Cases From The Community — Urologic Oncology Investigators Provide Perspectives on the Optimal Management of Urothelial Bladder Cancer

Room 265-268
Satellite Symposia

Information

Learning Objectives:

    • Consider available data supporting the use of anti-PD-1 antibody therapy for high-risk, non-muscleinvasive bladder cancer (NMIBC) that is unresponsive to BCG and determine how this strategy can be appropriately integrated into current care.
    • Evaluate the recent FDA approval of adjuvant anti-PD-1 antibody therapy for patients with high-risk muscle-invasive bladder cancer (MIBC) and consider the current role of this treatment strategy.
    • Recognize how biologic and patient-specific factors influence the selection and sequencing of treatment for patients with metastatic urothelial bladder carcinoma (UBC).
    • Review available clinical trial evidence with immune checkpoint inhibitors as monotherapy or as maintenance after platinum-based chemotherapy in the treatment of newly diagnosed metastatic UBC and determine the current utility of these agents in clinical practice.
    • Recall pivotal clinical trial findings leading to the FDA approval of novel compounds with unique mechanisms of action for previously treated locally advanced or metastatic UBC and identify patients for whom treatment with these approaches would be appropriate.
    • Implement a plan of care to recognize and manage side effects and toxicities associated with recently approved and emerging systemic therapies for advanced or metastatic UBC.
    • Develop an understanding of the biologic rationale for, available research findings with and ongoing studies evaluating promising investigational agents and strategies in patients with NMIBC, MIBC and metastatic UBC.

MODULE 1: Available Data with and Ongoing Investigation of Novel Agents and Strategies for Non-Muscle-Invasive Bladder Cancer (NMIBC)

1. Historical management approaches for patients with BCG-unresponsive or refractory

2. Efficacy and safety findings after extended follow-up from the KEYNOTE-057 trial supporting the FDA approval of pembrolizumab monotherapy for high-risk NMIBC unresponsive or refractory to BCG therapy; selection of patients for pembrolizumab therapy

3. Biologic rationale for the investigation of anti-PD-1/PD-L1 antibodies in combination with BCG for NMIBC; ongoing Phase III trials evaluating this approach (eg, ALBAN, POTOMAC, KEYNOTE-676, CheckMate 7G8)

4. Ongoing and planned studies evaluating other novel approaches (eg, enfortumab vedotin, erdafitinib, nadofaragene firadenovec) for BCG-unresponsive NMIBC

MODULE 2: The Role of Immune Checkpoint Inhibitors as Adjuvant and Neoadjuvant Therapy for Muscle-Invasive Bladder Cancer (MIBC)\r\n\r\n1. Clinical and biologic factors that confer a high risk of recurrence in patients with MIBC; historical role of adjuvant therapy

2. Design, eligibility criteria and key efficacy and safety data from the Phase III CheckMate 274 trial comparing nivolumab to placebo after radical surgery for high-risk MIBC

3. Recent FDA approval of adjuvant nivolumab and identification of appropriate candidates for treatment

4. Rates of pathologic complete response and other clinically relevant endpoints achieved in early trials evaluating neoadjuvant anti-PD-1/PD-L1 antibody therapy for resectable MIBC

5. Ongoing research on the feasibility of combining anti-PD-1/PD-L1 antibodies with other systemic options (eg, chemotherapy, other immunotherapy) in the neoadjuvant and adjuvant settings

6. Emerging results from cohort H of the EV-103 study evaluating neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with MIBC

MODULE 3: The Current and Future Front-Line Management of Metastatic Urothelial Bladder Carcinoma (mUBC)

1. Current role of atezolizumab and pembrolizumab as first-line treatment for mUBC; importance of chemotherapy eligibility and PD-L1 status in selecting patients for this strategy

2. Key efficacy and safety data with maintenance avelumab after front-line chemotherapy for mUBC; appropriate incorporation into patient care

3. Biologic rationale for and available data with anti-PD-1/PD-L1 antibodies combined with anti-CTLA-4 antibodies for previously untreated mUBC

4. Ongoing Phase III trials (eg, CheckMate 901, NILE) evaluating dual checkpoint inhibitor therapy alone or in combination with chemotherapy

5. Findings from the Phase II EV-103 study evaluating first-line pembrolizumab in combination with enfortumab vedotin for mUBC; ongoing Phase III evaluation and potential clinical role\r\n6. Preliminary data from the Phase I/II NORSE study of erdafitinib in combination with the investigational anti-PD-1 antibody cetrelimab for patients with previously untreated mUBC with FGFR3 or FGFR2 genetic alterations who are not eligible for cisplatin

MODULE 4: The Selection and Sequencing of Therapy for Relapsed/Refractory mUBC

1. Key efficacy and safety findings with enfortumab vedotin for progressive mUBC (eg, EV-301 trial, EV-201 cohort 2)

2. Key efficacy and safety findings from the Phase II TROPHY U-01 trial leading to the recent FDA approval of sacituzumab govitecan for progressive mUBC

3. Emerging results from cohort 3 of the TROPHY U-01 trial combining sacituzumab govitecan and pembrolizumab

4. Spectrum and frequency of FGFR alterations in patients with mUBC; published efficacy and safety data with erdafitinib for patients with mUBC and susceptible FGFR3 or FGFR2 genetic alterations

5. Optimal integration of enfortumab vedotin, sacituzumab govitecan and erdafitinib into therapy for progressive mUBC\r\nIncidence, severity and management of adverse events reported with enfortumab vedotin, sacituzumab govitecan or erdafitinib

6. Frequency of HER2 expression in UBC; mechanism of action of disitamab vedotin and available data and ongoing evaluation for patients with HER2-positive disease

7. Other promising agents and strategies under investigation for mUBC (eg, trastuzumab deruxtecan, futibatinib, infigratinib, cabozantinib)

Target Audience

This activity has been designed to meet the educational needs of medical and radiation oncologists, urologists and other allied healthcare professionals involved in the treatment of bladder cancer.

There is no registration fee for this event. For the in-person symposium in New Orleans, preregistration is required as seating is limited.

A CME credit form will be given to each participant at the conclusion of the activity.

Accreditation Statement

Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Credit Designation Statement

Research To Practice designates this live activity for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Content Validation and Disclosures

Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest will have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. Financial disclosures will be provided in meeting course materials.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

Supporters

This activity is supported by educational grants from Astellas and Seagen Inc, AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, and Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC.