Johnson & Johnson disclosed that its first‑in‑human, open‑label, multicenter Phase 1 study of the investigational intravesical drug‑releasing system with erdafitinib (Erda‑iDRS) met its primary safety endpoint in patients with intermediate‑risk and high‑risk non‑muscle‑invasive bladder cancer (NMIBC). The study enrolled 88 patients with FGFR‑altered tumors, comprising 62 intermediate‑risk and 26 high‑risk participants.
In the intermediate‑risk cohort, 89 % of patients achieved a complete response, with a median duration of 18 months. The high‑risk cohort achieved an 83 % recurrence‑free survival rate at 12 months, and the median time to recurrence was 20 months. No dose‑limiting toxicities were observed.
The most common treatment‑related adverse events were hematuria (32 %) and dysuria (22 %). The safety profile aligns with the localized delivery of erdafitinib, limiting systemic exposure.
The data, with a cutoff of November 3 2025, were presented at the European Association of Urology 2026 Annual Meeting in London (March 13‑16). The results support the continuation of Erda‑iDRS into Phase 2 and Phase 3 studies under the MoonRISe program.
Erda‑iDRS represents a novel intravesical approach that delivers an FGFR inhibitor directly to the bladder, potentially filling an unmet need for non‑surgical options in intermediate‑ and high‑risk NMIBC. The program builds on Johnson & Johnson’s prior intravesical platform, including the FDA‑approved Inlexzo (TAR‑200) for BCG‑unresponsive NMIBC, and leverages the company’s 2019 acquisition of Taris Biomedical.
With FGFR alterations present in roughly 70 % of intermediate‑risk and 40 % of high‑risk NMIBC tumors, the study’s positive safety and efficacy signals could broaden the therapeutic landscape and strengthen Johnson & Johnson’s oncology portfolio.
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