P2-01 Tar-200 in Patients With Bacillus Calmette–guérin-Unresponsive High-Risk Non–muscle-Invasive Bladder Cancer: Results From Sunrise-1 Study

You have accessJournal of UrologyParadigm-shifting, Practice-changing Clinical Trials in Urology (P2)1 May 2024P2-01 TAR-200 IN PATIENTS WITH BACILLUS CALMETTE–GUÉRIN-UNRESPONSIVE HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER: RESULTS FROM SUNRISE-1 STUDY Andrea Necchi, Siamak Daneshmand, Giuseppe Simone, Evanguelos Xylinas, David S. Morris, Daniel Zainfeld, Taek Won Kang, Justin T. Matulay, Laurence H. Belkoff, Karel Decaestecker, Harm Arentsen, Shalaka Hampras, Christopher J. Cutie, Hussein Sweiti, Katharine Stromberg, Jason Martin, Abhijit Shukla, Michiel S. van der Heijden, Philipp Spiegelhalder, and Joseph M. Jacob Andrea NecchiAndrea Necchi , Siamak DaneshmandSiamak Daneshmand , Giuseppe SimoneGiuseppe Simone , Evanguelos XylinasEvanguelos Xylinas , David S. MorrisDavid S. Morris , Daniel ZainfeldDaniel Zainfeld , Taek Won KangTaek Won Kang , Justin T. MatulayJustin T. Matulay , Laurence H. BelkoffLaurence H. Belkoff , Karel DecaesteckerKarel Decaestecker , Harm ArentsenHarm Arentsen , Shalaka HamprasShalaka Hampras , Christopher J. CutieChristopher J. Cutie , Hussein SweitiHussein Sweiti , Katharine StrombergKatharine Stromberg , Jason MartinJason Martin , Abhijit ShuklaAbhijit Shukla , Michiel S. van der HeijdenMichiel S. van der Heijden , Philipp SpiegelhalderPhilipp Spiegelhalder , and Joseph M. JacobJoseph M. Jacob View All Author Informationhttps://doi.org/10.1097/01.JU.0001015816.87470.c9.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Patients (pts) with Bacillus Calmette–Guérin (BCG)-unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC) are at high risk of disease progression and have limited bladder-sparing treatment (tx) options. TAR-200, an intravesical drug delivery system, is designed to provide sustained release of gemcitabine in the bladder over 3 wks. SunRISe-1 (NCT04640623) is an ongoing, randomized, phase 2b study assessing efficacy and safety of TAR-200+cetrelimab (anti-PD1) (Cohort 1 C1), TAR-200 alone (C2), or cetrelimab alone (C3) in pts with BCG-unresponsive HR NMIBC with carcinoma in situ (CIS), with or without papillary disease, who are ineligible for or refusing radical cystectomy. As of Amendment 4, TAR-200 alone is also being assessed in pts with papillary disease only (C4). We report results from C2. METHODS: Eligible pts aged ≥18 yr had histologically confirmed carcinoma in situ (CIS)±papillary disease (high-grade Ta, any T1) after adequate BCG, with last dose of BCG ≤12 mo prior to CIS diagnosis, and ECOG performance status 0-2. TAR-200 was dosed every 3 wks through Wk 24, then every 12 wks until Wk 96. Response was assessed by cystoscopy and centrally assessed urine cytology, CT/MRI, and bladder biopsy (at Wks 24, 48, and as clinically indicated). The primary end point was overall complete response (CR) rate. Secondary end points included duration of response (DOR), overall survival, safety, and tolerability. RESULTS: At data cutoff (Jan 2, 2024), 85 pts (median age, 71 yr; range, 40-88; 33% with concurrent papillary disease) received TAR-200 monotherapy. 58 pts were efficacy evaluable. Centrally confirmed CR rate was 83% (95% CI, 71-91) by urine cytology and/or biopsy. The estimated 1 yr DOR rate is 75% (95% CI 50-88), with median follow-up in responders of 30 wks (range, 14-140); 41 of 48 responders (85%) remain in CR at data cutoff. 47 of 48 (98%) of CRs were achieved at first disease assessment at wk 12. CR rate by investigator assessment (86%; 95% CI, 75-94) correlated strongly with central results. 61 pts (72%) had tx-related adverse events (TRAEs); most common (≥10%) were pollakiuria (35%), dysuria (29%), micturition urgency (15%), and urinary tract infection (15%). 7 pts (8%) had grade ≥3 TRAEs; 4 (5%) had serious TRAEs; 4 (5%) had TRAEs leading to discontinuation. No tx-related deaths were reported. CONCLUSIONS: In SunRISe-1, TAR-200 monotherapy is associated with a clinically meaningful, high, centrally confirmed CR rate, durable responses, and a favorable benefit-risk profile in pts with BCG-unresponsive CIS. Source of Funding: Janssen Research & Development © 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 Andrea Necchi More articles by this author Siamak Daneshmand More articles by this author Giuseppe Simone More articles by this author Evanguelos Xylinas More articles by this author David S. Morris More articles by this author Daniel Zainfeld More articles by this author Taek Won Kang More articles by this author Justin T. Matulay More articles by this author Laurence H. Belkoff More articles by this author Karel Decaestecker More articles by this author Harm Arentsen More articles by this author Shalaka Hampras More articles by this author Christopher J. Cutie More articles by this author Hussein Sweiti More articles by this author Katharine Stromberg More articles by this author Jason Martin More articles by this author Abhijit Shukla More articles by this author Michiel S. van der Heijden More articles by this author Philipp Spiegelhalder More articles by this author Joseph M. Jacob More articles by this author Expand All Advertisement PDF downloadLoading ...