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

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 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

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

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

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

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

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

In a first-in-human study, TAR-210 was well-tolerated, with encouraging clinical activity in FGFR-altered intermediate-risk non-muscle invasive bladder cancer. (UroToday) - "The 12-week complete response rate was 90%, with a 9-month duration of response of 89%."

First-in-human • P1/2 data • Bladder Cancer • Urothelial Cancer

Erdafitinib in Patients with High- and Intermediate-risk Non-muscle-invasive Bladder Cancer: Final Analysis of THOR-2 Study. (PubMed, Eur Urol) - "Oral erdafitinib demonstrated high efficacy in FGFR3/2alt HR-/IR-NMIBC, with a manageable safety profile."

Journal • Bladder Cancer • Genito-urinary Cancer • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor • FGFR3

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

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

Novel intravesical delivery systems for nonmuscle invasive bladder cancer. (PubMed, Curr Opin Urol) - "Novel intravesical delivery systems show to enhance drug retention, improve tissue penetration, and potentially reduce adverse events. While traditional chemotherapy or BCG remain the gold-standard adjuvant treatments for NMIBC, these novel approaches offer promising alternatives for selected patients pending on ongoing clinical validation."

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

Johnson & Johnson unveils highly anticipated and potential practice-changing data in bladder cancer treatment at AUA (PRNewswire) - "AUA 2025 Presentation Highlights: Trial-in-progress mini-oral presentation from the Phase 3 MoonRISe-1 study evaluating TAR-210, an erdafitinib intravesical drug-releasing system, versus intravesical chemotherapy in patients with fibroblast growth factor receptors (FGFR)-altered intermediate-risk NMIBC (Clinical Trials in Progress Presentation); Trial-in-progress presentation from the Phase 3 SunRISe-5 study evaluating TAR-200 compared to intravesical chemotherapy after treatment with BCG in patients with recurrent HR-NMIBC (Clinical Trials in Progress Presentation)."

Trial status • Bladder Cancer • Urothelial Cancer

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

Biological and therapeutic implications of FGFR alterations in urothelial cancer: A systematic review from non-muscle-invasive to metastatic disease. (PubMed, Actas Urol Esp (Engl Ed)) - "Two phase 3 trials are currently evaluating the intravesical device system (TAR210) in FGFR-altered intermediate NMIBC (MoonRISe-1) and infigratinib in the adjuvant setting of high-risk of recurrence patients with MIBC or UTUC (PROOF-302)...Nine phase 1b/2 trials are focusing on the combination of FGFR inhibitors with ICIs, chemotherapy, or enfortumab vedotin...However, no phase 3 trial is terminated, so there is currently no level 1 evidence with long-term outcomes to support the combination of FGFR inhibitors with ICIs, chemotherapy, or targeted therapies. A better understanding of the different mechanisms of action to inhibit FGFR signaling pathways, optimal patient selection and treatment approaches is still needed."

IO biomarker • Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR • FGFR2 • FGFR3

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (clinicaltrials.gov) - P1/2 | N=262 | Recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P1 ➔ P1/2

Phase classification • 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=540 | Recruiting | Sponsor: Janssen Research & Development, LLC | Initiation date: Apr 2024 ➔ Jan 2024

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

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. | Recruiting ➔ Active, not recruiting

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

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (clinicaltrials.gov) - P1 | N=262 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=112 ➔ 262 | Trial completion date: Jun 2029 ➔ Sep 2029

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

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2028 ➔ Jun 2029

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

FGFR-Altered NMIBC Treatment Advances With TAR-210 Findings (Targeted Oncology) - P1 | N=112 | NCT05316155 | Sponsor: Janssen Research & Development, LLC | "Findings showed that the estimated 12-month RFS rate at a median follow-up of 8.9 months was 90% among patients with high-risk NMIBC and FGFR alterations (cohort 1; n = 21). The median RFS was not estimable. Two patients had recurrence and no difference in RFS was seen between TAR-210 dose levels. In cohort 3, which included 31 response-evaluable patients with intermediate-risk NMIBC and FGFR alterations, the 12-week CR rate was 90%, with all patients achieving a clinical response. The CR rate remained consistent across all dose levels, and 86% of CRs were ongoing at the time of data cutoff. Durable response rates were 100% (95% CI, 100%-100%) at 6 months and 89% (95% CI, 43%-98%) at 9 months."

P1 data • Bladder Cancer

Urine-based molecular testing identifies FGFR alteration-positive patients for treatment with TAR-210 (ESMO 2024) - P1, P3 | "Urine testing identifies additional NMIBC pts who may respond to erdafitinib, which is especially valuable when the parallel tissue sample submitted does not return a result. Findings support urine testing for pt selection in the recently initiated phase 3 study (MoonRISe-1, NCT06319820)."

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

Drug Delivery Systems in Bladder Cancer: TAR200 and TAR-210 Clinical Trials and Future Opportunities (IBCN 2024) - "Sponsored by Johnson & Johnson"

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

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 (MA-AUA 2024) - No abstract available

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