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European Association of Urology (EAU) 2026 Annual Meeting | News | Updates | iPharmaCenter

  • Badari Andukuri
  • 5 hours ago
  • 2 min read

Johnson & Johnson Reports Encouraging Early Results for Erda‑iDRS in Intermediate‑Risk Non-Muscle Invasive Bladder Cancer

Johnson & Johnson unveiled promising data from a Phase 1, open-label, multicenter clinical trial investigating its novel intravesical drug-release system containing erdafitinib (known as Erda‑iDRS, formerly TAR‑210) in patients with intermediate‑ and high‑risk non–muscle‑invasive bladder cancer (NMIBC) whose tumors carry specific FGFR (fibroblast growth factor receptor) mutations.

 


The therapy achieved its primary safety objective and showed a strong complete response rate with durable outcomes among patients with recurring intermediate‑risk NMIBC, along with favorable recurrence‑free results in those with high‑risk disease. Based on these findings, Johnson & Johnson is advancing the program into ongoing Phase 2 and Phase 3 trials to further validate the drug’s targeted potential across various disease categories.

 


Understanding the FGFR Target

FGFR gene alterations occur in a considerable proportion of early bladder cancers, around 70% of intermediate‑risk and 40% of high‑risk NMIBC cases. These mutations can drive tumor progression, making FGFR a valuable therapeutic focus.

 

Erda‑iDRS enables continuous, localized delivery of erdafitinib, a kinase inhibitor that is otherwise administered orally, directly into the bladder. This three‑month intravesical treatment aims to sustain drug exposure at the tumor site while limiting systemic absorption, potentially reducing side effects compared to oral dosing.

 


Study Highlights of Phase 1 results of Erda‑iDRS

The Phase 1 investigation enrolled patients with FGFR‑altered NMIBC, identified through urine or tissue analysis. Safety served as the primary outcome, while secondary measures evaluated complete response (CR) rates, CR duration for intermediate‑risk patients, and recurrence‑free survival (RFS) in high‑risk participants.

 

Intermediate‑risk group

Patients received Erda‑iDRS as a non‑surgical alternative for treating visible bladder tumors. The therapy achieved a complete response rate of 89%. For those who responded, the median CR duration was 18 months, based on a median follow‑up of 18 months . About 49% of these patients are still under follow‑up.

 

High‑risk group:

Participants experienced a median recurrence‑free survival of 20 months, with an 83% RFS rate at 12 months. After a median follow‑up of 24 months (range: 15–30), 31% of patients continue to be monitored.

 


Ongoing and Future Studies

Development of Erda‑iDRS continues through the MoonRISe clinical program, which includes:

  • MoonRISe‑1 (Phase 3) - NCT06319820: evaluating adjuvant therapy after tumor resection in intermediate‑risk patients.

  • MoonRISe‑2 (Phase 2) - NCT05316155: assessing ablative therapy for visible intermediate‑risk tumors without surgery.

  • MoonRISe‑3 (Phase 3) - NCT06919965: testing treatment in high‑risk papillary NMIBC patients previously treated with BCG, including those with BCG‑unresponsive disease.

 

About Erda‑iDRS

Erda‑iDRS is an experimental intravesical drug delivery platform created to provide sustained, localized release of erdafitinib directly within the bladder. This investigational system is currently being evaluated in Phase 1 trials for patients with non–muscle‑invasive bladder cancer, including both high‑risk and intermediate‑risk populations (some with visible tumors or BCG‑resistant disease).

Additional Phase 2 and Phase 3 trials are underway to explore its performance more broadly across these risk categories.

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