Pd48-02 First Safety and Efficacy Results of the Tar-210 Erdafitinib Intravesical Delivery System in Patients With Non–muscle-Invasive Bladder Cancer With Select FGFR Alterations

You have accessJournal of UrologyBladder Cancer: Non-invasive III (PD48)1 May 2024PD48-02 FIRST SAFETY AND EFFICACY RESULTS OF THE TAR-210 ERDAFITINIB INTRAVESICAL DELIVERY SYSTEM IN PATIENTS WITH NON–MUSCLE-INVASIVE BLADDER CANCER WITH SELECT FGFR ALTERATIONS Antoni Vilaseca, Gautam Jayram, Carles Raventos, Neal D. Shore, Daniel Zainfeld, Taek Won Kang, Ja Hyeon Ku, Joshua Meeks, Oscar Rodriguez Faba, Florian Roghmann, Siamak Daneshmand, Neil Beeharry, Carrye R. Cost, Anna Kalota, Josh Lauring, Michelle R. Peterson, Michelle Quiroz, Nicole L. Stone, Wei Zhu, and Felix Gurrero Ramos Antoni VilasecaAntoni Vilaseca , Gautam JayramGautam Jayram , Carles RaventosCarles Raventos , Neal D. ShoreNeal D. Shore , Daniel ZainfeldDaniel Zainfeld , Taek Won KangTaek Won Kang , Ja Hyeon KuJa Hyeon Ku , Joshua MeeksJoshua Meeks , Oscar Rodriguez FabaOscar Rodriguez Faba , Florian RoghmannFlorian Roghmann , Siamak DaneshmandSiamak Daneshmand , Neil BeeharryNeil Beeharry , Carrye R. CostCarrye R. Cost , Anna KalotaAnna Kalota , Josh LauringJosh Lauring , Michelle R. PetersonMichelle R. Peterson , Michelle QuirozMichelle Quiroz , Nicole L. StoneNicole L. Stone , Wei ZhuWei Zhu , and Felix Gurrero RamosFelix Gurrero Ramos View All Author Informationhttps://doi.org/10.1097/01.JU.0001008712.53259.7d.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Treatment options are limited in non–muscle-invasive bladder cancer (NMIBC) that recurs after intravesical chemotherapy or Bacillus Calmette-Guérin (BCG). TAR-210 is a novel intravesical drug delivery system designed to provide local, continuous release of erdafitinib (selective pan-FGFR tyrosine kinase inhibitor) within the bladder while limiting systemic toxicities. This open-label, multicenter phase 1 study (NCT05316155) evaluated the safety, pharmacokinetics (PK), and efficacy of TAR-210 in patients with NMIBC whose tumors harbor select FGFRalt. METHODS: FGFRalt were identified in tumor tissue or urine cell-free DNA. Cohort 1 (C1) patients had recurrent, BCG-experienced high-risk NMIBC (high-grade Ta/T1; papillary only) and refused or were ineligible for radical cystectomy. Cohort 3 (C3) patients had recurrent, intermediate-risk NMIBC (Ta/T1) with history of only low-grade papillary disease. Before treatment, C1 patients must have all visible disease resected; C3 requires the presence of visible tumors. TAR-210 systems with two different erdafitinib release rates were evaluated. Response is assessed every 3 months with continued treatment for up to 1 year if recurrence-free (RF) (C1) or in complete response (CR) (C3). RESULTS: As of August 29, 2023, 16 patients in C1 and 27 patients in C3 have been treated; 11 and 15 patients, respectively, had ≥1 response assessment. 82% in C1 were RF; 87% in C3 achieved CR (Table 1). Most common treatment-related adverse events (TRAE) were grade 1/2 lower urinary tract TRAEs. There were no dose-limiting toxicities. No deaths were reported. Two patients discontinued due to TRAEs of low-grade urinary symptoms, and one patient had serious TRAEs of pyelonephritis and sepsis. PK data showed sustained erdafitinib concentrations in urine with very low plasma exposures. Initial results are reported; updated data (≈47 response evaluable patients) will be included in the presentation. CONCLUSIONS: TAR-210 appears safe and well tolerated with predominantly low-grade urinary system TRAEs and high CR rate and RF survival in patients with NMIBC with FGFRalt. Results justify further study of targeted treatment of erdafitinib using a novel intravesical delivery system in early-stage bladder cancer. Source of Funding: Janssen Research & Development © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e987 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Antoni Vilaseca More articles by this author Gautam Jayram More articles by this author Carles Raventos More articles by this author Neal D. Shore More articles by this author Daniel Zainfeld More articles by this author Taek Won Kang More articles by this author Ja Hyeon Ku More articles by this author Joshua Meeks More articles by this author Oscar Rodriguez Faba More articles by this author Florian Roghmann More articles by this author Siamak Daneshmand More articles by this author Neil Beeharry More articles by this author Carrye R. Cost More articles by this author Anna Kalota More articles by this author Josh Lauring More articles by this author Michelle R. Peterson More articles by this author Michelle Quiroz More articles by this author Nicole L. Stone More articles by this author Wei Zhu More articles by this author Felix Gurrero Ramos More articles by this author Expand All Advertisement PDF downloadLoading ...