First Results with Erdafitinib-Releasing Intravesical Delivery System (TAR-210) Show Early Evidence of Positive Clinical Activity in Patients with Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the first results from an open-label, multicenter Phase 1 study evaluating the safety and efficacy of TAR-210, an intravesical delivery system designed to provide sustained, local release of erdafitinib into the bladder in patients with non-muscle-invasive bladder cancer (NMIBC) with select fibroblast growth factor receptor (FGFR) alterations. These data were featured today in a Late-Breaking Mini-Oral Presentation Session (Abstract #LBA104) at the European Society for Medical Oncology (ESMO) 2023 Congress taking place October 20-24 in Madrid, Spain.¹

Results featured 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 intermediate-risk (IR) NMIBC (Ta/T1) low-grade papillary disease] left in situ as tumor marker lesions.

At the data cutoff of 29 August 2023, 43 patients had been treated with TAR-210 across the two cohorts. Of the 16 patients in C1 with HR NMIBC having at least one response assessment, 82 percent were recurrence-free (RF). Median duration of treatment exposure was 3.7 months, with 94 percent of the 16 patients still on study. In C3, 87 percent of the 27 patients having at least one response assessment with IR NMIBC achieved a complete response (CR). Median duration of treatment exposure was 4.2 months.

The most common treatment-related adverse events (TRAEs) were Grade 1/2 lower urinary tract TRAEs. There were no dose-limiting toxicities and no deaths. Two patients discontinued the study due to TRAEs of low-grade urinary symptoms and one patient had serious TRAEs of pyelonephritis and sepsis.

“Patients with high- or intermediate-risk non-muscle-invasive bladder cancer have seen limited advancement in the treatment landscape over the last 50 years and the available options are associated with a high risk of recurrence and significant side effect burden,” said Antoni Vilaseca,^* M.D., Ph.D. of the Hospital Clínic de Barcelona and presenting author of the Phase 1 TAR-210 study. “We look forward to further results from this study in the future and the ongoing development of the localized delivery of erdafitinib.”

“We are advancing this novel technology with the ambition of bringing bladder-sparing and BCG-free regimens to patients with localized bladder cancer,” said Jeffrey Infante, M.D., Global Head, Oncology Early Clinical Development and Translational Research, Janssen Research & Development, LLC. “These encouraging results reinforce our commitment to improving patient outcomes by treating early-stage disease with this intravesical delivery technology.”