Johnson & Johnson reports Phase 1 results for Erda-iDRS, an intravesical erdafitinib drug-releasing system demonstrating durable responses in FGFR-altered non–muscle-invasive bladder cancer
Written By: Sana Khan Pharm
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson reported positive results from a Phase 1 open-label (NCT05316155), multicentre study evaluating an investigational erdafitinib intravesical drug-releasing system (Erda-iDRS) in patients with intermediate- and high-risk non–muscle-invasive bladder cancer (NMIBC) harboring fibroblast growth factor receptor (FGFR) alterations.
The study met its primary safety endpoint and demonstrated high and durable responses, supporting continued development of the therapy. The findings were presented during a late-breaking session at the European Association of Urology (EAU) 2026 Annual Meeting.
FGFR alterations are common in early bladder cancer, occurring in about 70% of intermediate-risk and 40% of high-risk NMIBC tumors, where they can drive tumor growth.
Erda-iDRS is designed to deliver erdafitinib directly into the bladder through an intravesical drug-releasing system that provides continuous drug exposure for up to three months, enabling localized treatment while limiting systemic exposure typically associated with oral FGFR inhibitors.
As of November 3, 2025, the study included 62 patients with recurrent intermediate-risk NMIBC and 26 patients with recurrent BCG-experienced high-risk NMIBC with confirmed FGFR alterations.
In the intermediate-risk cohort, where the therapy was evaluated as a non-surgical treatment for visible tumors, Erda-iDRS achieved a complete response rate of 89% (95% CI, 78–95). Responses were durable, with a median duration of complete response of 18 months and a median follow-up of 18 months; 49% of patients remain in follow-up.
In the high-risk cohort, treatment produced encouraging disease control, with a median recurrence-free survival of 20 months (95% CI, 15–30) and a 12-month recurrence-free survival rate of 83% (95% CI, 62–93). Median follow-up for recurrence-free survival was 24 months, and 31% of patients remain in follow-up.
The therapy was generally well tolerated with no dose-limiting toxicities. The most common treatment-related adverse events were hematuria (32%) and dysuria (22%), reflecting mainly local bladder effects. Grade 3 or higher treatment-related adverse events occurred in 5% of patients, while 9% discontinued treatment due to adverse events and two patients experienced serious treatment-related events.
Pharmacokinetic analysis showed sustained drug levels in urine with limited systemic exposure, and no cases of hyperphosphatemia were observed.
Erda-iDRS is being further evaluated through the MoonRISe clinical program, which includes the Phase 3 MoonRISe-1 trial (NCT06319820) studying adjuvant therapy in intermediate-risk NMIBC after tumor resection, the Phase 2 MoonRISe-2 trial (NCT05316155) assessing treatment of visible tumors without surgery in intermediate-risk disease, and the Phase 3 MoonRISe-3 trial (NCT06919965) evaluating adjuvant therapy in high-risk papillary NMIBC following prior BCG treatment.
Non–muscle-invasive bladder cancer accounts for about 75% of newly diagnosed bladder cancer cases and remains confined to the bladder lining. Patients with intermediate-risk disease often experience repeated tumor recurrences requiring ongoing procedures, while high-risk NMIBC carries a greater risk of progression to muscle-invasive disease that may require radical cystectomy. Durable bladder-preserving treatment options remain an important unmet need in this setting.
References
Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate‑risk non–muscle-invasive bladder cancer, 13 March 2026, Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate‑risk non–muscle-invasive bladder cancer
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer, ClinicalTrials.gov ID NCT05316155, https://clinicaltrials.gov/study/NCT05316155
About the Writer
Sana Jamil Khan is a B.Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.