoclax or sonrotoclax, with or without an anti-CD20 antibody for previously untreated CLL; efficacy documented among patients with standard-risk disease and current nonresearch role in that population
• Phase III CLL17 trial evaluating fixed-duration versus continuous targeted up-front treatment: Implications for the selection of therapy for patients without high-risk features

Module 2: Initial Treatment for High-Risk CLL

• Incidence and appropriate identification of markers of poor prognosis in patients with CLL, such as 17p deletion, TP53 mutation and unmutated IGHV
• Outcomes documented with continuous Bruton tyrosine kinase (BTK) inhibitor therapy among patients with treatment-naïve high-risk CLL
• Current role, if any, of time-limited combination approaches, such as venetoclax/obinutuzumab or BTK inhibitor/venetoclax with or without an anti-CD20 antibody, as initial therapy for patients with CLL and high-risk features
• Potential utility of minimal residual disease testing to establish the optimal duration of front-line therapy for patients with CLL and a high risk of recurrence
• Ongoing Phase III trials evaluating BTK inhibitor/Bcl-2 inhibitor combinations enrolling patients with newly diagnosed CLL with high-risk features

Module 3: Available Data with and Role of Noncovalent BTK Inhibitor Therapy for Newly Diagnosed CLL

• Mechanistic and pharmacologic similarities and differences between noncovalent and covalent BTK inhibitors; implications for efficacy and tolerability
• 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
• Efficacy advantage documented with pirtobrutinib in comparison to bendamustine/rituximab for patients with treatment-naïve CLL without del(17p) in the Phase III BRUIN CLL-313 trial; recent FDA approval of pirtobrutinib for previously untreated CLL without del(17p)
• Potential clinical role of pirtobrutinib in the management of newly diagnosed CLL; implications for therapeutic sequencing and future practice
• Early data with and ongoing trials of pirtobrutinib in combination with other systemic therapies, such as venetoclax with or without obinutuzumab, for newly diagnosed CLL
• Tolerability profile of pirtobrutinib; optimal approaches for monitoring for and managing common toxicities

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

• 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
• Long-term efficacy and safety findings with and current clinical utility of pirtobrutinib for patients with R/R CLL
• Design, eligibility criteria and primary and secondary endpoints for the Phase III BRUIN CLL-322 trial comparing fixed-duration pirtobrutinib/venetoclax/rituximab to venetoclax/rituximab for previously treated CLL
• Recently published results with pirtobrutinib/venetoclax/rituximab in the BRUIN CLL-322 trial; implications for clinical management
• Published efficacy and safety findings with and optimal patient selection for chimeric antigen receptor T-cell therapy with lisocabtagene maraleucel for R/R CLL

Module 5: Novel Agents in Clinical Development for CLL

• Mechanistic similarities and differences between the novel noncovalent BTK inhibitor nemtabrutinib and currently available covalent and noncovalent BTK inhibitors for CLL; implications for efficacy and tolerability
• Available efficacy and safety data with and ongoing Phase III evaluations of nemtabrutinib 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 treatment-naïve CLL and ongoing Phase III evaluations for R/R and treatment-naïve CLL
• Mechanistic similarities and differences between BTK chimeric degradation activation compounds (CDACs) and BTK inhibitors; implications for the efficacy of these strategies for patients with BTK resistance mutations
• Updated safety and efficacy of the BTK CDAC tacabrutideg (BGB-16673) for patients with heavily pretreated CLL in the Phase I CaDAnCe-101 study; FDA fast track designation, ongoing Phase III investigation and potential clinical role
• Other promising agents and strategies under investigation for CLL, such as epcoritamab, surovatamig and rocbrutinib

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

Learning Objectives
At the conclusion of this activity, participants should be able to

• Recognize the prognostic and clinical significance of various biomarkers (eg, del[17p], TP53 mutations, IGHV gene rearrangements) in CLL, and refine molecular testing algorithms for patients with newly diagnosed disease. 
• Individualize the selection of systemic therapy for newly diagnosed CLL, considering risk profile, clinical presentation, 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 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. 
• Understand published research findings with Bcl-2 inhibitors in combination with anti-CD20 antibodies as first-line treatment for CLL to effectively inform patients about the risks and benefits of this novel treatment strategy. 
• Appreciate the scientific rationale for the investigation of combined BTK and Bcl-2 inhibition, and review available data with this strategy in patients with newly diagnosed and relapsed/refractory (R/R) CLL. 
• Appraise clinical investigator best practices for various R/R CLL management situations, and use this information to facilitate improved clinical decision-making. 
• Recall available and emerging data with novel agents and combination strategies currently under investigation for CLL and, where applicable, discuss clinical trial participation with eligible patients.  

CE Credit
CME credit information will be provided to each participant at the conclusion of the activity.

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Credit Designation Statement
Research To Practice designates this live activity for a maximum of 2 AMA PRA Category 1 Credits^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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Unlabeled/Unapproved Uses Notice
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.

Content Validation and Disclosures
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships will have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. Faculty disclosures to be announced.

FACULTY — Dr Munir has no relevant financial relationships to disclose. The following faculty reported relevant financial relationships with ineligible entities:

Dr Eyre — Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Autolus, BeOne, Bristol Myers Squibb, Galapagos NV, Gilead Sciences Inc, Incyte Corporation, Janssen Biotech Inc, Kite, A Gilead Company, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Nurix Therapeutics Inc, Roche Laboratories Inc, Sobi; Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Autolus, BeOne, Bristol Myers Squibb, Galapagos NV, Gilead Sciences Inc, Incyte Corporation, Janssen Biotech Inc, Kite, A Gilead Company, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Nurix Therapeutics Inc, Roche Laboratories Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, BeOne; Speakers Bureaus: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Gilead Sciences Inc, Incyte Corporation, Janssen Biotech Inc, Kite, A Gilead Company, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Roche Laboratories Inc. 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). Dr Wierda — Consulting/Advisory Boards, No Compensation: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Intellisphere, Johnson & Johnson, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company; Contracted Research: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, BeOne, Bristol Myers Squibb, Genentech, a member of the Roche Group, Gilead Sciences Inc, Janssen Biotech Inc, Juno Therapeutics, a Bristol Myers Squibb Company, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Nurix Therapeutics Inc, Pharmacyclics LLC, an AbbVie Company; Nonrelevant Financial and Nonfinancial Relationships: National Comprehensive Cancer Network (Chair, CLL), Supported by the NIH/NCI under award number P30 CA016672 and used MD Anderson Cancer Center Support Grant (CCSG) shared resources, Wiley China (consulting/advisory board, no compensation).

MODERATOR
Dr Nakhoda — Contracted Research: AstraZeneca Pharmaceuticals LP, BeOne, Genentech, a member of the Roche Group.

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, BeOne, and Lilly.

Sheraton New Orleans Hotel
500 Canal Street
New Orleans, LA 70130
Hotel Phone: (504) 525-2500

Meeting Room
Napoleon Ballroom C/D — Third floor

Directions
The Sheraton New Orleans Hotel is located 0.9 miles (15-minute walk) from the New Orleans Ernest N Morial Convention Center, where the 2026 ASH Annual Meeting is taking place.

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