Johnson & Johnson’s Bladder Cancer Therapy Delivers 89% Response and 18-Month Durability
Johnson & Johnson’s Erda-iDRS achieved an 89 percent complete response rate in intermediate-risk non–muscle-invasive bladder cancer with a median 18-month duration of response and no dose-limiting toxicities. The Phase 1 study also showed a 20-month median recurrence-free survival in high-risk patients, supporting further Phase 2 and 3 trials.
1. Phase 1 Study Design
Erda-iDRS was evaluated in an open-label, multicenter Phase 1 study enrolling 62 patients with intermediate-risk and 26 patients with high-risk non–muscle-invasive bladder cancer carrying FGFR alterations. The primary endpoint was safety, with secondary endpoints including complete response rate in intermediate-risk disease and recurrence-free survival in high-risk disease.
2. Efficacy Outcomes
In the intermediate-risk cohort, 89 percent of patients achieved complete response, with a median response durability of 18 months and 49 percent of patients still in follow-up. The high-risk cohort demonstrated a median recurrence-free survival of 20 months and an 83 percent 12-month recurrence-free rate.
3. Safety Profile
Treatment was generally well tolerated, with no dose-limiting toxicities observed. The most common treatment-related adverse events were hematuria (32%) and dysuria (22%), while grade 3 or higher events occurred in 5 percent of patients and led to discontinuation in 9 percent.
4. Ongoing Development
Based on these results, Johnson & Johnson is advancing Erda-iDRS into Phase 2 and Phase 3 studies under the MoonRISe program, including MoonRISe-1 and -3 in adjuvant settings for intermediate- and high-risk patients and MoonRISe-2 for ablative treatment of visible tumors without surgery.