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
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.
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Source of Funding:
Janssen Research & Development
