The investigational erdafitinib (Balversa) intravesical drug-releasing system (Erda-iDRS; TAR-210) demonstrated preliminary efficacy and tolerability in patients with non–muscle-invasive bladder cancer (NMIBC) harboring select FGFR alterations, according to findings from a phase 1 study (NCT05316155) presented during the 41st Annual EAU Congress.1,2
Final Analysis of the Phase 1 First-in-Human Study of Erda-iDRS
- Erda-iDRS, an investigational erdafitinib intravesical drug-releasing system, demonstrated preliminary efficacy and tolerability in patients with FGFR-altered NMIBC.
- Patients with high-risk disease experienced a median RFS of 20 months (95% CI, 15-30). Those with intermediate-risk disease achieved a median CR duration of 18 months (95% CI, 14-25).
- In the overall population, TRAEs leading to treatment discontinuation and interruption occurred at respective rates of 9.1% and 4.5%, and there were no TRAEs that led to death.
At a median follow-up of 24 months (range, 15-30), findings from the final analysis of the first-in-human study revealed that patients who were treated with Erda-iDRS in cohort 1 (n = 26) experienced a median recurrence-free survival (RFS) of 20 months (95% CI, 15-30). The 12-month RFS rate in cohort 1 was 83% (95% CI, 62%-93%).1 In cohort 3 (n = 55), the 6-month complete response (CR) rate was 89% (95% CI, 78%-95%). The median follow-up duration in responders was 18 months (range, 15-21) and the median CR duration was also 18 months (95% CI, 14-25).
“Erda-iDRS achieved proof-of-concept for sustained local delivery of erdafitinib and demonstrated preliminary clinical activity in patients with FGFR-altered NMIBC,” Antoni Vilaseca, MD, PhD, MSc, an adjunct physician of the Urology Service at Hospital Clínic de Barcelona in Spain, said during the presentation.
How was the phase 1 study designed?
The open-label, multicenter study enrolled patients with FGFR-altered intermediate- and high-risk NMIBC.1,3 Cohort 1 enrolled patients with high-risk, recurrent, high-grade Ta/T1 papillary-only disease with no carcinoma in situ; patients in this cohort were also required to have received BCG, not undergone radical cystectomy, and undergo transurethral resection of bladder tumor prior to treatment with Erda-iDRS. Cohort 3 enrolled patients with intermediate-risk, recurrent disease with a history of low-grade only Ta/T1 disease and visible target lesions prior to treatment.
During the dose-escalation portion of the study (part 1), patients received Erda-iDRS at an approximate dose of 2 mg per day up to 4 mg per day; Erda-iDRS placement occurred every 3 months. In the dose-expansion portion (parts 2 and 3), patients received Erda-iDRS at an approximate dose of 2, 3, or 4 mg per day.
The primary end point was safety. Secondary end points included RFS in cohort 1, CR rate and duration in cohort 3, and pharmacokinetic measures.
At baseline, the median ages in cohorts 1 and 3 were 72.5 years (range, 37.0-90.0) and 68.5 years (range, 41.0-89.0), respectively. Most patients in both cohorts were male (73.1% vs 77.4%), White (80.8% vs 61.3%), had stage Ta disease (80.8% vs 96.8%), and had an ECOG performance status of 0 (65.4% vs 83.9%). Every patient in both cohorts underwent surgery or another procedure prior to enrollment. Other prior anticancer therapies included intravesical BCG (100% vs 22.6%), intravesical chemotherapy (23.1% vs 53.2%), and systemic therapy (3.8% vs 0%).
What were the safety data that were shared during the EAU Congress?
In terms of safety, patients in the overall population (n = 88) experienced any-grade treatment-related adverse effects (TRAEs) at a rate of 67.0%. The most common any-grade TRAEs that were reported in at least 10% of patients consisted of hematuria (31.8%), dysuria (21.6%), pollakiuria (14.8%), micturition urgency (14.8%), urinary tract infection (13.6%), and bladder spasm (10.2%). TRAEs leading to treatment discontinuation (9.1%) and interruption (4.5%) were reported, and there were no TRAEs that led to death.
Grade 3 or higher TRAEs occurred at a rate of 4.5%. Serious TRAEs consisted of pyelonephritis (n = 1), sepsis (n = 1), and hematuria (n = 1). No hyperphosphatemia or retinal toxicities were observed.
“[Erdafitinib] was tolerable, with mostly grade 1 or 2 lower urinary tract symptoms,” Vilaseca said. “Phase 2 and 3 trials of Erda-iDRS are ongoing in patients with FGFR-altered NMIBC in the MoonRISe program.”
Disclosures: Vilaseca received honoraria from Astellas Pharma, Johnson & Johnson/Janssen, Recordati, and Bayer; consulting/advisory fees from Johnson & Johnson/Janssen, Astellas Pharma, Recordati, and Accord Healthcare; and travel expenses from Ipsen and Recordati.
References
- Vilaseca A, Li R, Meeks J, et al. Final analysis of the phase 1 first-in-human study of erda-iDRS, an erdafitinib intravesical drug-releasing system, in patients with non–muscle-invasive bladder cancer harboring select FGFR alterations. Presented at: 41st Annual EAU Congress; March 13-16, 2026; London, United Kingdom. Abstract LB008.
- Johnson & Johnson highlights promising first-in-human erda-iDRS (formerly TAR-210) results in intermediate‑risk non–muscle-invasive bladder cancer. News release. Johnson & Johnson. March 13, 2026. Accessed March 27, 2026. https://www.jnj.com/media-center/press-releases/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. Updated March 13, 2026. Accessed March 27, 2026. https://clinicaltrials.gov/study/NCT05316155?term=NCT05316155&viewType=Card&rank=1
