LBA02-03 FIRST RESULTS FROM SunRISE-1 IN PATIENTS WITH BCG UNRESPONSIVE HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER RECEIVING TAR-200 IN COMBINATION WITH CETRELIMAB, TAR-200, OR CETRELIMAB ALONE

You have accessJournal of UrologyCME1 Apr 2023LBA02-03 FIRST RESULTS FROM SunRISE-1 IN PATIENTS WITH BCG UNRESPONSIVE HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER RECEIVING TAR-200 IN COMBINATION WITH CETRELIMAB, TAR-200, OR CETRELIMAB ALONE Siamak Daneshmand, Michiel S van der Heijden, Joseph M Jacob, Andrea Necchi, Evanguelos Xylinas, David S Morris, Philip Spiegelhalder, Daniel Zainfeld, Taek Won Kang, Justin T Matulay, Laurence H Belkoff, Karel Decaestecker, Harm Arentsen, Shalaka Hampras, Shu Jin, Christopher J Cutie, Hussein Sweiti, Katherine Stromberg, Jason Martin, and Giuseppe Simone Siamak DaneshmandSiamak Daneshmand More articles by this author , Michiel S van der HeijdenMichiel S van der Heijden More articles by this author , Joseph M JacobJoseph M Jacob More articles by this author , Andrea NecchiAndrea Necchi More articles by this author , Evanguelos XylinasEvanguelos Xylinas More articles by this author , David S MorrisDavid S Morris More articles by this author , Philip SpiegelhalderPhilip Spiegelhalder More articles by this author , Daniel ZainfeldDaniel Zainfeld More articles by this author , Taek Won KangTaek Won Kang More articles by this author , Justin T MatulayJustin T Matulay More articles by this author , Laurence H BelkoffLaurence H Belkoff More articles by this author , Karel DecaesteckerKarel Decaestecker More articles by this author , Harm ArentsenHarm Arentsen More articles by this author , Shalaka HamprasShalaka Hampras More articles by this author , Shu JinShu Jin More articles by this author , Christopher J CutieChristopher J Cutie More articles by this author , Hussein SweitiHussein Sweiti More articles by this author , Katherine StrombergKatherine Stromberg More articles by this author , Jason MartinJason Martin More articles by this author , and Giuseppe SimoneGiuseppe Simone More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003361.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Patients (pts) with high-risk non–muscle-invasive bladder cancer (HR NMIBC) unresponsive to intravesical BCG have limited treatment (tx) options. TAR-200 is a novel intravesical drug delivery system that provides sustained local release of gemcitabine into the bladder. Cetrelimab (CET) is an anti-PD1 agent. SunRISe-1 is an ongoing ph 2 study evaluating efficacy and safety of TAR-200 + CET (Cohort 1 [C1]), TAR-200 alone (C2), or CET alone (C3) in BCG-unresponsive pts with HR NMIBC (carcinoma in situ [CIS]) who are ineligible for or decline radical cystectomy. We report preliminary results from SunRISe-1, providing data from C2 and C3. METHODS: Pts ≥18 y with histologically confirmed CIS±papillary disease (T1, high-grade Ta) who completed adequate BCG ≤12 mo before enrollment and with ECOG performance status 0-2 were randomized to C1, C2, or C3. TAR-200 was dosed Q3W through Wk 24, then Q12W until Wk 96. CET was dosed through Wk 78. Cystoscopy, centrally read urine cytology, CT/MRI, and TURBT (bladder biopsy) were done at baseline and prespecified time points to assess disease response. The primary end point is overall complete response (CR) rate at any time point. Secondary end points include duration of response (DOR), overall survival, PK, quality of life, safety, and tolerability. Initial results are reported; updated data (≈40 pts) will be included in the presentation. RESULTS: As of data cutoff (May 25, 2022), 13 pts in C2 and 13 in C3 (median 71.5 y [range 51-88]) received tx. Efficacy evaluable set: 8 pts in C2, 8 in C3. Centrally confirmed CR by urine cytology and/or biopsy was 88% (95% CI 47-100) in C2 and 38% (9-76) in C3. Median CR duration of response for C2 and C3 was not reached after median follow-up of 13.6 and 12.0 wks, respectively. At data cutoff, 7 of 8 pts in C2 remained CR, with 3 ongoing responses ≥6 mo (range 7.7-9.4 mo). 11 pts (85%) in C2 and 8 (62%) in C3 had tx-emergent adverse events (TEAEs); most were Gr 1-2. The most common TEAEs were pollakiuria (39%), micturition urgency (39%), and noninfective cystitis (39%) in C2; fatigue (23%) and lipase increased (23%) in C3. 1 pt (8%) in C2 and 2 pts (15%) in C3 had tx-related Gr ≥3 TEAEs. 1 serious TEAE (myocarditis) occurred in C3. CONCLUSIONS: First results from SunRISe-1 show promising CR rate and safety profile with TAR-200 monotherapy, and CET results are consistent with other anti-PD(L)1 tx in this setting. Preliminary efficacy and safety data support the continued study in NMIBC. Source of Funding: Janssen Research & Development © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1187 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Siamak Daneshmand More articles by this author Michiel S van der Heijden More articles by this author Joseph M Jacob More articles by this author Andrea Necchi More articles by this author Evanguelos Xylinas More articles by this author David S Morris More articles by this author Philip Spiegelhalder 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 Shu Jin More articles by this author Christopher J Cutie More articles by this author Hussein Sweiti More articles by this author Katherine Stromberg More articles by this author Jason Martin More articles by this author Giuseppe Simone More articles by this author Expand All Advertisement PDF downloadLoading ...