Join us on Wednesday, July 21^st for this CME/MOC-accredited webinar
5:00 PM – 6:00 PM ET

Not an official event of the 2021 ASCO Annual Meeting. Not sponsored, endorsed, or accredited by ASCO^®, CancerLinQ^®, or Conquer Cancer^® the ASCO Foundation.

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.

MODULE 1: Optimal Application of Immune Checkpoint Inhibitors in the Treatment of Urothelial Bladder Cancer (UBC)

• Current role of immune checkpoint inhibitors in the management of nonmetastatic UBC
• Design, entry criteria and key efficacy and safety findings from the Phase II KEYNOTE-057 trial leading to the FDA approval of pembrolizumab for patients with BCG-unresponsive, high-risk non-muscle invasive UBC who are ineligible for or elected not to undergo cystectomy
• Optimal integration of pembrolizumab monotherapy into current treatment algorithms for patients with BCG-unresponsive non-muscle-invasive UBC
• Rationale for clinical investigations combining an anti-PD-1/PD-L1 antibody with BCG for patients with non-muscle invasive UBC
• Mechanism of action of sasanlimab; ongoing Phase III CREST trial of sasanlimab in combination with BCG for patients with high-risk non-muscle invasive UBC
• Other ongoing Phase III trials (eg, CheckMate 7G8, ALBAN, POTOMAC, KEYNOTE-676) evaluating immune checkpoint inhibitors in combination with BCG for individuals with newly diagnosed, high-risk BCG-naïve or BCG-pretreated non-muscle invasive UBC
• Utility of anti-PD-1/PD-L1 antibodies as neoadjuvant or adjuvant therapy for patients with muscle-invasive bladder cancer (MIBC)
• Initial efficacy and safety results from the Phase III CheckMate 274 trial comparing adjuvant nivolumab to placebo in patients who underwent radical surgery for high-risk MIBC
• Rationale for the negative findings reported in the Phase III IMvigor010 trial of adjuvant atezolizumab versus observation in MIBC
• Current nonprotocol role, if any, of concurrent chemoradiotherapy with an immune checkpoint inhibitor for localized MIBC; design, eligibility criteria and key endpoints of the ongoing Phase III SWOG-S1806 trial of chemoradiotherapy with atezolizumab in this setting
• Ongoing Phase III Studies of anti-PD-1/PD-L1 antibodies alone or in combination with other agents as neoadjuvant or adjuvant treatment for high-risk MIBC (eg, IMvigor011, NIAGARA, CA045-009, AMBASSADOR)
• Spectrum, frequency and severity of immunotherapy-related toxicities; optimal prevention and management strategies
• Genomic landscape in localized MIBC after neoadjuvant chemotherapy; frequency of targetable gene alterations for adjuvant therapy

MODULE 2: Selection and Sequencing of Available Therapies for Metastatic UBC

• Clinical, biologic and practical factors influencing the selection and sequencing of available therapies for patients with metastatic UBC
• Published efficacy and safety outcomes with atezolizumab or pembrolizumab in combination with chemotherapy as first-line therapy for patients with locally advanced or metastatic UBC
• Clinical implications of the recent withdrawal of atezolizumab from the treatment armamentarium for patients with pretreated UBC; negative survival results from the Phase III IMvigor211 trial
• Rationale for the FDA designation of the Phase III IMvigor130 trial evaluating atezolizumab with chemotherapy as the post-marketing requirement to confirm the atezolizumab’s clinical benefit in PD-L1-high advanced UBC
• Implications of the withdrawal of the durvalumab indication for pretreated patients with locally advanced or metastatic bladder cancer; final analysis of the results from the Phase III DANUBE trial
• Results from the Phase III JAVELIN Bladder 100 trial of first-line maintenance therapy with avelumab in combination with best supportive care (BSC) for patients with locally advanced or metastatic UBC; recent FDA approval of first-line avelumab maintenance
• Optimal approach to the management of patients who develop metastatic UBC on or after immune checkpoint inhibitor-based therapy for non-muscle invasive UBC or MIBC; clinical utility of rechallenging with an anti-PD-1/PD-L1 antibody in this setting
• Incidence of and biologic rationale for the use of targeted therapies directed at TROP2, nectin-4 or FGFR in progressive metastatic UBC
• Mechanism of action of and published data leading to the recent FDA approval of sacituzumab govitecan for patients with locally advanced or metastatic urothelial cancer who have received a platinum-based chemotherapy regimen and a PD-1/PD-L1 inhibitor (TROPHY-U-01 trial); optimal integration into current management algorithms
• Design, eligibility criteria and key endpoints of the ongoing Phase III TROPiCS trial comparing sacituzumab govitecan to single-agent treatment of physician’s choice in locally advanced or metastatic UBC with disease progression after a prior platinum-based regimen and an immune checkpoint inhibitor
• Optimal monitoring and management strategies for the toxicities (eg, infusion-related reactions, GI events, hypersensitivity) associated with sacituzumab govitecan
• Efficacy and safety findings from the pivotal Phase II EV-201 trial leading to the FDA approval of enfortumab vedotin in patients with locally advanced or metastatic UBC; primary results from the cohort of cisplatin-ineligible patients with platinum-naïve, locally advanced or metastatic disease who have received PD-1/PD-L1 inhibitors (Cohort 2)
• Key findings from the Phase III EV-301 study of enfortumab vedotin versus chemotherapy in pretreated locally advanced or metastatic UBC; management of adverse events (eg, hyperglycemia, ocular toxicities, peripheral neuropathy) associated with enfortumab vedotin
• Mechanism of action of and available data supporting the 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 chemotherapy
• Appropriate integration of erdafitinib into current management paradigms; incidence and severity of adverse events (eg, hyperphosphatemia, ocular toxicities, stomatitis) associated with erdafitinib

MODULE 3: New Directions in the Management of UBC

• Available data from the Phase I/II CheckMate 032 trial of nivolumab alone or in combination with ipilimumab in the cohort of patients with advanced UBC
• Ongoing Phase III trials (eg, CheckMate 901, NILE) evaluating anti-PD-1/PD-L1 antibodies in combination with other systemic therapies as first-line therapy for patients with unresectable locally advanced or metastatic UBC
• Design, eligibility criteria and key endpoints of the ongoing Phase III PROOF 302 trial of the oral FGFR inhibitor infigratinib as adjuvant therapy for patients with MIBC harboring susceptible FGFR3 alterations
• Published research findings and ongoing evaluations of other FGFR-targeted agents (eg, pemigatinib, rogaratinib, vofatamab, LY3076226, futibatinib) in UBC
• Clinical rationale for the ongoing evaluation of enfortumab vedotin in combination with an immune checkpoint inhibitor as neoadjuvant therapy for cisplatin-eligible patients with MIBC (KEYNOTE-B15/EV-304)
• Potential role of the antibody-drug conjugate sacituzumab govitecan in heavily pretreated metastatic UBC
• Biologic rationale for the ongoing evaluations of the multi-receptor tyrosine kinase inhibitor cabozantinib in combination with one or more anti-PD-1/PD-L1 antibodies in UBC (eg, ABATE, ARCADIA, PemCab, ICONIC)
• Emerging targets (eg, ICOS, ATR) and other novel agents (eg, feladilimab, berzosertib) and strategies in clinical development for patients with UBC

Target Audience
This program is intended for medical oncologists, hematology-oncology fellows and other allied healthcare professionals involved in the treatment of bladder cancer.

Learning Objectives

• Compare and contrast the available clinical trial evidence with immune checkpoint inhibitors in the treatment of urothelial bladder carcinoma (UBC) to determine the current utility of these agents in clinical practice.
• Appraise available research data and ongoing clinical trials evaluating anti-PD-1/PD-L1 antibodies alone or in combination with other systemic therapies for UBC, and counsel appropriately selected patients about participation in active protocols.
• Review published clinical trial data leading to the FDA approval of erdafitinib for patients 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, and determine how this agent may be appropriately integrated into clinical practice.
• Recall 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.
• Evaluate the recent FDA approval of the novel antibody-drug conjugate sacituzumab govitecan, and optimally integrate this agent into the care of patients with advanced UBC who have experienced disease relapse on chemotherapy and an immune checkpoint inhibitor.
• Develop an understanding of the biologic rationale for, available research findings with and ongoing studies evaluating promising investigational agents and strategies for UBC.

CME Credit Form
CME and ABIM MOC credit form links will be emailed to each participant within 5 days 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 1 AMA PRA Category 1 Credit^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

American Board of Internal Medicine (ABIM) — Maintenance of Certification (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1 Medical Knowledge MOC point in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information. For those clinicians wishing to receive ABIM MOC credit for attending, you will receive an email after the event with instructions.

Disclosure Policy
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant conflicts of interest, which have been mitigated through a conflict of interest mitigation process:

Dr Grivas — Advisory Committee and Consulting Agreements: 4D Pharma PLC, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Dyania Health, EMD Serono Inc, Exelixis Inc, Genentech, a member of the Roche Group, Genzyme Corporation, Gilead Sciences Inc, GlaxoSmithKline, Heron Therapeutics, Immunomedics Inc, Infinity Pharmaceuticals Inc, Janssen Biotech Inc, Merck, Mirati Therapeutics, Pfizer Inc, QED Therapeutics, Regeneron Pharmaceuticals Inc, Seagen Inc; Research Funding to Institution: Bavarian Nordic, Bristol-Myers Squibb Company, Clovis Oncology, Debiopharm Group, GlaxoSmithKline,Immunomedics Inc, Kure It Cancer Research,Merck, Mirati Therapeutics, Pfizer Inc, QED Therapeutics; Data and Safety Monitoring Board/Committee: Bristol-Myers Squibb Company. Dr Petrylak — Consulting Agreements: Advanced Accelerator Applications, Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bicycle Therapeutics, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Clovis Oncology, Exelixis Inc, Incyte Corporation, Janssen Biotech Inc, Lilly, Mirati Therapeutics, Monopteros Therapeutics, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Regeneron Pharmaceuticals Inc, Roche Laboratories Inc, Seagen Inc, UroGen Pharma; Contracted Research: Advanced Accelerator Applications, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BioXcel Therapeutics Inc, Bristol-Myers Squibb Company, Clovis Oncology, Eisai Inc, Endocyte Inc, Genentech, a member of the Roche Group, Innocrin Pharmaceuticals Inc, Lilly, Medivation Inc, a Pfizer Company, Merck, Mirati Therapeutics, Novartis, Pfizer Inc, Progenics Pharmaceuticals Inc, Replimune, Roche Laboratories Inc, Sanofi Genzyme, Seagen Inc; Ownership Interest: Bellicum Pharmaceuticals Inc, Tyme Inc. Dr Siefker-Radtke — Advisory Committee: AstraZeneca Pharmaceuticals LP, Basilea Pharmaceutica Ltd, Bristol-Myers Squibb Company, Genentech, a member of the Roche Group, IDEAYA Biosciences, Immunomedics Inc, Janssen Biotech Inc, Merck Sharp & Dohme Corp, Mirati Therapeutics, Nektar, Seagen Inc, Taiho Oncology Inc; Contracted Research: Basilea Pharmaceutica Ltd, Bristol-Myers Squibb Company, Janssen Biotech Inc, Merck Sharp & Dohme Corp, Nektar; Speakers Bureau (Nonpromotional): Janssen Biotech 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 companies: AbbVie Inc, Adaptive Biotechnologies Corporation, Agios Pharmaceuticals Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Eisai Inc, Epizyme Inc, Exact Sciences Inc, Exelixis Inc, Five Prime Therapeutics Inc, Foundation Medicine, Genentech, a member of the Roche Group, Gilead Sciences Inc, GlaxoSmithKline, Grail Inc, Halozyme Inc, Helsinn Healthcare SA, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Novartis, Novocure Inc, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sanofi Genzyme, Seagen Inc, Sumitomo Dainippon Pharma Oncology Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, TG Therapeutics Inc, Turning Point Therapeutics Inc and Verastem Inc.

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.