Johnson & Johnson (J&J) has reported encouraging results from a Phase I study of the investigational intravesical drug-releasing system, Erda-iDRS (erdafitinib).
The trial targets patients with intermediate-risk and high-risk non–muscle-invasive bladder cancer (NMIBC) harbouring select fibroblast growth factor receptor (FGFR) alterations.
The multi-centre, open-label trial met its primary safety endpoint, showed durable, complete responses in intermediate-risk patients, and encouraging recurrence-free outcomes in high-risk disease.
Data were presented at the European Association of Urology 2026 Annual Meeting.
Erda-iDRS delivers erdafitinib directly into the bladder via intravesical administration over three months, enabling localised therapy to minimise systemic exposure and adverse events associated with oral administration.
As of 3 November 2025, 62 recurrent intermediate-risk NMIBC patients and 26 recurrent, Bacillus Calmette-Guérin-experienced high-risk NMIBC patients received Erda-iDRS.
Safety was the primary endpoint, while secondary endpoints assessed complete response rate and duration for intermediate-risk cases and recurrence-free survival for high-risk cases.
In intermediate-risk patients receiving non-surgical treatment for visible tumours, the complete response rate was 89% within the initial treatment period. The median complete response duration was 18 months, with a median follow-up of 18 months. 49% of these patients are still being monitored.
Among high-risk patients treated with Erda-iDRS, median recurrence-free survival was 20 months, and the 12-month recurrence-free survival rate was 83%. Median follow-up in this group was 24 months, with 31% remaining under observation.
Treatment was found to be generally well tolerated, and no dose-limiting toxicities were reported. Local adverse events were most common, including haematuria and dysuria.
Four patients experienced grade three or higher adverse events related to treatment; eight patients discontinued due to adverse events; and two patients had serious treatment-related adverse events.
Pharmacokinetic data showed sustained urinary drug levels and minimal systemic exposure without observed hyperphosphataemia.
J&J bladder cancer disease area leader Christopher Cutie said: “For patients with FGFR-altered non–muscle-invasive bladder cancer, care has historically not been guided by precision-based approaches.
“The high and durable complete responses demonstrated with Erda-iDRS highlight the opportunity to deliver a targeted therapy to these patients. Bringing a biology-based approach into earlier stages of this disease has the potential to change how these patients are treated.”
Last month, J&J reported new findings from the QUASAR long-term extension study of Tremfya (guselkumab) for ulcerative colitis (UC).
