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    Faculty & Disclosures
    Prof. Brian I Rini

    Vanderbilt University Medical Center, Nashville, TN, USA

    Brian I Rini, MD, FASCO, is chief of clinical trials at Vanderbilt-Ingram Cancer Center (VICC) and Ingram professor of medicine at Vanderbilt University, where he leads kidney cancer clinical research efforts and the expansion of cancer clinical research operations. read more

    Prof. Rini has authored over 300 publications covering genitourinary cancer, most notably renal cell carcinoma. He has been lead investigator of several phase III clinical trials, which have led to FDA approval.

    Prof. Rini has spoken at numerous seminars and given multiple invited lectures, locally, nationally and internationally on genitourinary cancers and their treatment. He is a member of the American Society of Clinical Oncology, Kidney Cancer Association and Society for Immunotherapy of Cancer, with leadership positions in these organizations. He recently completed a term as a member and immediate past chair of the Oncologic Drugs Advisory Committee.

    Disclosures

    Prof. Brian I Rini discloses: Advisory board or panel fees from Alkermes, Aravive, Arrowhead Pharmaceuticals, Athenex Pharmaceuticals, Aveo Oncology, Bristol Myers Squibb, Corvus Pharmaceuticals, Debiopharm, Eisai, EUSA Pharma, Genentech, HiberCell, Merck, Nikang Therapeutics, Pfizer, Surface Oncology and Synthorx. Consultancy fees from Alkermes, Aravive, Arrowhead Pharmaceuticals, Athenex Pharmaceuticals, Aveo Oncology, Bristol Myers Squibb, Corvus Pharmaceuticals, Debiopharm, Eisai, EUSA Pharma, Genentech, HiberCell, Merck, Nikang Therapeutics, Pfizer, Surface Oncology and Synthorx. Grants/research support from ADC Therapeutics, Adela, Aravive, Arcus Biosciences, Arrowhead Pharmaceuticals, AstraZeneca, Aveo Oncology, Bristol Myers Squibb, Daiichi Sankyo, Dracen Pharmaceuticals, Dragonfly Therapeutics, Exelixis, Genentech, Gilead, HiberCell, Incyte, Janssen, Merck, Pfizer, Pionyr Immunotherapeutics, POINT Biopharma, Strata Oncology, Surface Oncology, Tempus and VasGene Therapeutics. Stock/shareholder (self-managed) PTC Therapeutics.
    Prof. Elizabeth Plimack

    Fox Chase Cancer Center,
    Philadelphia, PA, USA

    Elizabeth Plimack is a professor of medical oncology and deputy director of Fox Chase Cancer Center, USA. She is an expert on the treatment of genitourinary malignancies, with a focus on bladder and kidney cancers. read more

    Prof. Plimack received her undergraduate degree from Yale University, USA and completed her MD degree and residency in internal medicine at the New York University School of Medicine, USA. She went on to complete a medical oncology fellowship at the MD Anderson Cancer Center, and received a Masters in patient-based biologic research from the University of Texas Graduate School of Biomedical Science, USA.

    Prof. Plimack’s research effort is directed towards the discovery of novel therapeutic approaches and predictive biomarkers for patients with bladder and kidney cancers. She has extensive clinical trial experience with targeted therapy, immunotherapy and novel combination therapies. Prof. Plimack serves on the National Comprehensive Cancer Network guidelines panels for bladder cancer, chairs the scientific advisory board of the Bladder Cancer Advocacy Network and is an elected member of the American Society of Clinical Oncology (ASCO) board of directors (2020–2024), who elected her as treasurer for 2023–2024. Prof. Plimack has mentored numerous students, residents and fellows, and has been among the faculty at the annual American Association for Cancer Research/ASCO Methods in Clinical Cancer Research workshop since 2022.

    Disclosures

    Prof. Elizabeth Plimack discloses: Advisory board or panel fees from Astellas, AstraZeneca, Aveo, Calithera, EMD Serono, Exelixis, Genentech, IMV, Janssen, MEI Pharma, Merck, Pfizer, Regeneron, Seagen and Signatera. Consultancy fees from AstraZeneca and Infinity Pharmaceuticals. Grants/research support from Astellas, Bristol Myers Squibb, Genentech and Merck.
    Prof. Thomas Powles

    Barts Cancer Centre, St Bartholomew’s Hospital, London, UK

    Thomas Powles, MBBS, MRCP, MD is a professor of urology cancer at the University of London and director of Barts Cancer Centre, which is one of the UK’s largest cancer centres. He trained as an oncologist at Imperial College London, UK. read more

    Prof. Powles has had a prominent role in the development of biomarkers and new drug strategies in urology cancer. This includes multiple EMA and FDA approvals. He has led a number of clinical trials (including 11 randomized phase III trials) and translational oncology projects that have appeared in major journals.

    Prof. Powles has over 300 peer-reviewed publications. He has presented data at plenary sessions at key meetings, including American Society of Clinical Oncology (ASCO) 2020, and was awarded the bladder cancer award at ASCO Genitourinary Cancers in 2018. He has an active role on social media, with over 50,000 listens to his podcasts and over 3,000 followers on Twitter.

    Prof. Powles leads the European Society for Medical Oncology (ESMO) guidelines for renal and bladder cancer and was the track chair for non-prostate genitourinary cancer in 2021 (Paris). He previously participated in the steering committee for the educational and scientific tracks for the ESMO meetings; this includes co-chairing ESMO Immuno-Oncology 2019–2021.

    Prof. Thomas Powles discloses: Consultancy fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Pfizer, Roche and Seagen. Grants/research support from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Open Health, Pfizer, Roche and Seagen.
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    Immunotherapy-based combinations for advanced/metastatic renal cell carcinoma: What have we learned from ASCO GU 2023?

    Faculty Podcast Featured
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    Learning Objectives

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

    • Evaluate the latest efficacy and safety data for immune checkpoint inhibitor-based combinations in the treatment of advanced or metastatic RCC
    • Summarize the latest data on the use of biomarkers to predict response to immune checkpoint inhibitor-based combinations
    • Explain how the latest data on the use of immune checkpoint inhibitor-based combinations for the treatment of advanced or metastatic RCC may be implemented in clinical practice
    Overview

    In this activity, a renal cell carcinoma (RCC) expert reviews key data on immune checkpoint inhibitor (ICI)-based regimens for RCC from the ASCO GU 2023 Congress and discusses with two additional leading experts how these data may apply in clinical practice.

    This activity was filmed following the ASCO GU 2023 Congress (San Francisco, CA, USA, 16–18 February 2023).

    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, oncology surgeons and radiologists involved in the management of patients with RCC.

    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 financial relationships are listed below. All individuals not listed have no relevant financial relationships.

    Faculty 

    Prof. Brian I Rini discloses: Advisory board or panel fees from Alkermes, Aravive, Arrowhead Pharmaceuticals, Athenex Pharmaceuticals, Aveo Oncology, Bristol Myers Squibb, Corvus Pharmaceuticals, Debiopharm, Eisai, EUSA Pharma, Genentech, HiberCell, Merck, Nikang Therapeutics, Pfizer, Surface Oncology and Synthorx. Consultancy fees from Alkermes, Aravive, Arrowhead Pharmaceuticals, Athenex Pharmaceuticals, Aveo Oncology, Bristol Myers Squibb, Corvus Pharmaceuticals, Debiopharm, Eisai, EUSA Pharma, Genentech, HiberCell, Merck, Nikang Therapeutics, Pfizer, Surface Oncology and Synthorx. Grants/research support from ADC Therapeutics, Adela, Aravive, Arcus Biosciences, Arrowhead Pharmaceuticals, AstraZeneca, Aveo Oncology, Bristol Myers Squibb, Daiichi Sankyo, Dracen Pharmaceuticals, Dragonfly Therapeutics, Exelixis, Genentech, Gilead, HiberCell, Incyte, Janssen, Merck, Pfizer, Pionyr Immunotherapeutics, POINT Biopharma, Strata Oncology, Surface Oncology, Tempus and VasGene Therapeutics. Stock/shareholder (self-managed) PTC Therapeutics.

    Prof. Elizabeth Plimack discloses: Advisory board or panel fees from Astellas, AstraZeneca, Aveo, Calithera, EMD Serono, Exelixis, Genentech, IMV, Janssen, MEI Pharma, Merck, Pfizer, Regeneron, Seagen and Signatera. Consultancy fees from AstraZeneca and Infinity Pharmaceuticals. Grants/research support from Astellas, Bristol Myers Squibb, Genentech and Merck.

    Prof. Thomas Powles discloses: Consultancy fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Pfizer, Roche and Seagen. Grants/research support from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Open Health, Pfizer, Roche and Seagen.

    Content reviewer

    Claude Bassil, MD, FACP, FASN has no financial interests/relationships or affiliations in relation to this activity.

    Touch Medical Director

    Sadaf Kazi and Sola Neunie have 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 1.0 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 1.0 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 April 2023. Date credits expire: 24 April 2024.

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

    This activity is CE/CME accredited

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

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    Topics covered in this activity

    Renal Cancer / Genitourinary Cancer / Immunotherapy
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    This Activity Is Funded By:

    An independent medical education grant from Merck & Co. Inc. and Exelixis 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 April 2023. Date credits expire: 24 April 2024.

    Claim Credit
    touchCONGRESS
    Immunotherapy-based combinations for advanced/metastatic renal cell carcinoma: What have we learned from ASCO GU 2023?
    1.0 CE/CME credit
    Question 1/4
    Based on the recent subset analysis of the COSMIC-313 clinical trial, which patients with untreated advanced or metastatic RCC achieved the longest progression-free survival with the triplet therapy cabozantinib + nivolumab + ipilimumab?

    IMDC, International Metastatic RCC Database Consortium; RCC, renal cell carcinoma; VEGF, vascular endothelial growth factor.

    COSMIC-313 is an ongoing trial assessing the efficacy and safety of the C+N+I triplet therapy in patients who are defined by the IMDC as intermediate- or poor-risk RCC.1 While C+N+I significantly improved PFS in the overall population vs placebo (P+N+I),2 subgroup analyses suggested that the treatment benefit was primarily restricted to the intermediate-risk group (C+N+I vs P+N+I, 17.9 [95% CI, 14.1–NE] vs 11.3 [8.4–15.3] months; poor-risk group, 9.5 [8.3–15.8] vs 11.2 [6.0–14.2] months).3

    Abbreviations

    C, cabozantinib; CI, confidence interval; I, ipilimumab; IMDC, International Metastatic RCC Database Consortium; N, nivolumab; NE, not evaluable; P, placebo; PFS, progression-free survival; RCC, renal cell carcinoma.

    References

    1. ClinicalTrials.gov. NCT03937219. Available at: clinicaltrials.gov/ct2/show/NCT03937219 (accessed April 2023).
    2. Choueiri TK, et al. Presented at: ESMO Congress 2022, Paris, France. 9–13 September 2022. Abstr LBA8.
    3. Powles T, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 605.
    Question 2/4
    You are treating a patient with nivolumab and wish to analyse liquid biopsies to predict their likelihood of response. Based on the I-RENE trial, which of the following might suggest a potential clinical benefit from nivolumab?

    IL, interleukin; MDSC, myeloid-derived suppressor cell; miRNA, microRNA.

    Preliminary data from liquid biopsies analysed using multiparametric flow cytometry in the I-RENE trial indicate that clinical benefit of N seems to cluster with a boost in effector T cells and Ki67. Levels of monocytic MDSCs remain stable, while miRNA induction is associated with non-response. IL-8 levels do not associate with any response.

    Abbreviations

    IL, interleukin; MDSC, myeloid-derived suppressor cell; miRNA, microRNA; N, nivolumab.

    Reference

    Verzoni E, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 712.

    Question 3/4
    The histology report for a new patient indicates that they have advanced chromophobe RCC. Taking into consideration recent data presented at ASCO GU 2023, and the latest understanding of the disease, what should you do next?

    ASCO GU, American Society of Clinical Oncology Genitourinary Cancers Symposium; ccRCC, clear cell RCC; IO, immuno-oncology; PD-L1, programmed cell death ligand 1; RCC, renal cell carcinoma.

    A retrospective analysis of real-world data from the International Metastatic RCC Database Consortium of patients with advanced ChRCC or ccRCC who received IO-based therapies (dual IO or IO+VEGF-targeted therapy) in the first-line setting reported that OS and TTF was shorter in patients with ChRCC vs patients with ccRCC (median OS: 24.7 vs 50.5 months; p<0.001) and TTF (median TTF: 4.5 vs 11.0 months; p<0.001).1

    Patients’ and oncologists’ preferences for advanced RCC treatment are determined mainly by the efficacy (survival gain) but also by the HRQoL provided.2 With no clear evidence for improved survival for IO-based therapy in patients with ChRCC,1 the primary consideration to discuss with patients is impact on HRQoL.2

    Abbreviations

    ccRCC, clear cell RCC; ChRCC, chromophobe RCC; HRQoL, health-related quality of life; IO, immuno-oncology; OS, overall survival; RCC, renal cell carcinoma; TTF, time to treatment failure; VEGF, vascular endothelial growth factor.

    References

    1. Labaki C, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 654.
    2. Fernández O, et al. Front Oncol. 2022;11:773366.
    Question 4/4
    You have been treating a patient with advanced RCC with nivolumab + ipilimumab for the last 8 months. Based on data presented at ASCO GU 2023, and assuming toxicities are manageable, when would you consider initiating a treatment-free period?

    ASCO GU, American Society of Clinical Oncology Genitourinary Cancers Symposium; CR, complete response; PR, partial response; RCC, renal cell carcinoma; VEGF, vascular endothelial growth factor.

    Prescribing information for nivolumab indicates treatment up to 2 years or until disease progression or unacceptable toxicities.1 However, three studies from ASCO GU 2023, considering the impact of earlier initiation of treatment-free periods on patients with RCC, concluded that reductions in treatment time with IO-based therapies do not materially impact patients’ overall survival.2–4 A recently published retrospective study of patients with mRCC discontinuing nivolumab for reasons other than disease progression further concluded that patients whose initial treatment duration was <12 months or who did not achieve PR/CR had a greater risk of progression.5

    Abbreviations

    ASCO GU, American Society of Clinical Oncology Genitourinary Cancers Symposium; CR, complete response; IO, immuno-oncology; mRCC, metastatic RCC; PR, partial response; RCC, renal cell carcinoma.

    References

    1. FDA. Nivolumab PI. Available at:  www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s112lbl.pdf (accessed April 2023).
    2. Atkins MB, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 604.
    3. Yoo JH, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 625.
    4. George L, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 672.
    5. Bimbatti D, et al. Front Oncol. 2022;12:960751.
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    This Activity Is Funded By:

    An independent medical education grant from Merck & Co. Inc. and Exelixis 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 April 2023. Date credits expire: 24 April 2024.

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