Friday, December 8, 2023, 3:15 PM – 5:15 PM PT (6:15 PM – 8:15 PM ET)

Beyond the Guidelines: Clinical Investigator Perspectives on the Management of Chronic Lymphocytic Leukemia (Part 3 of a 4-Part Series)

A CME Friday Satellite Symposium and Virtual Event Preceding the 65th ASH Annual Meeting

Location
Omni San Diego Hotel
675 L Street
San Diego, CA 92101
Phone: (619) 231-6664

Program Schedule — Pacific Time
2:45 PM – 3:15 PM — Registration and Light Snacks
3:15 PM – 5:15 PM — Educational Meeting

Meeting Room
Grand Ballroom (Level 2)


This event will also be webcast live.
Please see Registration tab for details.
There is no registration fee for this event. For the in-person symposium in San Diego, preregistration is required as seating is limited.  
 
Faculty
Farrukh T Awan, MD
Professor of Internal Medicine
Director of Lymphoid Malignancies Program
Harold C Simmons Comprehensive Cancer Center
The University of Texas
Southwestern Medical Center
Dallas, Texas

Matthew S Davids, MD, MMSc
Associate Professor of Medicine
Harvard Medical School
Director of Clinical Research
Division of Lymphoma
Dana-Farber Cancer Institute
Boston, Massachusetts

Stephen J Schuster, MD
Director, Lymphoma Program and Lymphoma Translational Research
Robert and Margarita Louis-Dreyfus Professor
in CLL and Lymphoma
Professor of Medicine, Hematology/Oncology
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania


William G Wierda, MD, PhD
Jane and John Justin Distinguished Chair in
Leukemia Research in Honor of Dr Elihu Estey
Section Chief, Chronic Lymphocytic Leukemia
Center Medical Director
Department of Leukemia
Division of Cancer Medicine
Executive Medical Director
Inpatient Medical Services
The University of Texas
MD Anderson Cancer Center
Houston, Texas

Jennifer Woyach, MD
Professor
Division of Hematology
Department of Internal Medicine
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio

Moderator
Neil Love, MD
Research To Practice
Miami, Florida


This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, and Lilly.
Program Schedule — Pacific Time
2:45 PM – 3:15 PM — Registration and Light Snacks
3:15 PM – 5:15 PM — Educational Meeting

MODULE 1: Front-Line Treatment for Chronic Lymphocytic Leukemia (CLL) — Dr Wierda

  • Threshold for initiating active therapy for CLL; implications of recently presented findings from the Phase III CLL12 study
  • Clinical and biological factors in the selection of first-line therapy for patients with CLL requiring active therapy
  • Long-term follow-up from Phase III studies assessing ibrutinib-, acalabrutinib- and zanubrutinib-based therapy for patients with previously untreated CLL
  • Outcomes observed with venetoclax-based up-front therapy for older/unfit and fit patients with treatment-naïve CLL
  • Implications, if any, of minimal residual disease (MRD) assessment for determining the duration of venetoclax-based up-front therapy; current and future role of MRD in clinical decision-making

MODULE 2: Novel Strategies Combining Bruton Tyrosine Kinase (BTK) and Bcl-2 Inhibitors in the Treatment of CLL — Dr Davids

  • Mechanistic rationale for combining BTK and Bcl-2 inhibitors with or without anti-CD20 antibodies in the management of CLL
  • Long-term efficacy and safety outcomes from early-phase studies evaluating ibrutinib in combination with venetoclax for patients with treatment-naïve and relapsed/refractory (R/R) CLL
  • Design, eligibility criteria and major findings from the Phase III GLOW trial evaluating ibrutinib/venetoclax versus chlorambucil/obinutuzumab as first-line therapy for older/unfit patients with CLL
  • Published outcomes from other Phase III trials, such as FLAIR and GAIA (CLL13), exploring the use of ibrutinib and venetoclax in combination
  • Available data sets evaluating acalabrutinib and zanubrutinib in combination with venetoclax with or without an anti-CD20 antibody
  • Ongoing Phase III efforts assessing novel doublet and triplet combinations for CLL

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

  • Incidence of side effects, such as hemorrhage, atrial fibrillation, thromboembolic events, infections, cytopenias, hypertension and headache, with ibrutinib, acalabrutinib and zanubrutinib in published clinical trials
  • Implications of outcomes from the Phase III ELEVATE-RR and ALPINE studies for selection of a BTK inhibitor in routine practice
  • FDA approval of the tablet formulation of acalabrutinib on the basis of results from the ELEVATE-PLUS trials; practical implications for patients receiving proton pump inhibitors or those with difficulty swallowing
  • Frequency of tumor lysis syndrome with venetoclax for CLL; monitoring, prophylaxis and management protocols
  • Recommended approaches to identifying and managing other common AEs reported with venetoclax, such as cytopenias, infections and gastrointestinal disorders
  • 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 Therapies for R/R CLL — Dr Woyach

  • Long-term follow-up from Phase III trials evaluating BTK or Bcl-2 inhibitors for patients with R/R CLL
  • Available research findings with and ongoing studies exploring the role of rechallenge with an agent or class of agents received in a prior line of therapy
  • Mechanistic similarities and differences between the noncovalent BTK inhibitor pirtobrutinib and covalent BTK inhibitors; implications for efficacy and tolerability
  • Updated results among patients with R/R CLL from the Phase I/II BRUIN study of pirtobrutinib; potential nonresearch role
  • Rationale for the evaluation of pirtobrutinib for patients with Richter’s transformation in the BRUIN trial; antitumor activity observed in this population
  • Ongoing Phase III trials evaluating pirtobrutinib for CLL, such as BRUIN CLL-313, BRUIN CLL-314, BRUIN CLL-321 and BRUIN CLL-322

MODULE 5: Promising Investigational Agents and Strategies — Dr Schuster

  • Biological rationale for the investigation of CD19-directed chimeric antigen receptor T-cell therapy for patients with CLL
  • Published findings with lisocabtagene maraleucel (liso-cel) monotherapy in the Phase I/II TRANSCEND CLL 004 trial; rates of complete response compared to historical controls
  • Early findings with liso-cel in combination with ibrutinib for heavily pretreated CLL
  • Mechanism of action of nemtabrutinib; early efficacy and safety data with nemtabrutinib for R/R CLL and ongoing Phase III evaluation for treatment-naïve disease
  • Antitumor activity observed with bispecific antibody therapy among patients with CLL, including those with Richter’s transformation
  • Other promising agents and strategies under investigation for CLL

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

  • Individualize the selection of systemic therapy for patients with newly diagnosed CLL, considering new research findings, clinical presentation, biomarker profile, coexisting medical conditions and individual preferences.
  • Appraise available Phase III data documenting the comparative efficacy and tolerability of first- and second-generation Bruton tyrosine kinase (BTK) inhibitors, and consider the implications of these findings for clinical decision-making for patients with newly diagnosed or previously treated CLL.
  • Appreciate the scientific rationale for the investigation of combined BTK and Bcl-2 inhibition, and review recently presented data documenting the safety and efficacy of this strategy for patients with newly diagnosed CLL.
  • Analyze how age, performance status, prior therapeutic exposure and other biological and disease-related factors impact the selection and sequencing of therapy for patients with relapsed/refractory (R/R) CLL.
  • Discuss available clinical research findings demonstrating the efficacy and safety of noncovalent BTK inhibitors for CLL, and use this information to evaluate the potential role of these agents in therapy for R/R disease.
  • Evaluate the biological rationale for the investigation of CD19-directed chimeric antigen receptor T-cell therapy for patients with CLL, and appropriately refer patients for ongoing studies.
  • Implement a plan of care to recognize and manage side effects and toxicities associated with recently approved and emerging systemic therapies employed in the management of CLL.
  • Recall available data with novel agents and combination strategies currently under investigation for CLL, and refer eligible patients for clinical trial participation.

CME Credit Form
A CME credit link will be given to each participant at the conclusion of the activity.

Accreditation Statement
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

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

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 conflicts of interest 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 — The following faculty reported relevant financial relationships with ineligible entities:

Dr Awan — Consulting Agreements: AbbVie Inc, Adaptive Biotechnologies Corporation, ADC Therapeutics, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, Cardinal Health, Caribou Biosciences, Celgene Corporation, Cellectar Biosciences Inc, DAVA Oncology, Epizyme Inc, Genentech, a member of the Roche Group, Genmab US Inc, Gilead Sciences Inc, Incyte Corporation, Janssen Biotech Inc, Johnson & Johnson Pharmaceuticals, Karyopharm Therapeutics, Kite, A Gilead Company, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, MEI Pharma Inc, Merck, Pharmacyclics LLC, an AbbVie Company, Verastem Inc; Contracted Research: Pharmacyclics LLC, an AbbVie Company. Dr Davids — Consulting Agreements: AbbVie Inc, Adaptive Biotechnologies Corporation, Ascentage Pharma, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, Genentech, a member of the Roche Group, Janssen Biotech Inc, Lilly, Merck, Novartis, Nuvalent; Contracted Research (Investigator on the Grant): Novartis and Ascentage Pharma (grants manager to Dr Davids: Roberto Avalos, DFCI); Nonrelevant Financial Relationship: German CLL Study Group (CLL17 safety monitoring board chair), UpToDate (authorship royalties). Dr Schuster — Advisory Committee: Caribou Biosciences Inc, Genentech, a member of the Roche Group, Nordic Nanovector, Novartis, viTToria Biotherapeutics Inc; Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Caribou Biosciences Inc, Genentech, a member of the Roche Group, Genmab US Inc, Incyte Corporation, Janssen Biotech Inc, Kite, A Gilead Company, Legend Biotech, MorphoSys, Mustang Bio, Novartis; Contracted Research: AbbVie Inc, Bristol Myers Squibb, DTRMBiopharma Co Ltd, Genentech, a member of the Roche Group, Genmab US Inc, Incyte Corporation, Juno Therapeutics, a Celgene Company, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Novartis; Data and Safety Monitoring Board/Committee: Fate Therapeutics; Inventor on Patent: “Combination therapies of chimeric antigen receptors and PD-1 inhibitors,” Owned by Penn and licensed by Novartis. Dr Wierda — Contracted Research: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Accutar Biotechnology Inc, Bristol Myers Squibb, Cyclacel Pharmaceuticals Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, GSK, Janssen Biotech Inc, Juno Therapeutics, a Celgene Company, Kite, A Gilead Company, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Novartis, Numab Therapeutics AG, Nurix Therapeutics Inc — Supported by the NIH/NCI under award number P30 CA016672 and using MDACC Cancer Center Support Grant (CCSG) shared resources, Oncternal Therapeutics, Pharmacyclics LLC, an AbbVie Company; Nonrelevant Financial Relationship: National Comprehensive Cancer Network (Chair, CLL). Dr Woyach — Advisory Committee and Consulting Agreements: AbbVie Inc, ArQule Inc, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Genentech, a member of the Roche Group, Janssen Biotech Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Newave Pharmaceutical Inc, Pharmacyclics LLC, an AbbVie Company; Contracted Research: AbbVie Inc, Karyopharm Therapeutics, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, MingSight Pharmaceuticals, MorphoSys, Schrödinger, Verastem Inc.

MODERATOR — 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: AbbVie Inc, Adaptive Biotechnologies Corporation, ADC Therapeutics, Agios Pharmaceuticals Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, BeyondSpring Pharmaceuticals Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celgene Corporation, Clovis Oncology, Coherus BioSciences, CTI Biopharma, a Sobi company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, EMD Serono Inc, Epizyme Inc, Exact Sciences Corporation, Exelixis Inc, Five Prime Therapeutics Inc, Foundation Medicine, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Genmab US Inc, Gilead Sciences Inc, Grail Inc, GSK, Halozyme Inc, Helsinn Healthcare SA, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Kronos Bio Inc, Legend Biotech, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Dainippon Pharma Oncology Inc, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, Tesaro, A GSK Company, TG Therapeutics Inc, Turning Point Therapeutics Inc, Verastem Inc, and Zymeworks Inc.

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

Supporters
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, and Lilly.

Omni San Diego Hotel
675 L Street
San Diego, CA 92101
Phone: (619) 231-6664

Meeting Room
Grand Ballroom (Level 2)

Directions
Located directly across from the San Diego Convention Center, where the 2023 ASH Annual Meeting is taking place.

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

There is no fee to participate in this hybrid event. For the in-person symposium in San Diego preregistration is required as seating is limited.

NOTICE: Registration for this event is independent of registration for the ASH Annual Meeting.

IN-PERSON Registration for clinicians in practice/healthcare professionals

I am a practicing physician, fellow, nurse or other healthcare provider involved in the treatment of cancer.

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IN-PERSON Registration for other/industry professionals*

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LIVE WEBCAST Registration for all professionals

Please note, we will stream this event over Zoom. After registering you will receive a separate confirmation from Zoom with the viewing instructions.

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