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Faculty & Disclosures

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    Faculty & Disclosures
    Dr Vadim Koshkin

    University of California San Francisco, San Francisco, CA, USA

    Dr Vadim Koshkin is a genitourinary medical oncologist at the University of California San Francisco (UCSF) Department of Medicine, San Francisco, CA, USA, with interests in clinical and translational research. read more

    Dr Koshkin joined the faculty at UCSF in 2018, focusing on the care of patients with genitourinary malignancies and building the bladder cancer programme. Dr Koshkin also serves as the site committee co-chair of the Molecular Imaging & Radionuclide Therapy Site Committee.

    Dr Koshkin’s research interests focus on clinical trials, targeted agents and biomarkers in bladder cancer, as well as radioligand therapies and imaging in bladder and prostate cancer. He is co-leading the Urothelial Cancer Network to Investigate Therapeutic Experiences (UNITE) study, a large, multi-institutional, retrospective study of patients with advanced urothelial cancer treated with novel antibody–drug conjugates and targeted agents. 

    Dr Koshkin is the author of numerous articles and book chapters, including first author publications in the Journal of Clinical Oncology, Clinical Cancer Research, Cancer and the Journal for ImmunoTherapy of Cancer. He has also presented his research at numerous national meetings. 

    Dr Koshkin is the recipient of multiple awards, including the Prostate Cancer Foundation Young Investigator Award.

    Dr Vadim Koshkin discloses: Advisory board or panel fees from Astellas, EMD Serono, GLG Pharma, Guidepoint, Janssen, Merck, Pfizer and Seagen. Grants/research support from Eli Lilly, Gilead, Janssen, Merck, Nektar Therapeutics, Novartis, Seagen and Taiho.
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    Focus Questions
    What are the current unmet needs for patients with locally advanced or metastatic urothelial carcinoma?
    What are the current unmet needs for patients with locally advanced or metastatic urothelial carcinoma?
    What is the status of biomarkers currently used in urothelial carcinoma?
    What is the status of biomarkers currently used in urothelial carcinoma?
    What is the rationale for targeting HER2 in urothelial carcinoma?
    What is the rationale for targeting HER2 in urothelial carcinoma?
    How is HER2 expression assessed in urothelial carcinoma, and what are the unmet needs in this area?
    How is HER2 expression assessed in urothelial carcinoma, and what are the unmet needs in this area?
    Does HER2 overexpression imply more aggressive disease biology, and is HER2 IHC a prognostic marker in patients with urothelial carcinoma?
    Does HER2 overexpression imply more aggressive disease biology, and is HER2 IHC a prognostic marker in patients with urothelial carcinoma?
    What HER2-targeted approaches are being investigated in urothelial carcinoma?
    What HER2-targeted approaches are being investigated in urothelial carcinoma?
    What is the latest evidence for these HER2-targeted treatments in urothelial carcinoma?
    What is the latest evidence for these HER2-targeted treatments in urothelial carcinoma?
    How do you think HER2-targeted treatments may impact clinical practice in the future, and where will they fit in the current treatment paradigm?
    How do you think HER2-targeted treatments may impact clinical practice in the future, and where will they fit in the current treatment paradigm?
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    Is HER2 targeting on the horizon in urothelial carcinoma?

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    Dr Vadim Koshkin is a genitourinary medical oncologist at the University of California San Francisco (UCSF) Department of Medicine, San Francisco, CA, USA, with interests in clinical and translational research. read more

    Dr Koshkin joined the faculty at UCSF in 2018, focusing on the care of patients with genitourinary malignancies and building the bladder cancer programme. Dr Koshkin also serves as the site committee co-chair of the Molecular Imaging & Radionuclide Therapy Site Committee.

    Dr Koshkin’s research interests focus on clinical trials, targeted agents and biomarkers in bladder cancer, as well as radioligand therapies and imaging in bladder and prostate cancer. He is co-leading the Urothelial Cancer Network to Investigate Therapeutic Experiences (UNITE) study, a large, multi-institutional, retrospective study of patients with advanced urothelial cancer treated with novel antibody–drug conjugates and targeted agents. 

    Dr Koshkin is the author of numerous articles and book chapters, including first author publications in the Journal of Clinical Oncology, Clinical Cancer Research, Cancer and the Journal for ImmunoTherapy of Cancer. He has also presented his research at numerous national meetings. 

    Dr Koshkin is the recipient of multiple awards, including the Prostate Cancer Foundation Young Investigator Award.

    Dr Vadim Koshkin discloses: Advisory board or panel fees from Astellas, EMD Serono, GLG Pharma, Guidepoint, Janssen, Merck, Pfizer and Seagen. Grants/research support from Eli Lilly, Gilead, Janssen, Merck, Nektar Therapeutics, Novartis, Seagen and Taiho.

    Learning Objectives

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

    • Discuss the clinical significance of HER2 expression in patients with urothelial carcinoma and considerations for molecular testing
    • Evaluate emerging HER2-targeting treatment strategies for patients with urothelial carcinoma and the latest clinical evidence
    Overview

    In this interview, Dr Vadim Koshkin answers a series of questions focused on the potential for targeting HER2 in the treatment of urothelial carcinoma, including the rationale for HER2 as a target, approaches to HER2 testing, the latest data on emerging HER2-targeted therapies and the potential implications for future clinical practice.

    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, urologists and pathologists involved in the management of urothelial carcinoma.

    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

    Dr Vadim Koshkin discloses: Advisory board or panel fees from Astellas, EMD Serono, GLG Pharma, Guidepoint, Janssen, Merck, Pfizer and Seagen. Grants/research support from Eli Lilly, Gilead, Janssen, Merck, Nektar Therapeutics, Novartis, Seagen and Taiho.

    Content reviewer

    Alicia Canalejo, APRN has no financial interests/relationships or affiliations in relation to this activity.

    Touch Medical Contributors

    Hannah Fisher 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 0.5 credit hours 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 0.5 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: 24 January 2024. Date credits expire: 24 January 2025.

    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

    Genitourinary Cancer / Bladder Cancer
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    This Activity Is Funded By:

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

    The information provided by this CME 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 CME 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: 24 January 2024. Date credits expire: 24 January 2025.

    Claim Credit
    touchFOCUS
    Is HER2 targeting on the horizon in urothelial carcinoma?
    0.5 CE/CME credit
    Question 1/5
    What is the prevalence of HER2 expression (HER2-positive [IHC3+ or IHC 2+/FISH+] or HER2-low [IHC1+ or IHC2+/FISH-]) in patients with advanced urothelial carcinoma?

    FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry.

    A large study investigating HER2 expression using standardized laboratory methods found that 44% of UC samples have some degree of HER2 expression (HER2-positive or HER2-low). 

    Abbreviations

    HER2, human epidermal growth factor receptor 2; UC, urothelial carcinoma.

    Reference

    Koshkin VS, et al. J Clin Oncol. 2023;41(Suppl. 6):556.

    Question 2/5
    Your patient is a 71-year-old female with metastatic urothelial carcinoma. You suggest she undergoes a molecular test with the aim of developing a tailored treatment plan for her. Which of the following would you consider performing to assess HER2 expression?

    ERBB2, receptor tyrosine-protein kinase erbB-2; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; NGS, next-generation sequencing.

    IHC is the current method to assess HER2 protein expression, whereas ISH/FISH and NGS are used to determine ERBB2 gene amplification. There is currently no standardized method for assessing and defining HER2 status in patients with UC.

    Abbreviations

    ERBB2, receptor tyrosine-protein kinase erbB-2; FISH, fluorescence ISH; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ISH, in situ hybridization; NGS, next-generation sequencing; UC, urothelial carcinoma.

    Reference

    Scherrer E, et al. Front Oncol. 2022;12:1011885.

    Question 3/5
    Which of the following statements about investigational HER2-targeted therapies for patients with urothelial carcinoma is true?

    ADC, antibody–drug conjugate; HER2, human epidermal growth factor receptor 2; ORR, objective response rate; TKI, tyrosine kinase inhibitor.

    ADCs as a monotherapy and in combination therapy with immune checkpoint inhibitors are a promising avenue in the treatment of HER2-expressing UC.1–4 Conventional anti-HER2 therapies such as antibodies and TKIs have failed to show clinical benefits in metastatic UC.1

    Abbreviations

    ADC, antibody–drug conjugate; HER2, human epidermal growth factor receptor 2; TKI, tyrosine kinase inhibitor; UC, urothelial carcinoma.

    References

    1. Sheng X, et al. J Clin Oncol. 2023; doi: 10.1200/JCO.22.02912.
    2. Xu H, et al. J Clin Oncol. 2022;40(Suppl. 16):4519.
    3. Meric-Bernstam F, et al. J Clin Oncol. 2024;42:47–58.
    4. J Galsky MD, et al. J Clin Oncol. 2022;40(Suppl. 6):438.
    Question 4/5
    Your patient has HER2-positive, advanced urothelial carcinoma (IHC 3+) that has progressed after treatment with gemcitabine plus cisplatin. You are discussing the possibility of entering them into a clinical trial of disitamab vedotin monotherapy. They are curious about the expected efficacy they can expect from the treatment based on their disease characteristics. How would you counsel them?

    HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry.

    Data from a pooled analysis of two trials of disitamab vedotin in patients with HER2-positive (IHC 2+ or 3+) locally advanced or metastatic UC with progression after at least one previous line of systemic chemotherapy reported an ORR of 50.5%.

    Abbreviations

    HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ORR, objective response rate; UC, urothelial carcinoma.

    Reference

    Sheng X, et al. J Clin Oncol. 2023:JCO.22.02912.

    Question 5/5
    In a phase I trial of trastuzumab deruxtecan + nivolumab combination therapy in patients with HER2-expressing UC with progression following platinum-based chemotherapy, what ORR has been reported?

    HER2, human epidermal growth factor receptor 2; ORR, objective response rate; UC, urothelial carcinoma

    A phase I trial of trastuzumab deruxtecan + nivolumab reported an ORR of 36.7% in patients with high HER2-expressing UC (IHC 2+ or 3+) with progression following prior platinum-based chemotherapy (n=30).

    Abbreviations

    HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ORR, objective response rate; UC, urothelial carcinoma.

    Reference

    Galsky MD, et al. J Clin Oncol. 2022;40(Suppl. 6):438.

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    This Activity Is Funded By:

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

    The information provided by this CME 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 CME 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: 24 January 2024. Date credits expire: 24 January 2025.

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