Topics for Discussion

• Design, entry criteria and key efficacy and safety findings from the Phase II KEYNOTE-057 trial of pembrolizumab for patients with BCG-unresponsive, high-risk non-muscle-invasive urothelial bladder cancer (UBC) who are ineligible for or elected not to undergo cystectomy
• Recent FDA approval and integration into current care of pembrolizumab for high-risk non-muscle-invasive UBC that is unresponsive to BCG
• Key findings from trials supporting the FDA approvals of atezolizumab and pembrolizumab as first-line treatment for patients with metastatic UBC (mUBC) who are not eligible for chemotherapy
• Rationale for and clinical implications of the revision of FDA approvals of atezolizumab and pembrolizumab limiting their use for patients with locally advanced or metastatic UBC who have not received prior therapy, are not eligible for cisplatin-containing treatment and have low expression of PD-L1
• Results from the Phase III IMvigor130 trial of atezolizumab as monotherapy and in combination with chemotherapy versus chemotherapy alone for untreated locally advanced or metastatic UBC; clinical implications
• Emerging results from the Phase III JAVELIN Bladder 100 study demonstrating improved overall survival for patients receiving first-line maintenance therapy with avelumab
• Recent FDA breakthrough therapy designation for avelumab as first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
• Patient selection and indications for atezolizumab, avelumab, durvalumab, nivolumab and pembrolizumab for progressive metastatic disease
• Biologic rationale for targeting nectin-4 in patients with mUBC; structural components and mechanism of antitumor response of enfortumab vedotin
• Design, eligibility criteria and key findings from the pivotal Phase II EV-201 trial evaluating enfortumab vedotin for patients with locally advanced or metastatic UBC who previously received an immune checkpoint inhibitor and platinum-based chemotherapy
• Recent FDA approval and current clinical role of enfortumab vedotin for locally advanced or metastatic urothelial cancer
• Ongoing studies evaluating the use of enfortumab vedotin alone (EV-301) or in combination with other systemic therapies, including anti-PD-1/PD-L1 antibodies (EV-103)
• Spectrum and frequency of FGFR alterations in patients with mUBC
• Mechanism of action of and available efficacy and safety data supporting the recent FDA approval of erdafitinib for patients with locally advanced or metastatic UBC with susceptible FGFR3 or FGFR2 genetic alterations who have experienced disease progression on or after platinum-containing chemotherapy
• Appropriate integration of erdafitinib into current management paradigms
• Incidence and severity of adverse events with enfortumab vedotin and erdafitinib; optimal monitoring and management strategies

Target Audience
This activity has been designed to meet the educational needs of oncology nurses, nurse practitioners and clinical nurse specialists involved in the treatment of bladder cancer.

Learning Objectives and Goals
Upon completion of this activity, participants should be able to:

• Identify available clinical trial data supporting the use of immune checkpoint inhibitors for the treatment of urothelial bladder carcinoma (UBC) to determine the current utility of these agents in clinical practice.
• Develop an understanding of the recent revisions to the FDA approvals of atezolizumab and pembrolizumab limiting the use of these agents for patients with locally advanced or metastatic UBC who have not received prior therapy, are not eligible for cisplatin-containing treatment and have low expression of PD-L1, to ensure safety and appropriate administration.
• Review available clinical trial data evaluating the use of anti-PD-1/PD-L1 antibodies as maintenance therapy after first-line chemotherapy for patients with previously untreated metastatic UBC (mUBC), and consider the potential role of this approach in routine practice.
• Appraise available research data and ongoing clinical trials evaluating anti-PD-1/PD-L1 antibodies in combination with chemotherapy, targeted agents or other immunotherapeutic strategies for mUBC, and counsel appropriately selected patients about participation in active research protocols.
• Describe the frequency of fibroblast growth factor receptor (FGFR) abnormalities in patients with mUBC, and recognize the FDA approval of erdafitinib for individuals with advanced UBC and susceptible FGFR3 or FGFR2 genetic alterations whose disease has progressed during or after at least 1 line of platinum-containing chemotherapy.
• Develop an understanding of the mechanism of action of and pivotal clinical trial findings with enfortumab vedotin for previously treated locally advanced or metastatic UBC, and identify patients for whom treatment with this novel compound would be appropriate.
• Educate patients about the side effects and toxicities associated with approved therapies commonly employed in the management of UBC, and provide preventive strategies to reduce or ameliorate these toxicities.
• Identify opportunities to enhance the collaborative role of oncology nurses in the comprehensive biopsychosocial care of patients with UBC to optimize clinical and quality-of-life outcomes.

Accreditation Statement
USF Health is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.

A maximum of 1.5 contact hours may be earned by learners who successfully complete this nursing continuing professional development activity.

This activity is awarded 1.5 ANCC pharmacotherapeutic contact hours.



Participation Completion Requirements
To obtain a certificate of completion and receive credit for this event, nurses must attend the entire activity and return a completed Educational Assessment and Credit Form, which will be emailed to attendees after the event.

Oncology Nursing Certification Corporation (ONCC)/Individual Learning Needs Assessment (ILNA) Certification Information
The program content has been reviewed by the ONCC and is acceptable for recertification points. Learners must apply for CNE (NCPD) credit to utilize this program for ONCC certification or renewal. http://www.ResearchToPractice.com/Meetings/ONS2020/UrothelialBladderCarcinoma/ILNA

Unlabeled/Unapproved Uses Notice
There is no implied or real endorsement of any product by USF Health, Research To Practice (RTP) or the ANCC. Any off-label use as declared by the FDA will be identified.

Disclosure Policy
USF Health adheres to ACCME and ANCC standards regarding commercial support of continuing medical education. It is the policy of USF Health and Research To Practice that the faculty and planning committee disclose real or apparent conflicts of interest relating to the topics of this educational activity, that relevant conflict(s) of interest are resolved and also that speakers will disclose any unlabeled/unapproved use of drug(s) or device(s) during their presentation.

FACULTY — Ms Daskalova has no relevant conflicts of interest to disclose. The following faculty (and their spouses/partners) reported relevant conflicts of interest, which have been resolved through a conflict of interest resolution process:

Dr Balar — Consulting Agreements: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Janssen Biotech Inc, Merck, Nektar, Pfizer Inc, Seattle Genetics; Contracted Research: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Immunomedics Inc, Janssen Biotech Inc, Merck, Nektar, Pfizer Inc, Seattle Genetics. Dr O’Donnell — Consulting Agreement: Merck; Honoraria: Astellas, Atheneum Partners, FirstWord Publication, Genentech, a member of the Roche Group, Health Advances, Janssen Biotech Inc, Merck, Schlesinger Group, Seattle Genetics, The Dedham Group; Ownership Interest: Allergan, PrescriptIQ; Paid Travel: Astellas, Genentech, a member of the Roche Group, Janssen Biotech Inc, Merck, Seattle Genetics; Other: Janssen Biotech Inc, Nektar, National Institutes of Health. Ms Roethke — Advisory Committee: Astellas; Speakers Bureau: Astellas, Pfizer Inc.

MODERATOR — 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 commercial interests: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Adaptive Biotechnologies, Agendia Inc, Agios Pharmaceuticals Inc, Amgen Inc, Array BioPharma Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Biodesix Inc, bioTheranostics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Boston Biomedical Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, EMD Serono Inc, Exelixis Inc, Foundation Medicine, Genentech, a member of the Roche Group, Genmab, Genomic Health Inc, Gilead Sciences Inc, GlaxoSmithKline, Guardant Health, Halozyme Inc, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Kite, A Gilead Company, Lexicon Pharmaceuticals Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Merrimack Pharmaceuticals Inc, Myriad Genetic Laboratories Inc, Natera Inc, Novartis, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Prometheus Laboratories Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sandoz Inc, a Novartis Division, Sanofi Genzyme, Seattle Genetics, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, Teva Oncology, Tokai Pharmaceuticals Inc and Tolero Pharmaceuticals.

USF Health — USF Health CPD staff have no relevant conflicts of interest to disclose.

RTP CNE (NCPD) planning committee members, staff and reviewers — Planners, scientific staff and independent reviewers for RTP have no relevant conflicts of interest to disclose.

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

Contact Information
If you have questions regarding credit, please contact cpdsupport@usf.edu, or call 813-224-7860.

Supporters
This activity is supported by educational grants from Astellas and Seattle Genetics, Genentech, a member of the Roche Group, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, and Merck.