An interim analysis of a phase ii clinical study of intravesical photo dynamic therapy in patients with bcg-unresponsive non-muscle invasive bladder cancer (nmibc) carcinoma in-situ (cis)

You have accessJournal of UrologyCME1 Apr 2023MP63-01 AN INTERIM ANALYSIS OF A PHASE II CLINICAL STUDY OF INTRAVESICAL PHOTO DYNAMIC THERAPY IN PATIENTS WITH BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) CARCINOMA IN-SITU (CIS) Girish Kulkarni, Kyle Richards, Peter C. Black, Ricardo Rendon, Joseph Chin, Neal Shore, Gautam Jayram, Eugene Kramolowsky, Daniel Saltzstein, Piyush Agarwal, Laurence Belkoff, Michael O'Donnell, Ashish M. Kamat, Alexandre Zlotta, Michael A. S. Jewett, Donald Lamm, Victor DeGruttola, Arkady Mandel, Roger J. Dumoulin-White, and Wassim Kassouf Girish KulkarniGirish Kulkarni More articles by this author , Kyle RichardsKyle Richards More articles by this author , Peter C. BlackPeter C. Black More articles by this author , Ricardo RendonRicardo Rendon More articles by this author , Joseph ChinJoseph Chin More articles by this author , Neal ShoreNeal Shore More articles by this author , Gautam JayramGautam Jayram More articles by this author , Eugene KramolowskyEugene Kramolowsky More articles by this author , Daniel SaltzsteinDaniel Saltzstein More articles by this author , Piyush AgarwalPiyush Agarwal More articles by this author , Laurence BelkoffLaurence Belkoff More articles by this author , Michael O'DonnellMichael O'Donnell More articles by this author , Ashish M. KamatAshish M. Kamat More articles by this author , Alexandre ZlottaAlexandre Zlotta More articles by this author , Michael A. S. JewettMichael A. S. Jewett More articles by this author , Donald LammDonald Lamm More articles by this author , Victor DeGruttolaVictor DeGruttola More articles by this author , Arkady MandelArkady Mandel More articles by this author , Roger J. Dumoulin-WhiteRoger J. Dumoulin-White More articles by this author , and Wassim KassoufWassim Kassouf More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003321.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Novel therapies are required for BCG-unresponsive, high risk non-muscle invasive bladder cancer. We report the interim results of a Phase II Clinical Study of intravesical Photo Dynamic Therapy (PDT) in patients with BCG-unresponsive carcinoma in-situ (CIS) (+/- papillary disease). METHODS: 41 of planned 125 patients have been treated with two study treatments (Day 0 and Day 180) consisting of an intravesical instillation of the photosensitizer (TLD-1433 (0.70 mg/cm2)) followed by activation with a 520 nm intravesical laser under general anesthesia (Study Device TLC-3200) to a total of 90 J/cm2 of laser light. We have included 3 patients treated in a preceding Phase Ib NMIBC clinical study assessing the safety of TLD-1433 PDT, who were treated at the same parameters, for a total of 44 patients. The primary outcome was complete response (CR) at any point in time. The secondary outcome was duration of CR, after initial CR. A tertiary objective was safety, evaluated by the incidence and severity of grade ≥4 adverse events (AEs) that did not resolve within 450 days post treatment. All AEs were tracked for resolution to 450 days. Patients with a negative cystoscopy and positive cytology were defined as indeterminate response (IR), as these patients remain under investigation for lower and upper tract urothelial carcinoma. RESULTS: Primary and secondary outcomes for the first 41 patients plus the 3 Phase Ib patients (n=44) are listed in the table. For evaluable patients, a primary outcome of 55.3% CR at any point in time was achieved, with a secondary outcome of duration of response of 21% CR at 450 days. There have been eight serious adverse events (SAE) identified (2 grade II (tachycardia, hematuria), 3 grade III (acute kidney injury, cellulitis), 2 grade IV (urosepsis, depression/anxiety) and 1 grade V (cardiac arrest)). None of the SAEs were deemed to be directly related to PDT, per the Data Safety Monitoring Board. CONCLUSIONS: The interim data supports that PDT provides a viable treatment option for patients with BCG unresponsive CIS (±papillary disease) with an acceptable safety profile. Source of Funding: Theralase Technologies Inc © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e871 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Girish Kulkarni More articles by this author Kyle Richards More articles by this author Peter C. Black More articles by this author Ricardo Rendon More articles by this author Joseph Chin More articles by this author Neal Shore More articles by this author Gautam Jayram More articles by this author Eugene Kramolowsky More articles by this author Daniel Saltzstein More articles by this author Piyush Agarwal More articles by this author Laurence Belkoff More articles by this author Michael O'Donnell More articles by this author Ashish M. Kamat More articles by this author Alexandre Zlotta More articles by this author Michael A. S. Jewett More articles by this author Donald Lamm More articles by this author Victor DeGruttola More articles by this author Arkady Mandel More articles by this author Roger J. Dumoulin-White More articles by this author Wassim Kassouf More articles by this author Expand All Advertisement PDF downloadLoading ...