- Phase 1 study of Erda-iDRS met safety endpoint with 89% complete response in intermediate-risk bladder cancer.
- Erda-iDRS provides localized erdafitinib release over three months, minimizing systemic exposure.
- Ongoing Phase 2 and 3 studies are evaluating Erda-iDRS in intermediate- and high-risk bladder cancer.
- FGFR alterations occur in 70% of intermediate-risk and 40% of high-risk bladder cancer tumors.
Study Overview
Johnson & Johnson announced results from a Phase 1 study of Erda-iDRS, an investigational intravesical drug-releasing system with erdafitinib, targeting intermediate- and high-risk non–muscle-invasive bladder cancer (NMIBC) with FGFR alterations. The study met its primary safety endpoint and showed promising efficacy.
Key Findings
In the intermediate-risk cohort, Erda-iDRS achieved an 89% complete response rate, with a median response duration of 18 months. In the high-risk cohort, the median recurrence-free survival was 20 months, with an 83% 12-month recurrence-free survival rate.
Mechanism and Administration
Erda-iDRS is designed for prolonged erdafitinib release directly into the bladder over three months, aiming to reduce systemic exposure and adverse events. FGFR alterations, present in 70% of intermediate-risk and 40% of high-risk NMIBC tumors, are targeted by this approach.
Safety Profile
Treatment was generally well tolerated, with no dose-limiting toxicities. The most common treatment-related adverse events were hematuria (32%) and dysuria (22%). Serious adverse events were rare, occurring in 2% of patients.
Future Development
Phase 2 and Phase 3 studies are ongoing to further evaluate Erda-iDRS in different risk settings of NMIBC. These studies aim to confirm the efficacy and safety of this targeted therapy approach.
