P2-02 PIVOTAL RESULTS FROM BOND-003: A PHASE 3, SINGLE-ARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR THE TREATMENT OF HIGH RISK, BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU

You have accessJournal of UrologyParadigm-shifting, Practice-changing Clinical Trials in Urology (P2)1 May 2024P2-02 PIVOTAL RESULTS FROM BOND-003: A PHASE 3, SINGLE-ARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR THE TREATMENT OF HIGH RISK, BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU Mark D. Tyson, Edward Uchio, Jong-Kil Nam, Donald L. Lamm, Trinity J. Bivalacqua, Neal D. Shore, Wassim Kassouf, Gary D. Steinberg, Peter C. Black, Ashish M. Kamat, Hiroshi Kitamura, James M. Burke, and Roger Li Mark D. TysonMark D. Tyson , Edward UchioEdward Uchio , Jong-Kil NamJong-Kil Nam , Donald L. LammDonald L. Lamm , Trinity J. BivalacquaTrinity J. Bivalacqua , Neal D. ShoreNeal D. Shore , Wassim KassoufWassim Kassouf , Gary D. SteinbergGary D. Steinberg , Peter C. BlackPeter C. Black , Ashish M. KamatAshish M. Kamat , Hiroshi KitamuraHiroshi Kitamura , James M. BurkeJames M. Burke , and Roger LiRoger Li View All Author Informationhttps://doi.org/10.1097/01.JU.0001015816.87470.c9.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Considerable unmet medical need exists for highly effective, well-tolerated, readily available, and durable treatment options for patients with High Risk, BCG-Unresponsive, Non-Muscle Invasive Bladder Cancer with Carcinoma in Situ (HR BCG-UR NMIBC with CIS). Cretostimogene grenadenorepvec is a serotype-5 oncolytic adenovirus designed to selectively replicate in bladder cancer cells with alterations in the retinoblastoma pathway. Additionally, the virus is engineered to express the GM-CSF transgene, resulting in a potent oncolytic immunotherapy mechanism of action. Cretostimogene recently received both Food and Drug Administration (FDA) Fast Track and Breakthrough Therapy Designations for HR BCG-UR NMIBC with CIS. METHODS: 112 adults with histologically confirmed HR BCG-UR NMIBC with CIS were enrolled. Participants had previously received adequate BCG and were HR BCG-UR by the FDA definition. Cretostimogene treatment consisted of 6 weekly doses during the induction phase, followed by 3 weekly maintenance cycles at months 3, 6, 9, 12 and 18. Participants were eligible for repeat induction therapy at month 3, if persistent HG Ta or CIS was noted at biopsy. Response assessments included serial cystoscopy, urine cytology, axial imaging, and mandatory mapping biopsy at month 12, with centralized review of all pathology. The primary outcome measure was Complete Response (CR) at any time. Other secondary and exploratory endpoints were also assessed. RESULTS: The CR rate at any time in the evaluable population is 75.2% (79/105) (95% CI 65-83%). 83% of responders have ongoing response at 12 months. 26 participants underwent repeat induction and 53.8% (14/26) subsequently converted to CR. The radical cystectomy-free proportion is 92.3% at 12 months. The median DOR has not been reached but exceeds 9 months. Cretostimogene is well-tolerated and adverse events related to therapy are predominantly Grade 1 or 2 local genitourinary events. Further mature data will be presented at the AUA Annual Meeting. CONCLUSIONS: The efficacy and safety of intravesical cretostimogene for the treatment of BCG-UR, HR NMIBC with CIS, with or without Ta/T1 tumors, compares favorably to existing FDA-approved therapies. Further investigation of this promising monotherapy, as well as future combinations, is warranted and may address a considerable unmet need for bladder cancer patients. Source of Funding: CG Oncology © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5S2May 2024Page: e1 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Mark D. Tyson More articles by this author Edward Uchio More articles by this author Jong-Kil Nam More articles by this author Donald L. Lamm More articles by this author Trinity J. Bivalacqua More articles by this author Neal D. Shore More articles by this author Wassim Kassouf More articles by this author Gary D. Steinberg More articles by this author Peter C. Black More articles by this author Ashish M. Kamat More articles by this author Hiroshi Kitamura More articles by this author James M. Burke More articles by this author Roger Li More articles by this author Expand All Advertisement PDF downloadLoading ...