WIXLIB

Medical OncologistsJeremy Abramson, MDDirector, Center for LymphomaMassachusetts General HospitalAssociate Professor of MedicineHarvard Medical SchoolBoston, MassachusettsJohanna Bendell, MDChief Development OfficerDirector, Drug Development Unit NashvilleSarah Cannon Research InstituteTennessee OncologyNashville, TennesseeCarey K Anders, MDProfessor of MedicineMedical Director of the Duke Centerof Brain and Spine MetastasesDuke Cancer InstituteDurham, North CarolinaCarla Casulo, MDAssociate Professor of MedicineDivision of Hematology/OncologyDirector, Hematology/OncologyFellowship ProgramUniversity of RochesterWilmot Cancer InstituteNew York, New YorkStephen M Ansell, MD, PhDProfessor of MedicineChair, Lymphoma GroupMayo ClinicRochester, Minnesota

Medical OncologistsDaniel Catenacci, MDAssociate Professor, Department of MedicineSection of Hematology and OncologyDirector, Interdisciplinary GastrointestinalOncology ProgramAssistant Director, Translational ResearchComprehensive Cancer CenterThe University of Chicago Medical Center andBiological SciencesChicago, IllinoisRobert L Coleman, MDChief Scientific OfficerUS Oncology ResearchGynecologic OncologyThe Woodlands, TexasCourtney D DiNardo, MD, MSCEAssociate Professor, Department of LeukemiaDivision of Cancer MedicineThe University of Texas MD Anderson Cancer CenterHouston, TexasElisabeth I Heath, MDAssociate Center Director, Translational SciencesChair, Genitourinary Oncology Multidisciplinary TeamProfessor of Oncology and MedicineHartmann Endowed Chair for Prostate Cancer ResearchDirector, Prostate Cancer ResearchKarmanos Cancer InstituteWayne State University School of MedicineDetroit, Michigan

Medical OncologistsThomas J Herzog, MDPaul and Carolyn Flory ProfessorDeputy Director, University of CincinnatiCancer CenterVice-Chair, Quality and SafetyDepartment of Obstetrics and GynecologyUniversity of Cincinnati Medical CenterAssociate Director, GOG PartnersCincinnati, OhioJohn V Heymach, MD, PhDProfessor and ChairThoracic/Head and Neck Medical OncologyThe University of Texas MD Anderson Cancer CenterHouston, TexasBrian T Hill, MD, PhDDirector, Lymphoid Malignancy ProgramCleveland Clinic Taussig Cancer InstituteCleveland, OhioCaron Jacobson, MDAssistant Professor of MedicineHarvard Medical SchoolDana-Farber Cancer InstituteBoston, MassachusettsShaji K Kumar, MDMark and Judy Mullins Professor ofHematological MalignanciesConsultant, Division of HematologyProfessor of MedicineMayo ClinicRochester, MinnesotaJohn P Leonard, MDRichard T Silver Distinguished Professor ofHematology and Medical OncologySenior Associate Dean for Innovation and InitiativesExecutive Vice Chair, Joan and Sanford I WeillDepartment of MedicineWeill Cornell MedicineNew York, New York

Medical OncologistsSagar Lonial, MDChair and ProfessorDepartment of Hematology and Medical OncologyAnne and Bernard Gray Family Chair in CancerChief Medical OfficerWinship Cancer InstituteEmory University School of MedicineAtlanta, GeorgiaKathy D Miller, MDBallvé-Lantero ProfessorDivision of Hematology/OncologyAssociate Director for Clinical ResearchThe Indiana University Melvin and Bren SimonCancer CenterIndianapolis, IndianaJohn M Pagel, MD, PhDChief of Hematologic Malignancies ProgramCenter for Blood Disorders and Stem CellTransplantationSwedish Cancer InstituteSeattle, WashingtonPaul K Paik, MDAssociate Attending PhysicianClinical Director, Thoracic Oncology ServiceMemorial Sloan Kettering Cancer CenterNew York, New YorkDaniel P Petrylak, MDProfessor of Internal Medicine(Medical Oncology) and UrologyYale School of MedicineNew Haven, ConnecticutZofia Piotrowska, MD, MHSAssistant Professor of MedicineHarvard Medical SchoolMassachusetts General HospitalBoston, Massachusetts

Medical OncologistsNoopur Raje, MDDirector, Center for Multiple MyelomaMassachusetts General Hospital Cancer CenterProfessor of MedicineHarvard Medical SchoolBoston, MassachusettsPaul G Richardson, MDClinical Program Leader and Director ofClinical ResearchJerome Lipper Multiple Myeloma CenterDana-Farber Cancer InstituteRJ Corman Professor of MedicineHarvard Medical SchoolBoston, MassachusettsCharles J Ryan, MDProfessor of MedicineBJ Kennedy Chair in Clinical Medical OncologyDirector, Division of Hematology, Oncologyand TransplantationUniversity of MinnesotaMinneapolis, MinnesotaA Oliver Sartor, MDCE and Bernadine Laborde Professor forCancer ResearchMedical Director, Tulane Cancer CenterAssistant Dean for OncologyTulane Medical SchoolNew Orleans, LouisianaEytan M Stein, MDAssistant Attending PhysicianDirector, Program for Drug Development in LeukemiaLeukemia Service, Department of MedicineMemorial Sloan Kettering Cancer CenterNew York, New YorkMary-Ellen Taplin, MDProfessor of MedicineHarvard School of MedicineDana-Farber Cancer InstituteBoston, Massachusetts

Medical OncologistsKrishnansu S Tewari, MDProfessor and Division DirectorDivision of Gynecologic OncologyUniversity of California, IrvineIrvine, CaliforniaSara M Tolaney, MD, MPHAssociate DirectorSusan F Smith Center for Women’s CancersDirector of Clinical Trials, Breast OncologyDirector of Breast Immunotherapy Clinical ResearchSenior PhysicianBreast Oncology ProgramDana-Farber Cancer InstituteAssociate Professor of MedicineHarvard Medical SchoolBoston, MassachusettsJennifer Woyach, MDProfessorDivision of HematologyDepartment of Internal MedicineThe Ohio State University ComprehensiveCancer CenterColumbus, Ohio

Oncology Nurse PractitionersPaula J Anastasia, MN, RN, AOCNGYN Oncology Advanced Practice NurseUniversity of California, Los AngelesLos Angeles, CaliforniaKristen E Battiato, AGNP-CAdvanced Practice ProvidersMemorial Sloan Kettering Cancer CenterNew York, New YorkCourtney Arn, CNPThe James Cancer Hospital andSolove Research InstituteThe Ohio State UniversityColumbus, OhioKathy D Burns, RN, MSN, AGACNP-BC, OCNGU Medical OncologyCity of Hope Comprehensive Cancer CenterDuarte, CaliforniaMonica Averia, MSN, AOCNP, NP-COncology Nurse PractitionerUSC Norris Cancer CenterLos Angeles, CaliforniaGretchen Santos Fulgencio, MSN, FNP-BCUniversity of California, San FranciscoBerkeley, CaliforniaLesley Camille Ballance, MSN, FNP-BCSarah Cannon Center for Blood CancerTennessee OncologyNashville, TennesseeIlene Galinsky, NPSenior Adult Leukemia Program ResearchNurse PractitionerDana-Farber Cancer InstituteBoston, Massachusetts

Oncology Nurse PractitionersJacklyn Gideon, MSN, AGPCNP-BCAdvanced Practice ProviderLead Apheresis APPHematopoietic Cellular Therapy ProgramSection of Hematology/OncologyThe University of Chicago Medicine andBiological SciencesChicago, IllinoisKelly EH Goodwin, MSN, RN, ANP-BCThoracic Cancer CenterMassachusetts General HospitalBoston, MassachusettsCharise Gleason, MSN, NP-C, AOCNPAdvanced Practice Provider ChiefWinship Cancer Institute of Emory UniversityAdjunct Faculty, Nell Hodgson WoodruffSchool of NursingAtlanta, GeorgiaAllie Hershey, MSN, RN, ANP-BC, AOCNPOncology Nurse Practitioner, Breast OncologySusan F Smith Center for Women’s CancersDana-Farber Cancer InstituteBoston, MassachusettsSonia Glennie, ARNP, MSN, OCNSwedish Cancer Institute Center forBlood DisordersSeattle, WashingtonCorinne Hoffman, MS, APRN-CNP, AOCNPNurse Practitioner, HematologyThe James Comprehensive Cancer CenterThe Ohio State University Wexner Medical CenterColumbus, Ohio

Oncology Nurse PractitionersRobin Klebig, APRN, CNP, AOCNPNurse PractitionerAssistant Professor of MedicineDivision of HematologyMayo ClinicRochester, MinnesotaKelly Leonard, MSN, FNP-BCFamily Nurse PractitionerDana-Farber Cancer InstituteBoston, MassachusettsPatricia Mangan, RN, MSN, CRNP, APN, BCNurse Lead, Hematologic Malignancies andStem Cell Transplant ProgramsAbramson Cancer CenterUniversity of PennsylvaniaPhiladelphia, PennsylvaniaBrenda Martone, MSN, NP-BC, AOCNPNorthwestern MedicineNorthwestern Memorial HospitalChicago, IllinoisAlli McClanahan, MSN, APRN, ANP-BCNurse PractitionerDivision of HematologyMayo ClinicRochester, MinnesotaJessica Mitchell, APRN, CNP, MPHAssistant Professor of OncologyMayo Clinic College of Medicine and ScienceRochester, MinnesotaMollie Moran, APRN-CNP, AOCNPThe James Cancer Hospital and SoloveResearch InstituteThe Ohio State UniversityColumbus, Ohio

Oncology Nurse PractitionersTara Plues, APRN, MSNHematology and Medical OncologyCleveland ClinicCleveland, OhioKimberly A Spickes, MNSc, RN, APRN, OCN, ACNP-BCNurse PractitionerUAMS Division of Gynecologic OncologyUniversity of Arkansas for Medical SciencesLittle Rock, ArkansasTiffany A Richards, PhD, ANP-BC, AOCNPNurse PractitionerDepartment of Lymphoma/MyelomaThe University of TexasMD Anderson Cancer CenterHouston, TexasRonald Stein, JD, MSN, NP-C, AOCNPClinical Instructor of MedicineUSC Norris Comprehensive Cancer CenterLos Angeles, CaliforniaVictoria Sherry, DNP, CRNP, AOCNPOncology Nurse Practitioner for ThoracicMalignanciesAbramson Cancer CenterPerelman Center for Advanced MedicineUniversity of Pennsylvania Medical CenterFaculty, University of Pennsylvania School of NursingPhiladelphia, PennsylvaniaElizabeth Zerante, MS, AGACNP-BCAPN Inpatient Hematopoietic CellularTherapy ServiceUniversity of Chicago MedicineChicago, Illinois

Oncology Grand Rounds Nursing Webinar Series

13th Annual Oncology Grand RoundsOncology Nurse PractitionersCase Presentations Key patient-education issues Biopsychosocial considerations:– Family/loved ones– The bond that healsClinical InvestigatorsOncology Strategy New agents and regimens Predictive biomarkers Ongoing research and implications

th13Annual Oncology Grand RoundsA Complimentary NCPD Live Webinar SeriesHeld During the 46th Annual ONS CongressUrothelial Bladder CarcinomaWednesday, April 28, 202112:00 PM – 1:00 PM ETMedical OncologistsElisabeth I Heath, MDDaniel P Petrylak, MDOncology Nurse PractitionersMonica Averia, MSN, AOCNP, NP-CKathy D Burns, RN, MSN, AGACNP-BC, OCNModeratorNeil Love, MD

AgendaMs Averia: A 68-year-old woman with newly diagnosed metastatic bladder cancer –PD-L1 CPS 15Ms Burns: A frail 87-year-old man with relapsed metastatic bladder cancerMs Averia: An 81-year-old woman with relapsed, metastatic bladder cancerMs Burns: A 51-year-old man with metastatic bladder cancer and an FGFR3 mutation

Which of the following agents is now approved and commonly usedas maintenance therapy after first-line chemotherapy for metastaticurothelial bladder cancer?1. Pembrolizumab2. Avelumab3. Enfortumab vedotin4. Erdafitinib5. I don’t know

Case Presentation – A 68-year-old woman with newlydiagnosed metastatic bladder cancer – PD-L1 CPS 15(Part 1) Rheumatologist, married with daughter Summer 2020: Transferred from another hospital where she had beenadmitted for acute renal failure Diagnosed with metastatic urothelial bladder cancer– PD-L1 CPS: 15, PD-L1 IC: 5% 9-12/2020: Cisplatin/gemcitabine 3/2021 – present: Avelumab– Tolerating well, fatigueMs Averia

Case Presentation – A 68-year-old woman with newlydiagnosed metastatic bladder cancer – PD-L1 CPS 15(Part 2) Rheumatologist, married with daughter Summer 2020: Transferred from another hospital where she had beenadmitted for acute renal failure Diagnosed with metastatic urothelial bladder cancer– PD-L1 CPS: 15, PD-L1 IC: 5% 9-12/2020: Cisplatin/gemcitabine 3/2021 – present: Avelumab– Tolerating well, fatigue Symptom management phone calls multiple times weeklyMs Averia

Anti-PD-1/PD-L1 Antibodies: Mechanism of Action PD-1 expression on tumor-infiltrating lymphocytes is associated with decreased cytokine productionand effector function- Anti-PD-1 antibodies bind PD-1 receptors on T cells and disrupts negative signaling triggered byPD-L1/PD-L2 to restore T-cell antitumor function- Anti-PD-L1 antibodies bind PD-L1 receptorsIFNγIFNγRMHCTumor D-L1PD-1PD-L2Shp-2T cellShp-2PD-1CD28PD-1PD-1B7PD-L1PD-L2Dendriticcell

Current Treatment ParadigmsMetastatic Urothelial Ca Cisplatin eligible– gem/cis Cisplatin ineligible– immunotherapy (pembro or atezo) if PD-L1 – gem/carbo Chemotherapy unfit– immunotherapy (pembro or atezo) Platinum refractory– immunotherapy (pembro level 1 evidence)Courtesy of Peter H O’Donnell, MD

FDA Approves Avelumab for Urothelial CarcinomaMaintenance TreatmentPress Release – June 30, 2020“The Food and Drug Administration approved avelumab for maintenance treatment ofpatients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressedwith first-line platinum-containing chemotherapy.Efficacy of avelumab for maintenance treatment of UC was investigated in the JAVELINBladder 100 trial (NCT02603432), a randomized, multi-center, open-label trial that enrolled700 patients with unresectable, locally advanced or metastatic urothelial carcinoma that hadnot progressed with four to six cycles of first-line platinum-containing chemotherapy. Patientswere randomized (1:1) to receive either avelumab intravenously every 2 weeks plus bestsupportive care (BSC) or BSC alone. Treatment was initiated within 4-10 weeks after lastchemotherapy inoma-maintenance-treatment

N Engl J Med 2020;383:1218-30.

JAVELIN Bladder 100 Primary Endpoint: Overall SurvivalOverallPD-L1-positiveAvelumab21.4 moNEControl14.3 mo17.1 mo0.69(p 0.001)0.56(p 0.001)Hazard Ratio(p-value)Powles T et al. N Engl J Med 2020;383:1218-30.

FDA-Approved Immune Checkpoint Inhibitors for UBCAgentFDA approval date IndicationAvelumab6/30/2020 Maintenance treatment after first-line 20 BCG-unresponsive, high-risk NMIBC in patients ineligible for orelecting not to undergo cystectomyPembrolizumab*5/18/2017 Previously platinum-treated locally advanced or metastatic UBCAvelumab5/9/2017 Previously platinum-treated locally advanced or metastatic UBCDurvalumab5/1/2017FDA indication voluntarily withdrawnNivolumab2/2/2017 Previously platinum-treated locally advanced or metastatic UBCAtezolizumab*5/18/2016FDA indication voluntarily withdrawnNMIBC non-muscle-invasive bladder cancer* 6/9/2018: FDA limits use to locally advanced or metastatic UBC not eligible for cisplatin* 8/16/2018: FDA requires companion diagnostic for specific PD-L1 levels (pembrolizumab CPS 10, atezolizumab IC 5%);for patients not eligible for any platinum-containing therapy, indication is regardless of PD-L1 pprovals-safety-notifications

Voluntary Withdrawal of Durvalumab Indication for AdvancedBladder Cancer in the United StatesPress Release – February 22, 2021“The voluntary withdrawal of the durvalumab indication in the US for previously treated adultpatients with locally advanced or metastatic bladder cancer [was announced today]. Thisdecision was made in consultation with the Food and Drug Administration (FDA).In May 2017, durvalumab was granted accelerated approval in the US based on promisingtumor response rates and duration of response data from Study 1108, a Phase I/II trial thatevaluated the safety and efficacy of durvalumab in advanced solid tumors, includingpreviously treated bladder cancer. Continued approval was contingent on results from theDANUBE Phase III trial in the 1st-line metastatic bladder cancer setting, which did not meet itsprimary endpoints in 2020. The withdrawal is aligned with FDA guidance for evaluatingindications with accelerated approvals that did not meet post-marketing requirements, as partof a broader industry-wide evaluation. This withdrawal does not impact the indication outsidethe US and does not impact other approved durvalumab indications within or outside the ladder-indication.html

Voluntary Withdrawal of Atezolizumab Indication for AdvancedBladder Cancer in the United StatesPress Release – March 7, 2021The voluntary withdrawal of the atezolizumab indication in the US for prior platinum-treatedmetastatic urothelial carcinoma was announced on March 7, 2021. “This decision was made inconsultation with the US Food and Drug Administration (FDA) as part of an industry-wide review ofaccelerated approvals with confirmatory trials that have not met their primary endpoint(s) andhave yet to gain regular approvals.”“Atezolizumab was granted accelerated approval in 2016 for the treatment of prior-platinumtreated mUC based on the results from the IMvigor210 study (Cohort 2). Continued approval forthis indication was contingent upon the results of IMvigor211, the original PMR [post-marketingrequirements] for the prior-platinum mUC indication. This study did not meet its primary endpointof overall survival in the PD-L1 high patient population. Subsequently, the FDA designated theIMvigor130 study as the PMR which will still continue until the final analysis. However, as thetreatment landscape in prior-platinum (second-line) mUC has rapidly evolved with the emergenceof new treatment options, [the manufacturer] is voluntarily withdrawing this indication inrecognition of the principles of the Accelerated Approval ecentriq-u

AgendaMs Averia: A 68-year-old woman with newly diagnosed metastatic bladder cancer –PD-L1 CPS 15Ms Burns: A frail 87-year-old man with relapsed metastatic bladder cancerMs Averia: An 81-year-old woman with relapsed, metastatic bladder cancerMs Burns: A 51-year-old man with metastatic bladder cancer and an FGFR3 mutation

Case Presentation – A frail 87-year-old man withrelapsed metastatic bladder cancer (Part 1) Active, retired architect and attorney; married with children Summer 2020: Diagnosed with metastatic urothelial bladder cancer– PD-L1 status: Unknown, PIK3CA mutation– Frail, rising creatinine Pembrolizumab x 3-4 doses à PD Enfortumab vedotinMs Burns

Case Presentation – A frail 87-year-old man withrelapsed metastatic bladder cancer (Part 2) Active, retired architect and attorney; married with childrenMs Burns Summer 2020: Diagnosed with metastatic urothelial bladder cancer– PD-L1 status: Unknown, PIK3CA mutation– Frail, rising creatinine Pembrolizumab x 3-4 doses à PD Enfortumab v

Wayne State University School of Medicine Detroit, Michigan Daniel P Petrylak, MD Professor of Internal Medicine (Medical Oncology) and Urology Yale School of Medicine New Haven, Connecticut Oncology Nurse Practitioners Monica Averia, MSN, AOCNP, NP-C Oncology Nurse Practitioner USC Norris Cancer Center Los Angeles, California