Johnson & Johnson presented new late-breaking First-in-Human (FIH) Phase 1 data for Erda-iDRS (TAR-210), an investigational intravesical drug-releasing system, designed to provide sustained, local release of erdafitinib into the bladder, in patients with fibroblast growth factor receptor (FGFR) altered non-muscle-invasive bladder cancer (NMIBC).

This Erda-iDRS data provides early clinical validation of an investigational, targeted, localised bladder preserving therapy, addressing an unmet need in a population where recurrence rates remain high despite available treatment options.

What is the Data?

• Early clinical activity: Erda-iDRS demonstrated a complete response rate by the 6-month disease evaluation of 89 percent (95% confidence interval [CI], 78–95) in patients with recurrent intermediate risk NMIBC (Ta/T1) with a history of low-grade disease, with a median duration of complete response of 18 months (95% CI, 14–25).
• Durability and disease control: In recurrent BCG-experienced high-risk NMIBC (high-grade Ta/T1, papillary only) and not undergoing radical cystectomy, median recurrence-free survival was 20 months (95% CI, 15–30), with a 12-month recurrence-free survival of 83 percent (95% CI, 62–93).
• Favourable safety and delivery profile: No unexpected safety signals were observed, with 5% Grade 3 or higher treatment-related adverse events, and no observed hyperphosphatemia.¹ Data confirm preliminary efficacy of Erda-iDRS and sustained local delivery of erdafitinib.

Why does this Matter?

·       NMIBC accounts for approximately 75% of newly diagnosed bladder cancers. Recurrence remains common despite intravesical therapies, with a proportion of patients progressing to radical cystectomy (removal of the bladder and neighboring structures and organs).

·       Radical cystectomy is associated with significant morbidity and quality of life impact, underscoring the need for effective bladder-preserving strategies.

·       FGFR alterations are among the most common molecular alterations in NMIBC, particularly in low-grade and intermediate-risk disease, and can also be present in high-risk tumours.

Erda-iDRS is being further evaluated in controlled clinical studies tailored to defined disease settings, enabling clearer insights on efficacy and patient experience than surveillance-based approaches.