J&J reports 89% response rate in bladder cancer drug trial

Johnson & Johnson (NYSE: JNJ) announced results from a Phase 1 study of its investigational bladder cancer treatment Erda-iDRS, showing an 89% complete response rate in patients with intermediate-risk non-muscle-invasive bladder cancer.

The open-label, multicenter study evaluated the intravesical drug-releasing system containing erdafitinib in patients whose tumors harbor specific fibroblast growth factor receptor alterations. Results were presented at the European Association of Urology 2026 Annual Meeting.

The study included 62 patients with recurrent intermediate-risk disease and 26 patients with recurrent, high-risk non-muscle-invasive bladder cancer who had previously received Bacillus Calmette-Guérin therapy. The primary endpoint was safety, with secondary endpoints assessing complete response rates and duration.

In the intermediate-risk cohort, the median duration of complete response was 18 months, with 49% of patients remaining in follow-up. The high-risk cohort showed a median recurrence-free survival of 20 months, with an 83% recurrence-free survival rate at 12 months.

The treatment was generally well tolerated, with no dose-limiting toxicities observed. The most frequent treatment-related adverse events were hematuria (32%) and dysuria (22%). Eight patients discontinued treatment due to adverse events.

Erda-iDRS is designed to deliver prolonged, localized erdafitinib directly to the bladder over three months via intravesical administration. The system aims to minimize systemic exposure compared to oral administration of the kinase inhibitor.

Johnson & Johnson is conducting Phase 2 and Phase 3 studies through its MoonRISe program to further evaluate Erda-iDRS across intermediate- and high-risk settings. The company licensed erdafitinib from Astex Pharmaceuticals in 2008.

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