STEERING COMMITTEE

Inhye Ahn

MD

Dana-Farber Cancer Institute Boston, Massachusetts

Assistant Professor of Medicine

Farrukh T Awan

MD

University of Texas Southwestern Medical Center, Dallas, Texas

Professor of Internal Medicine, Associate Director, Section of Hematologic Malignancies/Transplantation and Cellular Therapies, Director of Lymphoid Malignancies Program, Harold C Simmons Comprehensive Cancer Center

Catherine C Coombs

MD

UCI Health, Orange County, California

Associate Clinical Professor, Division of Hematology/Oncology, Department of Medicine

Matthew S Davids

MD, MMSc

Harvard Medical School, Boston, Massachusetts

Associate Professor of Medicine

Dana-Farber/Harvard Cancer Center, Boston, Massachusetts

Leader, Lymphoma Program

Dana-Farber Cancer Institute, Boston, Massachusetts

Director of Clinical Research, Division of Lymphoma

Bita Fakhri

MD, MPH

Stanford University School of Medicine, Stanford, California

Associate Professor of Medicine (Hematology)

Nicole Lamanna

MD

NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York

Judy Horrigan Professor of Medicine, Director of the Chronic Lymphocytic Leukemia Program, Leukemia Service, Hematologic Malignancies Section, Herbert Irving Comprehensive Cancer Center

Jeff Sharman

MD

Sarah Cannon Research Institute at Willamette Valley Cancer Center Eugene, Oregon

Medical Director of Hematology Research

Meghan C Thompson

MD

Memorial Sloan Kettering Cancer Center New York, New York

Oncologist and Clinical Investigator Chronic Lymphocytic Leukemia Assistant Attending, Leukemia Service

William G Wierda

MD, PhD

The University of Texas MD Anderson Cancer Center, Houston, Texas

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

Jennifer Woyach

MD

The Ohio State University Comprehensive Cancer Center, Columbus, Ohio

Professor, Division of Hematology, Department of Internal Medicine

Each 1-hour session will include 4 topic modules focused on optimizing treatment for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Each event will employ an identical format that will include the following elements:

• Discussion of Steering Committee Members’ Treatment Recommendations
• Review of Available Clinical Research Findings
• Integration of Interactive Audience Q&A Discussion

MODULE 1 | Sequencing of Treatment for CLL

• Impact of the evolving up-front treatment paradigm on the management of relapsed/refractory (R/R) CLL
• Clinical and biological factors guiding decision-making for individual patients with R/R CLL
• Current role of rechallenging with an agent or class of agents administered in a prior line of therapy
• FDA approval of acalabrutinib with venetoclax for previously untreated CLL, based on results of the Phase III AMPLIFY trial

MODULE 2 | The Noncovalent Bruton Tyrosine Kinase (BTK) Inhibitor Pirtobrutinib

• Mechanistic similarities and differences between noncovalent and covalent BTK inhibitors; implications for efficacy and tolerability
• Extended follow-up from the Phase I/II BRUIN study of pirtobrutinib for patients with R/R CLL
• FDA approval and current role of pirtobrutinib in the treatment of R/R CLL
• Published efficacy and safety findings from the Phase III BRUIN CLL-321 trial evaluating pirtobrutinib versus investigator’s choice of idelalisib/rituximab or bendamustine/rituximab for BTK inhibitor-pretreated CLL
• Tolerability profile of pirtobrutinib as compared to a covalent BTK inhibitor; optimal approaches for managing common toxicities
• Study design and eligibility criteria for the ongoing BRUIN CLL-322 trial evaluating pirtobrutinib, venetoclax and rituximab versus venetoclax and rituximab for previously treated CLL/small lymphocytic lymphoma
• Recently published data from the Phase III BRUIN CLL-314 trial comparing pirtobrutinib to ibrutinib for patients with CLL, including for those with treatment-naïve disease
• Recently published data from the Phase III BRUIN CLL-313 trial comparing pirtobrutinib to bendamustine/rituximab for previously untreated CLL
• Potential clinical role of pirtobrutinib for newly diagnosed CLL

MODULE 3 | Chimeric Antigen Receptor T-Cell Therapy for 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 accelerated approval of liso-cel for CLL previously treated with a BTK inhibitor and a Bcl-2 inhibitor; current clinical role and optimal patient selection

MODULE 4 | Bispecific Antibodies and Other Promising Investigational Strategies

• Rationale for the investigation of bispecific antibodies for R/R CLL; antitumor activity and safety documented with epcoritamab in the Phase Ib/II EPCORE CLL-1 study
• Mechanistic similarities and differences between BTK degraders and BTK inhibitors
• Preliminary safety and efficacy of the BTK degrader BGB-16673 for patients with heavily pretreated CLL in the Phase I CaDAnCe-101 study
• Other promising agents and strategies under investigation for CLL

Each session will conclude with a 5-minute Q&A segment.

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

• Analyze how age, performance status, prior therapeutic exposure and other biological and disease-related factors affect the selection of therapy for patients who experience relapse after first-line treatment for CLL.
• Appraise the similarities and differences between covalent and noncovalent Bruton tyrosine kinase (BTK) inhibitors, and recognize the implications for clinical activity and tolerability.
• Discuss available clinical research demonstrating the efficacy and safety of noncovalent BTK inhibitors for relapsed/refractory CLL, and use this information to effectively incorporate these agents into the treatment of disease that has previously been treated with a covalent BTK inhibitor.
• Appreciate recent clinical research with noncovalent BTK inhibitors for patients with treatment-naïve or BTK inhibitor-naïve CLL, and discern the implications of these findings for therapeutic selection and sequencing.
• Evaluate the biological rationale for the investigation of CD19-directed chimeric antigen receptor T-cell therapy for CLL, and identify patients for whom this novel therapeutic strategy would be appropriate.
• Appraise clinical investigator best practices for various relapsed/refractory CLL management situations, and leverage this information to improve shared decision-making with patients.
• Recall available and emerging data with novel agents and combination strategies currently under investigation in CLL, and appropriately refer patients for clinical trial participation.

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

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

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

American Board of Internal Medicine (ABIM) — Maintenance of Certification (MOC)
Successful completion of each CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1 Medical Knowledge MOC point in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. 

Please note, this program has been specifically designed for the following ABIM specialties: medical oncology and hematology. 

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Unlabeled/Unapproved Uses Notice
These educational activities 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 grantor.

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 each 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 will be provided.

Steering Committee
Dr Ahn — Consulting Agreements: AstraZeneca Pharmaceuticals LP, BeOne, Lilly; Contracted Research: BeOne, Genentech, a member of the Roche Group, Lilly. Dr Awan — Consulting Agreements: AbbVie Inc, Adaptive Biotechnologies Corporation, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, DAVA Oncology, Genmab US Inc, Incyte Corporation, Invivyd, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Miltenyi Biotec, Pierre Fabre; Contracted Research: Actinium Pharmaceuticals Inc, Pharmacyclics LLC, an AbbVie Company; Data and Safety Monitoring Boards/Committees: Ascentage Pharma, AstraZeneca Pharmaceuticals LP, Caribou Biosciences Inc. Dr Coombs — Advisory Committees: AbbVie Inc, Allogene Therapeutics, AstraZeneca Pharmaceuticals LP, BeOne, Genentech, a member of the Roche Group, Johnson & Johnson, Lilly, Pharmacyclics LLC, an AbbVie Company; Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Lilly, Octapharma; Contracted Research: AbbVie Inc, BeOne, Carna Biosciences, Lilly; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, BeOne, Lilly; Stock Options/Stock — Public Companies: Geron Corporation. Dr Davids — Consulting Agreements: AbbVie Inc, Adaptive Biotechnologies Corporation, Ascentage Pharma, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Galapagos NV, Genentech, a member of the Roche Group, Genmab US Inc, Janssen Biotech Inc, Lilly, MEI Pharma Inc, Merck, Nuvalent, Schrödinger, Takeda Pharmaceuticals USA Inc; Contracted Research: Ascentage Pharma, AstraZeneca Pharmaceuticals LP, MEI Pharma Inc, Novartis; Nonrelevant Financial Relationships: UpToDate. 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 Lamanna — Advisory Committees and Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Genmab US Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company; Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Genmab US Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Octapharma, Oncternal Therapeutics. Dr Sharman — Advisory Committees: AbbVie Inc, Genentech, a member of the Roche Group, Novartis; Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Genentech, a member of the Roche Group, Lilly. Dr Thompson — Advisory Boards and Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Genentech, a member of the Roche Group, Genmab US Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Nurix Therapeutics Inc; Research Funding (Paid to Institution): AbbVie Inc, Adaptive Biotechnologies Corporation, AstraZeneca Pharmaceuticals LP, BeOne, Genentech, a member of the Roche Group, Genmab US Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Nurix Therapeutics Inc; Travel Support: DAVA Oncology. 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). Dr Woyach — Advisory Committees and Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Genentech, a member of the Roche Group, Janssen Biotech Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Newave, 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.

Program Chair
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 conflicts of interest to disclose.

Supporter
These activities are supported by an educational grant from Lilly.