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Faculty & Disclosures

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    Faculty & Disclosures
    Prof. Peter Galle

    University Medical Center Mainz, Germany

    Peter Galle is professor of medicine and director of the First Department of Internal Medicine at University Medical Center, Mainz, Germany. read more

    His research has focused on elucidating important aspects of apoptotic cell death in the liver, immune escape of tumour cells, and the clinical and molecular aspects of hepatocellular carcinoma (HCC). He chaired the panel updating the European Association for the Study of the Liver (EASL) Clinical Practice Guideline on HCC which appeared in 2018. 

    Prof. Galle is a member of several national and international societies, such as the American Association for the Study of Liver Diseases (AASLD) and the EASL. He served as co-editor for the Journal of Hepatology and was on the editorial boards of several other journals. He served as congress president of the German Society for Digestive Diseases (DGVS) in 2014. He was a member of the executive board and president of the international Liver Cancer Association (ILCA). He was president-elect of the German Association for the Study of the Liver (GASL) for the year 2020.

    Prof. Galle has been awarded several prizes, amongst others the prestigious Tannhauser award, the highest prize of the German Society for Digestive Diseases. He has published more than 500 peer-reviewed papers.

    Prof. Peter Galle discloses: Advisory board, panel and consultancy fees from AstraZeneca, Bayer, BMS, Eisai, Guerbet Pharma, Ipsen, Lilly, MSD and Roche.
    Dr Victor Moreno

    START Madrid-FJD, Hospital Fundación Jiménez Díaz, Madrid, Spain

    Victor Moreno is the director of clinical research at START-Madrid-Fundación Jimenez Diaz (FJD). read more

    Dr Moreno is a clinical researcher dedicated exclusively to early clinical trials and drug development with special focus on targeted therapies, cancer immunotherapy and adoptive cell therapy. His team has been actively involved in the development of modified T-cell receptors for solid tumours, including MAGE-A10, MAGE-A4 and NY-ESO, as well as tumour-infiltrating lymphocytes for different solid tumours. He has published more than 40 articles in journals such as The New England Journal of Medicine, Nature, Journal of Clinical Oncology and Lancet Oncology.

    Dr Victor Moreno discloses:  Advisory board or panel fees from Basilea, Bayer, BMS, Janssen and Roche. Research/grants from AbbVie, AceaBio, Adaptimmune, ADC Therapeutics, Aduro, Agenus, Amcure, Amgen, Astellas, AstraZeneca, Bayer Beigene BioInvent International AB, Boehringer, Boston, BMS, Celgene, Daichii Sankyo, Debiopharm, e-Terapeutics, Eisai, Exelisis, Forma Therapeutics, Genmab, GSK, Harpoon, Hutchison, Immutep, Incyte, Inovio, Iovance, Janssen, Kyowa Kirin, Lilly, Loxo, MedSir, Menarini, Merck, Merus, Millennium, MSD, Nanobiotix, Nektar, Novartis, Odonate Therapeutics, Pfizer, Pharma Mar, Principia, PsiOxus, Puma, Regeneron, Rigontec, Roche, Sanofi, Sierra Oncology, Synthon, Taiho, Takeda, Tesaro, Transgene, Turning Point Therapeutics and Upshersmith.
    Dr Vibeke Strand

    Stanford University School of Medicine, Palo Alto, CA, USA

    Vibeke Strand is an adjunct clinical professor in the Division of Immunology and Rheumatology at Stanford University School of Medicine. read more

    Since 1991, she has led a consulting practice offering clinical research and regulatory strategy expertise to pharmaceutical and biotech companies for development of new therapies in rheumatic diseases. She has participated in the development of all the approved biologic agents and targeted synthetic disease-modifying anti-rheumatic drugs in rheumatoid arthritis, as well as new therapies for psoriatic arthritis, peripheral spondyloarthritis, systemic lupus erythematosus, vasculitis, gout, biosimilars and symptomatic therapies in osteoarthritis.

    Dr Strand was previously a clinical investigator in subspecialty practice in San Francisco for 6 years, and senior director of clinical research at three pharmaceutical/biotech companies for 6 years.

    She has authored more than 490 publications, and is a fellow of the American College of Physicians, master of the American College of Rheumatology and a member of the Cosmos Club. She has been a member of the executive committee of the international Outcomes in Rheumatology Clinical Trials (OMERACT) consensus conferences since its inception in 1992, of the steering committee of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), and of the board of International Dermatology Outcome Measures (IDEOM).

    Dr Vibeke Strand discloses: Consultancy fees from AbbVie, Alpine, Alumis, Amgen Corporation, Aria, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Celltrion, ChemoCentryx, Endo, Equillium, Ermium, Genentech/Roche, Gilead, Glenmark, GSK, Horizon, Inmedix, Janssen, Kiniksa, Kypha, Lilly, Merck, MiMedx, Novartis, Pfizer, Priovant, R-Pharm, Regeneron, Rheos, Samsung, Sandoz, Sanofi, Scipher, Setpoint, SOFUSA, Spherix and Tonix.
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    Immunotherapy CE/CME accredited

    touchPANEL DISCUSSION
    A visually engaging discussion designed to emulate a ‘live’ panel experience and provide clinicians with practical expert insights to address their clinical challenges. Useful tips below will show how to navigate the activity. Close

    Immunogenicity of immune checkpoint inhibitors: What are the implications for clinical practice?

    Useful tips
    • Downloads including slides are available for this activity in the Toolkit
    Learning Objectives

    After watching this activity, participants should be better able to:

    • Describe the experience of immunogenicity from the use of biologic therapies in chronic inflammatory diseases, and how this might inform the use of immune checkpoint inhibitors in oncology
    • Review the current data for the immunogenicity of immune checkpoint inhibitors and how anti-drug antibodies impact drug efficacy and safety
    • Discuss the potential clinical implications of anti-drug antibodies (ADA) in oncology and possible strategies for management
    Overview

    In this activity, three experts discuss recent data on the immunogenicity of immune checkpoint inhibitors and their clinical relevance for the treatment of patients with cancer, based on lessons learned from biologic therapies in rheumatology and inflammatory diseases.

    This activity is jointly provided by USF Health and touchIME. read more

    Target Audience

    This activity has been designed to meet the educational needs of oncologists involved in the management of patients receiving treatment with immune checkpoint inhibitors.

    Disclosures

    USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity.  The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.

    Faculty

    Prof. Peter Galle discloses: Advisory board, panel and consultancy fees from AstraZeneca, Bayer, BMS, Eisai, Guerbet Pharma, Ipsen, Lilly, MSD and Roche.

    Dr Victor Moreno discloses: Advisory board or panel fees from Basilea, Bayer, BMS, Janssen and Roche. Research/grants from AbbVie, AceaBio, Adaptimmune, ADC Therapeutics, Aduro, Agenus, Amcure, Amgen, Astellas, AstraZeneca, Bayer Beigene BioInvent International AB, Boehringer, Boston, BMS, Celgene, Daichii Sankyo, Debiopharm, e-Terapeutics, Eisai, Exelisis, Forma Therapeutics, Genmab, GSK, Harpoon, Hutchison, Immutep, Incyte, Inovio, Iovance, Janssen, Kyowa Kirin, Lilly, Loxo, MedSir, Menarini, Merck, Merus, Millennium, MSD, Nanobiotix, Nektar, Novartis, Odonate Therapeutics, Pfizer, Pharma Mar, Principia, PsiOxus, Puma, Regeneron, Rigontec, Roche, Sanofi, Sierra Oncology, Synthon, Taiho, Takeda, Tesaro, Transgene, Turning Point Therapeutics and Upshersmith.

    Dr Vibeke Strand discloses: Consultancy fees from AbbVie, Alpine, Alumis, Amgen Corporation, Aria, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Celltrion, ChemoCentryx, Endo, Equillium, Ermium, Genentech/Roche, Gilead, Glenmark, GSK, Horizon, Inmedix, Janssen, Kiniksa, Kypha, Lilly, Merck, MiMedx, Novartis, Pfizer, Priovant, R-Pharm, Regeneron, Rheos, Samsung, Sandoz, Sanofi, Scipher, Setpoint, SOFUSA, Spherix and Tonix.

    Content reviewer

    Angela Massey Hill, Pharm.D., CPh, RPh. has no financial interests/relationships or affiliations in relation to this activity.

    Touch Medical Director

    Adriano Boasso has no financial interests/relationships or affiliations in relation to this activity.

    USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

    Requirements for Successful Completion

    In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

    If you have questions regarding credit please contact cpdsupport@usf.edu.

    Accreditations

    Physicians

    This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

    USF Health designates this enduring material for a maximum of 0.75 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 CreditTM into European CME credit (ECMEC) should contact the UEMS (www.uems.eu).

    Advanced Practice Providers

    Physician Assistants may claim a maximum of 0.75 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

    The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

    Date of original release: 17 November 2022. Date credits expire: 17 November 2024.

    If you have any questions regarding credit please contact cpdsupport@usf.edu.

    This activity is CE/CME accredited

    To obtain the CE/CME credit(s) from this activity, please complete this post-activity test.

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    Topics covered in this activity

    Immunotherapy
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    This Activity Is Funded By:

    An independent medical education grant from AstraZeneca. This activity is jointly provided by USF Health and touchIME.

    The information provided by this CE activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CE to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals.

    Date of original release: 17 November 2022. Date credits expire: 17 November 2024.

    Claim Credit
    touchPANEL DISCUSSION
    Immunogenicity of immune checkpoint inhibitors: What are the implications for clinical practice?
    0.75 CE/CME credit
    Question 1/5
    Which of these statements about non-neutralizing antibodies against biologic drugs is correct?

    Non-neutralizing antibodies do not interfere with the binding of the biologic drug to its target and therefore they do not directly inhibit its pharmacodynamic activity; however, they can lower the drug’s systemic exposure by increasing the rate of drug clearance1 via immune complexes.2

    References

    1. Gunn GR, et al. Clin Exp Immunol. 2016;184:137–46. 
    2. Strand V, et al. Nat Rev Rheumatol. 2021;17:81–97.
    Question 2/5
    Your patient with cancer has started therapy with an ICI. Based on data on the use of biologic therapies in chronic inflammatory diseases, which of these factors do you expect to influence the immunogenicity of the monoclonal antibody used for therapy?

    ICI, immune checkpoint inhibitor.

    The immunogenic response to biologic therapies can be altered by concomitant use of immunosuppressive and antiproliferative agents such as methotrexate. The immunogenicity of biologic can also be affected by treatment-related factors, such as the dose and route of administration; drug-related factors, such as biologic sequence and structure; and patient-related factors, such as genetics, disease type and activity.

    Reference

    Strand V, et al. Nat Rev Rheumatol. 2021;17:81–97.

    Question 3/5
    Your patient is a 55-year-old man with a solid tumour and is enrolled in an open-label phase I clinical trial testing atezolizumab monotherapy in a new indication. His blood work has recently shown the presence of ADAs against atezolizumab. Based on available data, how would you expect this result to affect response to therapy?

    ADA, anti-drug antibody.

    A meta-analysis of 11 trials including 7,303 patients with solid tumours (lung, breast, renal, liver and urothelial cancers) found that the efficacy of atezolizumab was similar between patients who tested positive or negative for ADAs.

    Abbreviation

    ADA, anti-drug antibody.

    Reference

    Peters S, et al. Clin Transl Sci. 2022;15:141–57.

    Question 4/5
    Based on clinical trial data, what incidence of ADAs would you expect to see in your patients who are receiving treatment with durvalumab?

    ADA, anti-drug antibody.

    The maximum reported treatment-emergent ADA positive rate for durvalumab is 3%.

    Abbreviation

    ADA, anti-drug antibody.

    Reference

    FDA. Durvalumab PI. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/761069s029lbl.pdf (accessed 19 October 2022).

    Question 5/5
    Your patient, a 50-year-old male with a solid tumour receiving ICI therapy for the past 6 months, has shown tumour progression at his follow-up last week. What would you do to factor ADAs into the clinical decision-making process for this patient?

    ADA, anti-drug antibody; ICI, immune checkpoint inhibitor.

    ADA measurement is not standardized nor routinely conducted in oncology clinical practice; their analysis is generally conducted only in the early stages of drug development. 

    Abbreviation

    ADA, anti-drug antibody.

    Reference

    Borregón M, et al. Cancer Chemother Pharmacol. 2022;89:577–84.

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    This Activity Is Funded By:

    An independent medical education grant from AstraZeneca. This activity is jointly provided by USF Health and touchIME.

    The information provided by this CE activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CE to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals.

    Date of original release: 17 November 2022. Date credits expire: 17 November 2024.

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