Results show potential of J&J’s TAR-210 to transform treatment of bladder cancer with FGFR alterations

Phase 1 trial shows 90 per cent recurrence-free survival and 90 per cent complete response in patients with high-risk and intermediate-risk non-muscle-invasive bladder cancer, respectively

 Janssen-Cilag International NV, a Johnson & Johnson company, recently updated results from an open-label, multicentre, multi-cohort Phase 1 study of the safety and efficacy of TAR-210, an intravesical targeted releasing system designed to provide sustained, local release of erdafitinib into the bladder, in patients with non-muscle-invasive bladder cancer (NMIBC) with select FGFR alterations. These data were featured in an Oral Presentation Session (Abstract #PD48-02)1 at the 2024 American Urological Association (AUA) Annual Meeting taking place 3-6 May, 2024, in San Antonio, Texas.

Results featured updated data from Cohort 1 (C1); patients with recurrent, Bacillus Calmette-Guérin (BCG)-unresponsive high-risk (HR) NMIBC (high-grade Ta/T1; papillary only) who refused or were ineligible for radical cystectomy and Cohort 3 (C3); patients with recurrent, intermediate-risk (IR) NMIBC (Ta/T1) low-grade papillary disease left in situ as tumour marker lesions. First results were featured at the European Society for Medical Oncology 2023 Congress, with interim results presented at the European Association of Urology (EAU) 2024 Annual Congress.2,3

At the data cutoff of March 22, 2024, 64 patients had been treated with TAR-210 across the two cohorts. Of the 21 patients in C1 with HR-NMIBC, the 12-month recurrence free (RF) survival rate was 90 per cent (95 per cent confidence interval (CI), 66-97). In C3, 31 patients were efficacy evaluable with 28/31 achieving a complete response (CR) rate of 90 per cent (95 per cent CI, 74-98).1

The most common treatment-related emergent adverse events (TEAEs) were Grade 1/2 lower urinary tract events. There were no dose-limiting toxicities and no deaths. Two patients (3 per cent) discontinued the study due to TEAEs of low-grade urinary symptoms and two patients had serious TEAEs with pyelonephritis and sepsis or UTI (urinary tract infection) and sepsis, respectively.