Johnson & Johnson's Erda-iDRS Shows 89% Complete Response Rate in First-in-Human Bladder Cancer Study
核心洞察
Johnson & Johnson's investigational Erda-iDRS (搜索) achieved an 89% complete response rate in intermediate-risk non-muscle-invasive bladder cancer patients with FGFR (搜索) alterations in a Phase 1 study.
The intravesical drug delivery system demonstrated durable responses with a median duration of 18 months and showed encouraging recurrence-free survival outcomes in high-risk patients.
The treatment was generally well tolerated with predominantly local adverse events, supporting advancement to ongoing Phase 2 and Phase 3 trials in the MoonRISe program.
Johnson & Johnson announced promising first-in-human results for its investigational erdafitinib intravesical drug-releasing system (Erda-iDRS (搜索)) in patients with non-muscle-invasive bladder cancer harboring fibroblast growth factor receptor (搜索) (FGFR (搜索)) alterations. The Phase 1 study demonstrated an 89% complete response rate in intermediate-risk disease with durable responses observed over 18 months, positioning Erda-iDRS as a potential first targeted treatment for early-stage bladder cancer.
The data, presented at the European Association of Urology (EAU) 2026 Annual Meeting, showed that the study met its primary safety endpoint while demonstrating complete and durable responses in patients with recurrent intermediate-risk disease, along with encouraging recurrence-free outcomes in high-risk disease.
Targeting FGFR Alterations in Bladder Cancer
FGFR (搜索) alterations are common in early-stage bladder cancer, occurring in approximately 70% of intermediate-risk and 40% of high-risk non-muscle-invasive bladder cancer tumors. These genetic changes may drive tumor growth, representing an important therapeutic target in this setting.
Erda-iDRS (搜索) is designed to provide prolonged release of erdafitinib, an oral kinase inhibitor, directly into the bladder via intravesical administration over a three-month period. This approach aims to enable localized treatment while minimizing systemic exposure and the risk of adverse events associated with oral administration.
"Intermediate-risk non-muscle-invasive bladder cancer is defined by recurrences, and many patients undergo repeated procedures as their tumors return," said Antoni Vilaseca Cabo, M.D., adjunct physician of the Urology Service at Hospital Clínic de Barcelona in Spain, and presenting author. "In this study, treatment with Erda-iDRS (搜索) led most patients with FGFR (搜索)-altered disease to achieve a complete response by the end of the second treatment cycle, and many of those responses were sustained over time."
Study Design and Patient Population
The open-label, multicenter Phase 1 study evaluated Erda-iDRS (搜索) in patients with non-muscle-invasive bladder cancer harboring select FGFR (搜索) alterations identified by urine and/or tissue testing. As of November 3, 2025, 62 patients with recurrent intermediate-risk non-muscle-invasive bladder cancer and 26 patients with recurrent, Bacillus Calmette-Guérin (BCG)-experienced, high-risk non-muscle-invasive bladder cancer had received treatment.
The primary endpoint was safety, with secondary endpoints assessing complete response rate and duration of complete response in the intermediate-risk cohort and recurrence-free survival in the high-risk cohort.
Efficacy Results Across Risk Groups
Intermediate-Risk Cohort
In the intermediate-risk cohort, Erda-iDRS (搜索) was evaluated as a non-surgical treatment for visible tumors. The complete response rate was 89% (95% confidence interval [CI], 78-95), based on tumor assessments during the initial treatment period. Among responders, the median duration of complete response was 18 months (95% CI, 14-25), with a median follow-up of 18 months (range, 15-21), indicating prolonged responses over time. Forty-nine percent of patients remain in follow-up.
High-Risk Cohort
In the high-risk cohort, patients treated with Erda-iDRS (搜索) had a median recurrence-free survival of 20 months (95% CI, 15-30), with a 12-month recurrence-free survival rate of 83% (95% CI, 62-93). With a median recurrence-free survival follow-up of 24 months (range, 15-30), 31% of patients remain in follow-up.
Safety Profile
Treatment was generally well tolerated, as evidenced by the absence of dose-limiting toxicities and a safety profile characterized by predominantly local adverse events. In the combined cohorts, the most frequent treatment-related adverse events (TRAEs) were hematuria (32%) and dysuria (22%). Grade 3 or higher TRAEs occurred in four patients (5%). Eight patients (9%) discontinued treatment due to adverse events, and two patients (2%) experienced serious TRAEs.
Pharmacokinetic analyses demonstrated prolonged drug levels in the urine, with limited systemic exposure and no observed hyperphosphatemia.
Advancing Precision Medicine in Bladder Cancer
"For patients with FGFR (搜索)-altered non-muscle-invasive bladder cancer, care has historically not been guided by precision-based approaches," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson. "The high and durable complete responses demonstrated with Erda-iDRS (搜索) highlight the opportunity to deliver a targeted therapy to these patients. Bringing a biology-based approach into earlier stages of this disease has the potential to change how these patients are treated."
MoonRISe Development Program
Phase 2 and Phase 3 studies are ongoing to evaluate Erda-iDRS (搜索) in intermediate- and high-risk non-muscle-invasive bladder cancer. The MoonRISe program includes the Phase 3 MoonRISe-1 study (NCT06319820) in intermediate-risk disease in the adjuvant setting (after tumor resection), the Phase 2 MoonRISe-2 study (NCT05316155) in intermediate-risk disease in the ablative setting (evaluating treatment of visible tumors without surgery), and the Phase 3 MoonRISe-3 study (NCT06919965) in patients with high-risk papillary non-muscle-invasive bladder cancer who received prior BCG therapy, including those with BCG-unresponsive disease, in the adjuvant setting.
Clinical Context
Non-muscle-invasive bladder cancer (NMIBC) is an early stage of bladder cancer confined to the lining of the bladder, accounting for approximately 75% of newly diagnosed bladder cancer cases. NMIBC is categorized as low-, intermediate-, or high-risk based on tumor characteristics and likelihood of recurrence or progression.
Patients with intermediate-risk NMIBC experience frequent tumor recurrences that often require repeated procedures and ongoing monitoring. High-risk NMIBC carries a greater likelihood of progression to muscle-invasive disease, which may require radical cystectomy. Despite available treatments, recurrence and progression remain common across intermediate- and high-risk disease, underscoring the need for durable bladder treatment options.