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Efficacy: REAL-WORLD evidence

Real-World Outcomes of ADSTILADRIN in ​
BCG-Unresponsive NMIBC

Methods

Patients with BCG-unresponsive NMIBC treated with ADSTILADRIN were retrospectively analyzed at 3 Mayo Clinic sites from November 2023 to December 2024. Outcomes included complete response (CR) rate, duration of response (DOR), high-grade recurrence-free survival (HGRFS), cystectomy-free survival (CFS), overall survival (OS), and adverse events (AEs). ​

AEs were reported as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0). Of note, failure to retain ADSTILADRIN was defined as any medication loss, including leakage around the catheter or voiding prior to the target 1-hour dwell time.​

Purpose

To evaluate outcomes in a multisite single-institution cohort

Dosing

Received a single 75-mL dose of ADSTILADRIN administered intravesically every 3 months

Disclosures

  • This is scientific information from a poster presented at the ASCO-GU 2025 annual meeting​
  • These are retrospective real-world evidence data based on a non-controlled and observational study design
  • These data were not funded or supported by Ferring Pharmaceuticals

Real-world results

  • 46 patients were treated with ADSTILADRIN during the study period, of whom 3 had scheduled, pending post-treatment cystoscopies. Thus, 43 patients were evaluable
  • Of evaluable patients with CIS ± papillary disease (n=24), the 3-month CR rate was 79% (n=19/24)
  • Median DOR was not reached; at a median follow-up of 7.3 months, 84% of responders (n=16/19) still had CRs

Data represents the true proportion of patients with a CR at 3 months.

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Data are displayed as Kaplan-Meier estimates.

  • At a median follow-up of 8.2 months, CFS and OS were 95% and 100%, respectively
  • 3 patients experienced progression: 1 from Ta to T1, 1 from CIS to T2, and 1 patient from Ta to metastatic disease
  • The most common AEs were grades 1-2 bladder spasms (61%) and failure to retain the instillation for the full hour (33%)
  • Additional AEs included micturition urgency, fatigue, dysuria, fevers, hematuria, dizziness, and other nonspecific AEs
  • 4 patients (9%) experienced grade 3 events
  • There were no grade 4 or 5 events. No patients discontinued therapy due to AEs

Patient-level HGRFS

CIS-containing cohort

Ongoing response

Reinduction

High-grade NMIBC recurrence

Progression to muscle-invasive bladder cancer

Radical cystectomy

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From the authors: future direction for research​

  • Early real-world data support the efficacy and safety of ADSTILADRIN in BCG-unresponsive NMIBC
  • Larger multicenter studies with extended follow-up will be valuable for additional validation

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References: 1. ADSTILADRIN. Package insert. Ferring Pharmaceuticals, Inc; August 2024. 2. Moyer J, Durand A, Nguyen M, et al. Real-world outcomes of nadofaragene firadenovec in BCG-unresponsive non-muscle invasive bladder cancer. J Clin Oncol. 2025;43(suppl 5):abstr 716. doi.org/10.1200/JCO.2025.43.5_suppl.716

Important Safety Information

INDICATION

ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.

WARNINGS AND PRECAUTIONS:

  • Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.
  • Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals.

DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration.

USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.

ADVERSE REACTIONS: The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination).

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-10881-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING1-888-FERRING.

Please see full Prescribing Information for ADSTILADRIN.

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New Real-World Evidence

New REAL-WORLD EVIDENCE

Discover new real-world evidence on patients treated with ADSTILADRIN that supports its efficacy and safety profile.See the data.