Intravesical drug delivery system exhibits bladder cancer benefit

A novel intravesical targeted drug delivery system for patients with bladder cancer has demonstrated positive data in updated results from a Phase I trial. Johnson & Johnson’s Phase I study is assessing the safety and efficacy of TAR-210 as a delivery method for sustained, local release of erdafitinib into the bladder. The treatment is being evaluated in patients with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations.

The new findings were taken from:

• Cohort 1: 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
• Cohort 3 patients with recurrent, intermediate-risk NMIBC (Ta/T1) low-grade papillary disease left in situ as tumour marker lesions.

At the data cutoff (22 March 2024), the results showed:

• The 12-month recurrence-free survival rate was 90 percent in 21 HR-NMIBC patients (Cohort 1)
• A complete response rate of 90 percent was observed in 31 efficacy evaluable patients (Cohort 3).

Johnson & Johnson highlighted that the US Food and Drug Administration (FDA) approved oral erdafitinib as BALVERSA^® (erdafitinib) for locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, in individuals who have progressed on or after at least one line of prior systemic therapy.

TAR-210: a promising alternative treatment option

“Advancement in the treatment landscape of high- or intermediate-risk non–muscle-invasive bladder cancer has remained stagnant for more than 50 years,” stated Dr Antoni Vilaseca, PhD, of the Hospital Clínic de Barcelona, presenting author of the Phase I TAR-210 study. “Results presented today further underscore that TAR-210 for the localised treatment of bladder cancer may offer a promising alternative for patients with limited treatment options.”

The findings “further support the potential of TAR-210 with quarterly administration as a bladder-sparing and BCG-free treatment option,” commented Dr Sabine Brookman-May, Vice President, Late Development Oncology, Johnson & Johnson Innovative Medicine.

These data for the drug delivery system for erdafitinib were featured at the 2024 American Urological Association (AUA) Annual Meeting.

Moreover, initial study findings were featured at the European Society for Medical Oncology 2023 Congress. Interim results were presented at the European Association of Urology (EAU) 2024 Annual Congress.