Johnson & Johnson has reported Phase 1 data for Erda-iDRS (formerly TAR-210), an investigational intravesical drug-releasing system delivering erdafitinib for patients with non–muscle-invasive bladder cancer (NMIBC) whose tumors have select FGFR alterations. The open-label, multicenter study included patients with recurrent intermediate-risk and high-risk NMIBC and met its primary safety endpoint.
In the intermediate-risk cohort, 62 patients with recurrent disease received Erda-iDRS as a nonsurgical treatment for visible tumors. The complete response rate was 89 percent (95 percent CI, 78–95), with a median duration of response of 18 months (95 percent CI, 14–25) and median follow-up of 18 months; 49 percent of patients remain in follow-up. In the high-risk cohort of 26 Bacillus Calmette-Guérin (BCG)-experienced patients, median recurrence-free survival was 20 months (95 percent CI, 15–30), with a 12‑month recurrence-free survival rate of 83 percent (95 percent CI, 62–93) and 31 percent of patients still in follow-up at a median of 24 months.
Investigators reported that treatment was generally well tolerated, with no dose-limiting toxicities observed and mostly local adverse events. The most frequent treatment-related adverse events across cohorts were hematuria (32 percent) and dysuria (22 percent). Grade 3 or higher treatment-related adverse events occurred in 5 percent of patients; 9 percent discontinued treatment due to adverse events and 2 percent experienced serious treatment-related events. Pharmacokinetic analyses indicated prolonged urinary drug levels with limited systemic exposure and no observed hyperphosphatemia.
Erda-iDRS is designed to release erdafitinib locally into the bladder over approximately three months via intravesical administration, with the aim of targeting FGFR-altered tumors while limiting systemic exposure. FGFR alterations are reported in about 70 percent of intermediate-risk and 40 percent of high-risk NMIBC tumors, making them a relevant molecular target in this setting. The Phase 1 results were presented during a late-breaking oral session at the European Association of Urology (EAU) 2026 Annual Meeting.
Further evaluation of Erda-iDRS is underway in the MoonRISe clinical program. This includes the Phase 3 MoonRISe-1 trial (NCT06319820) in intermediate-risk NMIBC in the adjuvant setting after tumor resection, the Phase 2 MoonRISe-2 trial (NCT05316155) in intermediate-risk disease in the ablative setting without surgery, and the Phase 3 MoonRISe-3 trial (NCT06919965) in patients with high-risk papillary NMIBC previously treated with BCG, including BCG‑unresponsive disease, in the adjuvant setting.
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