Johnson & Johnson (JNJ) announced new data from an open-label, multicenter Phase 1 study evaluating Erda-iDRS, an investigational intravesical drug-releasing system with erdafitinib, in patients with non-muscle-invasive bladder cancer (NMIBC) harboring select FGFR alterations. Results were presented at the European Association of Urology (EAU) 2026 Annual Meeting.
FGFR alterations occur in approximately 70% of intermediate-risk and 40% of high-risk NMIBC tumors, making them an important therapeutic target. Erda-iDRS is designed to deliver prolonged release of erdafitinib directly into the bladder over three months, aiming to provide localized treatment while minimizing systemic exposure.
In the intermediate-risk cohort, Erda-iDRS achieved an 89% complete response rate, with a median duration of response of 18 months. Nearly half of patients remain in follow-up, underscoring the durability of benefit. In the high-risk cohort, median recurrence-free survival reached 20 months, with ongoing follow-up in 31% of patients.Treatment was generally well tolerated, with most adverse events limited to local effects such as hematuria (32%) and dysuria (22%). Grade 3 or higher events occurred in 5% of patients, and discontinuations due to adverse events were infrequent.
Pharmacokinetic analyses confirmed sustained drug levels in urine with minimal systemic exposure.
These findings support continued development of Erda-iDRS, with Phase 2 and Phase 3 studies underway to further evaluate its potential as the first targeted treatment for early-stage bladder cancer.
Johnson & Johnson closed Friday regular trading at $241.52, down $0.52 or 0.21%.
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