erdafitinib intravesical delivery system (TAR-210) / J&J - LARVOL DELTA

MOONRISE-1: PHASE 3 STUDY OF TAR-210, AN ERDAFITINIB INTRAVESICAL TARGETED RELEASING SYSTEM, VERSUS INTRAVESICAL CHEMOTHERAPY IN PATIENTS WITH FGFR-ALTERED INTERMEDIATE-RISK NON–MUSCLE-INVASIVE BLADDER CANCER (SUO 2024) - P3 | "MoonRISe-1 (NCT06319820) is an open-label, multicenter, phase 3, randomized study evaluating the efficacy and safety of TAR-210 versus investigator's choice of intravesical mitomycin C or gemcitabine in patients with FGFR -altered IR NMIBC. As of August 1, 2024, 9 patients have been randomized, and recruitment is ongoing at ≈70 sites. "

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology • FGFR

First-in-human study of TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer with select FGFR alterations (EMUC 2024) - P1 | "Data for durability continue to mature. A recommended phase 2 dose has been selected and a phase 3 study in intermediate-risk NMIBC is planned."

Clinical • P1 data • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Septic Shock • Solid Tumor • FGFR

Urine-based testing for patient selection and genomic characterization of patients with FGFR alteration-positive non–muscle-invasive bladder cancer (NMIBC) treated with TAR-210. (ASCO-GU 2024) - P1 | "Implementing a urine-based assay expands the molecular testing methods to identify additional patients that may respond to erdafitinib. Results justify further study. Clinical trial information: NCT05316155."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR • FGFR3

MoonRISe-3: a phase 3 study of erda-iDRS, an erdafitinib intravesical drug-releasing system, vs intravesical chemotherapy in patients with bacillus Calmette-Guérin–treated high-risk non–muscle-invasive bladder cancer with susceptible FGFR alterations (AUA 2026) - P3 | "Approximately 220 patients will be randomized 1:1 to receive erda-iDRS or investigator's choice of either IVES mitomycin C (MMC) or gemcitabine. The first patient was enrolled in Nov 2025. As of Jan 21, 2026, ∼120 patients have been screened, and recruitment is ongoing at ∼100 sites worldwide."

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

PHASE 3 STUDY OF TAR-210 INTRAVESICAL ERDAFITINI RELEASING SYSTEM VS INTRAVESICAL CHEMOTHERAPY IN PATIENTS WITH BACILLUS CALMETTE-GUÉRIN–TREATED HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER WITH SUSCEPTIBLE FGFR ALTERATIONS (AUA 2025) - "Approximately 220 pts will be randomized 1:1 to receive TAR-210 or investigator's choice of either IVES mitomycin C (MMC) or gemcitabine. Assessments will be based on urine cytology, bladder biopsy, and imaging. Enrollment is expected to open in 2025."

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

MOONRISE-1: PHASE 3 STUDY OF TAR-210, AN INTRAVESICAL ERDAFITINIB RELEASING SYSTEM, VERSUS INTRAVESICAL CHEMOTHERAPY IN PATIENTS WITH FGFR-ALTERED INTERMEDIATE-RISK NON–MUSCLE-INVASIVE BLADDER CANCER (AUA 2025) - P3 | "MoonRISe-1 (NCT06319820) is an open-label, multicenter, ph 3, randomized study evaluating efficacy and safety of TAR-210 vs investigator's choice of IVES mitomycin C (MMC) or gemcitabine (gem) in pts with FGFR-altered IR NMIBC. Pts (≥18 y) with histologically confirmed Ta low-grade (LG)/G1 (recurrent or primary with either multifocal/tumor ≥3 cm) or Ta LG/G2 (primary/recurrent) IR NMIBC diagnosed ≤90 d of randomization will be enrolled. Key secondary end points: time to next-line treatment, high-grade recurrence-free survival, progression-free survival, and rate of diagnostic and therapeutic invasive urologic interventions. As of Jan 30, 2025, 200 pts have been randomized, and recruitment is ongoing at ≈185 sites."

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology • FGFR • FGFR2

Erdafitinib in BCG-treated high-risk non-muscle invasive bladder cancer. (PubMed, Ann Oncol) - P2 | "Erdafitinib prolonged RFS compared with intravesical chemotherapy in patients with papillary-only, high-risk NMIBC harboring FGFR alterations who had disease recurrence after BCG therapy and refused or were ineligible for radical cystectomy. (Funded by Janssen Research & Development; ClinicalTrials.gov number, NCT04172675)."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR3

MoonRISe-2, a Phase 2 Dose Expansion Within the Study of Erdafitinib Intravesical Drug Releasing System (TAR-210) for Localized Bladder Cancer: Study Design and Baseline Characteristics (AUA 2026) - P1/2 | "Funding: Johnson & Johnson.an = 53.bOther intravesical therapies included cabergoline, cretostimogene grenadenorepvec, and pirarubicin in 1 patient (1.9%) each.cn = 47.dn = 16.en = 7. Median sum of lesion size was 15 mm; 73.6% of patients had multiple (≥2) tumors. Majority of patients had multiple prior cancer-related procedures, including median of 2 TURBTs; 42.6% had prior IVES therapy, including BCG (18.5%), mitomycin C (13.0%), gemcitabine (11.1%), and epirubicin (3.7%) (Table)."

P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

First safety and efficacy results of the TAR-210 erdafitinib (erda) intravesical delivery system in patients (pts) with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations (alt) (ESMO 2023) - P1, P2 | "Conclusions TAR-210 appears safe and well tolerated with predominantly low-grade urinary system AEs and high CR rate and RF survival in pts with NMIBC with FGFRalt. Results justify further study of targeted tx of erda using a novel intravesical delivery system in early-stage bladder cancer."

Clinical • Late-breaking abstract • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

Phase 3 study of TAR-210 intravesical erdafitinib releasing system vs intravesical chemotherapy in patients with Bacillus Calmette-Guérin–treated high-risk non–muscle-invasive bladder cancer with susceptible FGFR alterations (DGU 2025) - "220 pts will be randomized 1:1 to receive TAR-210 or investigator's choice of either IVES mitomycin C (MMC) or gemcitabine. Secondary end points include RFS, time to next intervention, time to disease worsening, time to progression, and overall survival. Assessments will be based on urine cytology, bladder biopsy, and imaging."

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

First safety and efficacy results of the TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer with select FGFR alterations (AUA 2024) - P1 | "TAR-210 appears safe and well tolerated with predominantly low-grade urinary system TRAEs and high CR rate and RF survival in patients with NMIBC with FGFRalt . Results justify further study of targeted treatment of erdafitinib using a novel intravesical delivery system in early-stage bladder cancer."

Clinical • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Septic Shock • Solid Tumor • FGFR

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (clinicaltrials.gov) - P1/2 | N=235 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

MoonRISe-1: A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (clinicaltrials.gov) - P3 | N=641 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2028 ➔ Dec 2032

Trial completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

MoonRISe-3: A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=220 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

MoonRISe-1: A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (clinicaltrials.gov) - P3 | N=540 | Recruiting | Sponsor: Janssen Research & Development, LLC | Initiation date: Apr 2024 ➔ Jan 2024

Trial initiation date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

MoonRISe-3: A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=220 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Aug 2027 ➔ Apr 2028

Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

MoonRISe-1: A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (clinicaltrials.gov) - P3 | N=540 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

MoonRISe-3: A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=220 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

MoonRISe-1: A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (clinicaltrials.gov) - P3 | N=540 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Emerging Intravesical Therapies for Non-Muscle-Invasive Bladder Cancer. (PubMed, Urol Clin North Am) - "Recent advances include UGN-102 for low-grade/intermediate-risk disease and multiple FDA-approved agents-nadofaragene firadenovec, TAR-200, and nogapendekin alfa inbakicept-for BCG-unresponsive disease. Ongoing trials of TAR-210, cretostimogene, and other combination regimens promise to further expand options. Comparative studies and real-world evidence will be critical to define optimal sequencing, benchmark outcomes against radical cystectomy, and address quality-of-life considerations."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

42756493BLC3004: A study comparing TAR-210 versus single agent treatment instilled directly into the bladder in people with bladder cancer with FGFR gene alterations. (clinicaltrialsregister.eu) - P2/3 | N=201 | Recruiting | Sponsor: Janssen Cilag International | Active, not recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

pH-responsive acetylated PAMAM dendrimer nanocarriers for enhanced intravesical delivery of Erdafitinib in urothelial carcinoma. (PubMed, Sci Rep) - No abstract available

Journal • Oncology • Solid Tumor • Urothelial Cancer

Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate‑risk non–muscle-invasive bladder cancer (J&J Press Release) - "The study met its primary safety endpoint and demonstrated complete and durable responses in patients with recurrent intermediate-risk disease, along with encouraging recurrence-free outcomes in high-risk disease...Data were presented during a late-breaking oral session at the European Association of Urology (EAU) 2026 Annual Meeting (Abstract #LB26-0083)...The complete response rate was 89 percent (95 percent confidence interval [CI], 78-95), based on tumor assessments during the initial treatment period...In the high-risk cohort, patients treated with Erda-iDRS had a median recurrence-free survival of 20 months (95 percent CI, 15-30), with a 12-month recurrence-free survival rate of 83 percent (95 percent CI, 62-93)."

First-in-human • Late-breaking abstract • P1 data • Bladder Cancer

MODULE 3: Current and Future Role of Novel Intravesical Therapies for Nonmetastatic Urothelial Bladder Cancer (UBC) (ASCO-GU 2026) - "This event is organized and accredited by Research To Practice and supported by educational grants from Genentech, a member of the Roche Group, Johnson & Johnson, and Natera Inc. Advantages of intravesical delivery systems in administering systemic therapies to patients with nonmetastatic UBC Available findings from the Phase IIb SunRISe-1 study evaluating the gemcitabine intravesical system and cetrelimab, the gemcitabine intravesical system alone or cetrelimab alone for patients with BCG-unresponsive high-risk NMIBC who are ineligible for or decline radical cystectomy Recent FDA approval of the gemcitabine intravesical system for the treatment of BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors; selection of appropriate candidates for this strategy Ongoing Phase III studies of the gemcitabine intravesical system with and without cetrelimab for NMIBC, such as SunRISe-3 and SunRISe-5 Initial safety and efficacy results with the TAR-210..."

Metastases • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

CR109248: A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer (clinicaltrials.gov) - P1 | N=5 | Active, not recruiting | Sponsor: Janssen Pharmaceutical K.K. | Trial completion date: Sep 2027 ➔ Aug 2026 | Trial primary completion date: Oct 2026 ➔ Mar 2025

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR