What Clinicians Want to Know: Addressing Community Oncologists’ Questions About the Current and Future Role of Antibody-Drug Conjugates in the Management of Breast Cancer

Faculty

Faculty

Professor Giuseppe Curigliano

MD, PhD

University of Milano European Institute of Oncology, Milano, Italy

Clinical Director, Division of Early Drug Development for Innovative Therapy, Co-Chair, Cancer Experimental Therapeutics Program, Department of Oncology and Hemato-Oncology

Faculty

Rebecca A Dent

MD, MSc

National Cancer Centre Singapore, Singapore

Senior Consultant

Faculty

Erika Hamilton

MD

SCRI Oncology Partners Nashville, Tennessee

Chief Development Officer, Late Phase Director, Breast Cancer Research Program Sarah Cannon Research Institute

Faculty

Nadia Harbeck

MD, PhD

LMU University Hospital Munich, Germany

Breast Center Director Department of Obstetrics and Gynecology and Comprehensive Cancer Center Munich

Moderator

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

UCSF

Professor Emeritus

Program Schedule — Central Time
6:30 PM – 7:00 PM — Registration and Dinner
7:00 PM – 9:00 PM — Educational Meeting

MODULE 1: Evolving Role of Antibody-Drug Conjugates (ADCs) in the Management of Metastatic Triple-Negative Breast Cancer (mTNBC)

• Scientific rationale for investigating TROP2-directed ADCs for previously untreated mTNBC
• Key efficacy and safety data from the Phase III ASCENT-04/KEYNOTE-D19 and ASCENT-03 trials evaluating sacituzumab govitecan in combination with pembrolizumab and as monotherapy for patients with previously untreated PD-L1-positive and PD-L1-negative mTNBC, respectively
• Recently published data from the Phase III TROPION-Breast02 study of first-line datopotamab deruxtecan (Dato-DXd) versus chemotherapy for patients with advanced TNBC for whom immunotherapy was not an option
• Potential roles of sacituzumab govitecan and Dato-DXd for previously untreated mTNBC
• Updated data with trastuzumab deruxtecan (T-DXd) in the subset of patients with previously treated hormone receptor (HR)-negative, HER2-low advanced breast cancer in the Phase III DESTINY-Breast04 study; current role alongside other treatment options
• Clinical trial findings with and ongoing investigation of other ADCs for mTNBC, such as sacituzumab tirumotecan and izalontamab brengitecan

MODULE 2: Integrating ADCs into the Management of HER2-Positive Metastatic Breast Cancer (mBC)

• Historical outcomes with standard HER2-targeted therapies for newly diagnosed HER2-positive mBC; rationale for the evaluation of HER2-targeted ADCs in the front-line setting
• Published efficacy and safety findings from the Phase III DESTINY-Breast09 trial documenting the benefit of T-DXd/pertuzumab versus taxane/trastuzumab/pertuzumab as first-line therapy for HER2-positive mBC
• Implications of the DESTINY-Breast09 trial for sequencing therapies for HER2-positive mBC
• Intracranial efficacy documented with T-DXd in published clinical trials, including DESTINY-Breast01, 02 and 03, DESTINY-Breast12, DEBBRAH and TUXEDO-1; implications for the management of HER2-positive mBC
• Outcomes documented among patients with previously treated HER2-positive mBC without CNS involvement in pivotal clinical studies of T-DXd
• Other promising HER2-directed ADCs under investigation for HER2-positive mBC

MODULE 3: Role of ADCs in the Management of Endocrine-Resistant HR-Positive mBC

• Long-term efficacy and safety findings from the Phase III TROPiCS-02 trial of sacituzumab govitecan for previously treated HR-positive, HER2-negative mBC
• Optimal integration of sacituzumab govitecan into management algorithms for HR-positive, HER2-negative disease
• Available efficacy and safety findings from the Phase III TROPION-Breast01 study of Dato-DXd versus investigator’s choice of chemotherapy for pretreated HR-positive, HER2-negative mBC
• FDA approval of Dato-DXd for patients with HR-positive, HER2-negative mBC who have previously received endocrine-based therapy and chemotherapy; current clinical role
• Available data from the DESTINY-Breast04 and DESTINY-Breast06 studies evaluating T-DXd versus chemotherapy for patients with previously treated HER2-low and HER2-ultralow advanced breast cancer
• FDA approval of T-DXd for advanced HR-positive, HER2-low and HER2-ultralow breast cancer progressing after one or more endocrine therapies in the metastatic setting; optimal incorporation into disease management

MODULE 4: Emerging Utility of ADCs for Localized Breast Cancer

• Key clinical factors in the selection of neoadjuvant and adjuvant systemic therapy for patients with HER2-positive localized breast cancer; effect of various therapeutic approaches on outcomes
• Published findings from the Phase III DESTINY-Breast11 study evaluating T-DXd as a component of neoadjuvant therapy for patients with high-risk, HER2-positive localized breast cancer
• Recently presented data from the Phase III DESTINY-Breast05 study of T-DXd versus T-DM1 for patients with high-risk HER2-positive breast cancer and residual invasive disease after neoadjuvant therapy
• Implications of the DESTINY-Breast11 and DESTINY-Breast05 studies for the management of HER2-positive localized breast cancer
• Ongoing Phase III trials, such as ASCENT-05, ADAPT-TN-III, ADAPT-TN-IV, TROPION-Breast04, TROPION-Breast05, TroFuse-012 and TroFuse-032, evaluating TROP2 ADCs as a component of neoadjuvant or adjuvant therapy for localized disease; estimated completion dates

MODULE 5: Tolerability Considerations with ADCs for Breast Cancer

• Spectrum, incidence and severity of common and unique adverse events (AEs) with different ADCs employed in the management of breast cancer
• Monitoring and management of acute “chemotherapy-like” AEs reported with ADCs, such as cytopenias and gastrointestinal events
• Recommended algorithms for mitigating more serious (eg, interstitial lung disease, left ventricular dysfunction) or unique (eg, oral mucositis/stomatitis, ocular AEs) toxicities documented with one or more ADCs
• Strategies to distinguish the cause of AEs that could be attributable to either agent in ADC-containing combination regimens
• Impact on tolerability, if any, of the placement of ADCs in the treatment course (eg, later-line therapy for metastatic disease, first-line therapy for metastatic disease or neoadjuvant/adjuvant therapy)

Target Audience
This activity is intended for medical and radiation oncologists, hematologists, hematology-oncology fellows, general and breast surgeons and other healthcare providers involved in the treatment of breast cancer.

Learning Objectives
To be announced.

CME Credit Form
A CME credit link will be given to each participant as part of the meeting course materials.

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

Prof Curigliano — Advisory Committees, Consulting Agreements and Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc; Data and Safety Monitoring Boards/Committees: Roche Laboratories Inc. Dr Hamilton — Consulting/Advisory Roles (All Payments to Institution): Accutar Biotechnology Inc, Arvinas, AstraZeneca Pharmaceuticals LP, BeOne, Circle Pharma, Daiichi Sankyo Inc, Entos Pharmaceuticals, Genentech, a member of the Roche Group, Gilead Sciences Inc, Halda Therapeutics, Incyclix Bio, IQVIA, Janssen Biotech Inc, Jazz Pharmaceuticals Inc, Jefferies LLC, Johnson & Johnson, Lilly, Medical Pharma Services SRO, Mersana Therapeutics Inc, Novartis, Pfizer Inc, Pyxis Oncology, Samsung Bioepis, Shorla Oncology, Stemline Therapeutics Inc, Tempus, Zentalis Pharmaceuticals; Research Funding (All Payments to Institution): AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Accutar Biotechnology Inc, ADC Therapeutics, Akesobio Australia Pty Ltd, Amgen Inc, Aravive Inc, ARS Pharmaceuticals, Artios Pharma Limited, Arvinas, AstraZeneca Pharmaceuticals LP, AtlasMedx Inc, BeOne, Black Diamond Therapeutics Inc, Bliss Biopharmaceutical (Hangzhou) Co Ltd, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Compugen, Context Therapeutics, Cullinan Therapeutics, Curis Inc, CytomX Therapeutics, Daiichi Sankyo Inc, Dantari, Deciphera Pharmaceuticals Inc, Duality Biologics, eFFECTOR Therapeutics Inc, Eisai Inc, Ellipses Pharma, Elucida Oncology Inc, EMD Serono Inc, Fochon Pharmaceuticals, FUJIFILM Pharmaceuticals USA Inc, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Harpoon Therapeutics, Hutchison MediPharma, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Inspirna, InventisBio, Jacobio Pharmaceuticals Group Co Ltd, Karyopharm Therapeutics, K-Group Beta, Kind Pharmaceuticals LLC, Leap Therapeutics Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Lycera, MacroGenics Inc, Marker Therapeutics Inc, Merck, Mereo BioPharma, Mersana Therapeutics Inc, Merus, Molecular Templates, Myriad Genetic Laboratories Inc, Novartis, NuCana, Olema Oncology, Oncothyreon, ORIC Pharmaceuticals, Orinove Inc, Orum Therapeutics, Pfizer Inc, pharmaand GmbH, PharmaMar, Pieris Pharmaceuticals Inc, Pionyr Immunotherapeutics, Plexxikon Inc, Prelude Therapeutics, ProFound Therapeutics, Radius Health Inc, Regeneron Pharmaceuticals Inc, Relay Therapeutics, Repertoire Immune Medicines, Seagen Inc, Sermonix Pharmaceuticals, Shattuck Labs, Stemline Therapeutics Inc, Sutro Biopharma, Syndax Pharmaceuticals, Syros Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, Tesaro, A GSK Company, Tolmar, Transcenta, Treadwell Therapeutics, Verastem Inc, Zenith Epigenetics, Zymeworks Inc; Nonrelevant Financial Relationships: Dana-Farber Cancer Institute. Prof Harbeck — Consulting Agreements: Exact Sciences Corporation, Sandoz Inc, a Novartis Division; Data and Safety Monitoring Boards/Committees: Gilead Sciences Inc, IQVIA, Roche Laboratories Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Gilead Sciences Inc, Lilly, Menarini Group, MSD, Novartis, Pfizer Inc, Pierre Fabre, Roche Laboratories Inc, Stemline Therapeutics Inc, Viatris, Zuellig Pharma; Nonrelevant Financial Relationships: West German Study Group (WSG). Additional faculty to be announced.

MODERATOR
Dr Rugo — Advisory Committees and Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research (Funding to City of Hope): Bicycle Therapeutics, Genentech, a member of the Roche Group, Merck, Stemline Therapeutics Inc; Contracted Research (Funding to Prior Institution, UCSF): Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics 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 Daiichi Sankyo Inc.

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