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Expert Answers to Common Questions for Tailoring ADC Therapies Across the HER2 Spectrum in Metastatic Breast Cancer

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Expert Answers to Common Questions for Tailoring ADC Therapies Across the HER2 Spectrum in Metastatic Breast Cancer

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  • Overview

    HER2 is a well-established negative prognostic factor for metastatic breast cancer (mBC) and determining HER2 levels is essential for proper treatment decisions. Several studies have reported scoring inaccuracies for HER2 status, particularly in the low range (0 and 1+), and challenges with IHC assessment and interpretation can lead to the misassignment of many patients for treatment. Antibody-drug conjugates (ADCs), a new and promising class of therapeutics designed as targeted therapy for mBC, target and kill tumor cells while sparing healthy cells. Rapid advances in ADC development are transforming HER2-positive and HER2-low mBC patient outcomes. With recent FDA approvals of HER2-targeting agents and emerging positive trial data, clinicians and pathologists are faced with staying abreast of and integrating new treatment options into real-world clinical practice. 

    AXIS routinely collects and analyzes data gathered from participants in our live activities. These questions and answers provide incredible insight regarding testing methodologies to classify metastatic breast cancer according to HER2 status, addressing the strengths and limitations of different techniques. The clinical implications of these tests for guiding HER2-targeted therapies such as antibody-drug conjugates will be addressed, as well as evidence-based methods to address challenges such as treatment-associated adverse events and drug resistance, and key messages pertaining to the management of patients with metastatic breast cancer.   

  • Disclosure of Conflicts of Interest

    Disclosure of Relevant Financial Relationships 
    AXIS Medical Education requires faculty, instructors, authors, planners, directors, managers, peer reviewers, and other individuals who are in a position to control the content of this activity to disclose all personal financial relationships they may have in the past 24 months with ineligible companies. An ineligible entity is any organization whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. All relevant financial relationships are identified and mitigated prior to initiation of the planning phase for an activity.  

     AXIS has mitigated and disclosed to learners all relevant financial relationships disclosed by staff, planners, faculty/authors, peer reviewers, or others in control of content for this activity. Disclosure of a relationship is not intended to suggest or condone bias in any presentation but is made to provide participants with information that might be of potential importance to their evaluation of a presentation or activity. Disclosure information for faculty, authors, course directors, planners, peer reviewers, and/or relevant staff is provided with this activity. 

    The author, Sara M. Tolaney, MD, MPH, reported the following relevant financial relationships or relationships she has with ineligible companies of any amount during the past 24 months. PI of study/Consultant/Advisory boards/Research support to institution; AstraZeneca Pharmaceuticals LP, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer, Genentech/Roche, Gilead, Bristol-Myers Squibb Company, Eisai Inc. PI of study/Research support to institution; OncoPep, Exelixis, Inc., Nanostring, Cyclacel. PI of study/Advisory Board; Sanofi. PI of study/Consultant/Advisory Board; Seattle Genetics, Inc. PI of study/Consultant; Daiichi-Sankyo, Inc. PI of study/Steering committee/Consultant; CytomX. PI of study/Consultant/Advisory boards/Steering committee; Eli Lilly. Advisory board; 4D Pharm,BeyondSpring Pharmaceuticals, Zymeworks, Zentalis, Reveal Genomics, ARC Therapeutics, Myovant, Umoja Biopharma, Artios Biopharmaceuticals, Incyte Corporation, Bayer. Advisory board/Consultant; Menarini/Stemline. Steering committee; OncXerna. Consultant; Blueprint Medicines, Aadi Bio, Zetagen. 

    The  directors, planners, managers, peer reviewers, and relevant staff  reported the following financial relationships they have with any ineligible company of any amount during the past 24 months: Linda Gracie-King, MS; Elizabeth Lurwick, BS; Marilyn L. Haas-Haseman,  PhD, RN, CNS, ANP-BC; Adrienne N. Nedved, MPA, PharmD, BCOP; Melissa Duffy, PA-C; and Dee Morgillo, MEd, MT(ASCP), CHCP, hereby state that they do not have any financial relationships or relationships any ineligible company of any amount during the past 24 months. Robert Mocharnuk, MD, reported a financial interest/relationship or affiliation in the form of Common stock; Merck of any amount during the past 24 months. 

     

  • Learning Objectives

    After participating in this educational activity, participants should be better able to:

    1. Apply new strategies based on available detection methods and guideline recommendations to account for disease heterogeneity and properly assess HER2 status.
    2. Incorporate the accumulating body of evidence from current clinical trials and real-world data on ADCs and their implications in HER2-positive and HER2-low breast cancer into personalized patient treatment planning.
    3. Employ strategies to identify, mitigate, and manage potential treatment-related adverse events in patients receiving HER2-directed ADC therapies 
  • Target Audience

    This educational activity is designed for US-based medical oncologists, pathologists/lab professionals, oncology nurse practitioners, physician assistants, oncology nurses, nurse navigators, and pharmacists who are part of the interprofessional team responsible for the management of patients with HER2-positive and HER2-low metastatic breast cancer. 

  • Accreditation and Credit Designation Statements

    Accreditation Statement 
    In support of improving patient care, AXIS Medical Education is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. 

    This activity was planned by and for the healthcare team, and learners will receive 0.25 Interprofessional Continuing Education (IPCE) credit for learning and change.

    Credit Designation for Physicians 
    AXIS Medical Education designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 

    Credit Designation for Physician Assistants 

    AXIS Medical Education has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.25 AAPA Category 1 CME credits.  Approval is valid until 2/5/2025 PAs should only claim credit commensurate with the extent of their participation. 

    Credit Designation for Pharmacists 
    This knowledge-based activity is approved for 0.25 contact hour of continuing pharmacy education JA4008106-0000-24-003-H01-P. 

    Credit Designation for Nursing 
    AXIS Medical Education designates this continuing nursing education activity for 0.25 contact hours. 

    Learners are advised that accredited status does not imply endorsement by the provider or ANCC of any commercial products displayed in conjunction with an activity. 

    Laboratory Professionals 
    This continuing medical laboratory education activity is recognized by the American Society for Clinical Pathology as meeting the criteria for 0.25 CMLE credit. ASCP CMLE credits are acceptable to meet the continuing education requirement for the ASCP Board of Registry Certification Maintenance Program.

  • Provider(s)/Educational Partner(s)

    Provided by

  • Commercial Support

    This activity is supported by educational grants from AstraZeneca Pharmaceuticals and Daiichi Sankyo. 

  • Disclaimer

    Disclosure of Unlabeled Use  
    This educational activity may contain discussion of agents that are not approved for use by the FDA and/or investigational (“off-label”) uses of agents that are approved by the FDA. The planners of this activity do not recommend the use of any agent outside of its labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each agent for information on its approved indications, contraindications, warnings, and other, related information. 

    Disclaimer 
    Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. 

  • System Requirements

    Our site requires a computer, tablet, or mobile device and a connection to the Internet. For best results, a high-speed Internet connection is recommended (DSL/Cable/Fibre). We also recommend using the latest version of your favorite browser to ensure compliance with W3C standards, such as Chrome, Safari, Firefox, or Microsoft Edge.

  • Publication Dates

    Release Date:

    Expiration Date:

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Details
Presenters
Related
Comments
  • Overview

    HER2 is a well-established negative prognostic factor for metastatic breast cancer (mBC) and determining HER2 levels is essential for proper treatment decisions. Several studies have reported scoring inaccuracies for HER2 status, particularly in the low range (0 and 1+), and challenges with IHC assessment and interpretation can lead to the misassignment of many patients for treatment. Antibody-drug conjugates (ADCs), a new and promising class of therapeutics designed as targeted therapy for mBC, target and kill tumor cells while sparing healthy cells. Rapid advances in ADC development are transforming HER2-positive and HER2-low mBC patient outcomes. With recent FDA approvals of HER2-targeting agents and emerging positive trial data, clinicians and pathologists are faced with staying abreast of and integrating new treatment options into real-world clinical practice. 

    AXIS routinely collects and analyzes data gathered from participants in our live activities. These questions and answers provide incredible insight regarding testing methodologies to classify metastatic breast cancer according to HER2 status, addressing the strengths and limitations of different techniques. The clinical implications of these tests for guiding HER2-targeted therapies such as antibody-drug conjugates will be addressed, as well as evidence-based methods to address challenges such as treatment-associated adverse events and drug resistance, and key messages pertaining to the management of patients with metastatic breast cancer.   

  • Disclosure of Conflicts of Interest

    Disclosure of Relevant Financial Relationships 
    AXIS Medical Education requires faculty, instructors, authors, planners, directors, managers, peer reviewers, and other individuals who are in a position to control the content of this activity to disclose all personal financial relationships they may have in the past 24 months with ineligible companies. An ineligible entity is any organization whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. All relevant financial relationships are identified and mitigated prior to initiation of the planning phase for an activity.  

     AXIS has mitigated and disclosed to learners all relevant financial relationships disclosed by staff, planners, faculty/authors, peer reviewers, or others in control of content for this activity. Disclosure of a relationship is not intended to suggest or condone bias in any presentation but is made to provide participants with information that might be of potential importance to their evaluation of a presentation or activity. Disclosure information for faculty, authors, course directors, planners, peer reviewers, and/or relevant staff is provided with this activity. 

    The author, Sara M. Tolaney, MD, MPH, reported the following relevant financial relationships or relationships she has with ineligible companies of any amount during the past 24 months. PI of study/Consultant/Advisory boards/Research support to institution; AstraZeneca Pharmaceuticals LP, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer, Genentech/Roche, Gilead, Bristol-Myers Squibb Company, Eisai Inc. PI of study/Research support to institution; OncoPep, Exelixis, Inc., Nanostring, Cyclacel. PI of study/Advisory Board; Sanofi. PI of study/Consultant/Advisory Board; Seattle Genetics, Inc. PI of study/Consultant; Daiichi-Sankyo, Inc. PI of study/Steering committee/Consultant; CytomX. PI of study/Consultant/Advisory boards/Steering committee; Eli Lilly. Advisory board; 4D Pharm,BeyondSpring Pharmaceuticals, Zymeworks, Zentalis, Reveal Genomics, ARC Therapeutics, Myovant, Umoja Biopharma, Artios Biopharmaceuticals, Incyte Corporation, Bayer. Advisory board/Consultant; Menarini/Stemline. Steering committee; OncXerna. Consultant; Blueprint Medicines, Aadi Bio, Zetagen. 

    The  directors, planners, managers, peer reviewers, and relevant staff  reported the following financial relationships they have with any ineligible company of any amount during the past 24 months: Linda Gracie-King, MS; Elizabeth Lurwick, BS; Marilyn L. Haas-Haseman,  PhD, RN, CNS, ANP-BC; Adrienne N. Nedved, MPA, PharmD, BCOP; Melissa Duffy, PA-C; and Dee Morgillo, MEd, MT(ASCP), CHCP, hereby state that they do not have any financial relationships or relationships any ineligible company of any amount during the past 24 months. Robert Mocharnuk, MD, reported a financial interest/relationship or affiliation in the form of Common stock; Merck of any amount during the past 24 months. 

     

  • Learning Objectives

    After participating in this educational activity, participants should be better able to:

    1. Apply new strategies based on available detection methods and guideline recommendations to account for disease heterogeneity and properly assess HER2 status.
    2. Incorporate the accumulating body of evidence from current clinical trials and real-world data on ADCs and their implications in HER2-positive and HER2-low breast cancer into personalized patient treatment planning.
    3. Employ strategies to identify, mitigate, and manage potential treatment-related adverse events in patients receiving HER2-directed ADC therapies 
  • Target Audience

    This educational activity is designed for US-based medical oncologists, pathologists/lab professionals, oncology nurse practitioners, physician assistants, oncology nurses, nurse navigators, and pharmacists who are part of the interprofessional team responsible for the management of patients with HER2-positive and HER2-low metastatic breast cancer. 

  • Accreditation and Credit Designation Statements

    Accreditation Statement 
    In support of improving patient care, AXIS Medical Education is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. 

    This activity was planned by and for the healthcare team, and learners will receive 0.25 Interprofessional Continuing Education (IPCE) credit for learning and change.

    Credit Designation for Physicians 
    AXIS Medical Education designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 

    Credit Designation for Physician Assistants 

    AXIS Medical Education has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.25 AAPA Category 1 CME credits.  Approval is valid until 2/5/2025 PAs should only claim credit commensurate with the extent of their participation. 

    Credit Designation for Pharmacists 
    This knowledge-based activity is approved for 0.25 contact hour of continuing pharmacy education JA4008106-0000-24-003-H01-P. 

    Credit Designation for Nursing 
    AXIS Medical Education designates this continuing nursing education activity for 0.25 contact hours. 

    Learners are advised that accredited status does not imply endorsement by the provider or ANCC of any commercial products displayed in conjunction with an activity. 

    Laboratory Professionals 
    This continuing medical laboratory education activity is recognized by the American Society for Clinical Pathology as meeting the criteria for 0.25 CMLE credit. ASCP CMLE credits are acceptable to meet the continuing education requirement for the ASCP Board of Registry Certification Maintenance Program.

  • Provider(s)/Educational Partner(s)

    Provided by

  • Commercial Support

    This activity is supported by educational grants from AstraZeneca Pharmaceuticals and Daiichi Sankyo. 

  • Disclaimer

    Disclosure of Unlabeled Use  
    This educational activity may contain discussion of agents that are not approved for use by the FDA and/or investigational (“off-label”) uses of agents that are approved by the FDA. The planners of this activity do not recommend the use of any agent outside of its labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each agent for information on its approved indications, contraindications, warnings, and other, related information. 

    Disclaimer 
    Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. 

  • System Requirements

    Our site requires a computer, tablet, or mobile device and a connection to the Internet. For best results, a high-speed Internet connection is recommended (DSL/Cable/Fibre). We also recommend using the latest version of your favorite browser to ensure compliance with W3C standards, such as Chrome, Safari, Firefox, or Microsoft Edge.

  • Publication Dates

    Release Date:

    Expiration Date:

Facebook Comments

Schedule2 Mar 2024