Efficacy: REAL-WORLD evidence

Real-World Outcomes
of ADSTILADRIN in

BCG-Unresponsive NMIBC¹

Methods

Patients with Bacillus
Calmette-Guérin (BCG)-unresponsive
non–muscle-invasive bladder cancer (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

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

Disclosures

This is scientific information from a poster presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium
These are retrospective real-world evidence data based on a noncontrolled and observational study design
These data were not funded or supported by Ferring Pharmaceuticals

Real-world outcomes in BCG-unresponsive NMIBC

46 patients were treated with ADSTILADRIN during the study period,
of whom 3 had scheduled cystoscopies pending post-treatment. Thus,
43 patients were evaluable
Of evaluable patients with carcinoma in situ (CIS) ± papillary disease (n=24), the 3-month CR rate was 79% (n=19/24)
- 5 recurrences of NMIBC at 3 months in the CIS cohort, with recurrence of CIS only in 3 patients and CIS with Ta in 2 patients

CR at 3 months

At a median follow-up of 9.3 months, 68% of responders (n=13/19) still had CRs.

Median DOR was not reached

Safety

The most common AEs were grade 1–2 bladder spasms (61%) and failure to retain the instillation for the full hour (33%), micturition urgency (20%), fatigue (17%), and dysuria (13%)
4 patients (9%) experienced grade 3 events

There were no grade 4 or 5 AEs.
No patients discontinued therapy due to AEs

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References: 1. Moyer JA, Durant A, Nguyen M, et al. Real-world outcomes of nadofaragene firadenovec in BCG-unresponsive non-muscle invasive bladder cancer. Poster presented at: 2025 ASCO Genitourinary Cancers Symposium. February 13-15, 2025; San Francisco, CA.

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.

Efficacy: REAL-WORLD evidence

Real-World Outcomes of ADSTILADRIN in BCG-Unresponsive NMIBC1

Methods

Purpose

Dosing

Disclosures

Real-world outcomes in BCG-unresponsive NMIBC

CR at 3 months

Safety

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IMPORTANT SAFETY INFORMATION

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NEW CLINICAL DATA

Real-World Outcomes
of ADSTILADRIN in

BCG-Unresponsive NMIBC¹

NEW CLINICAL
DATA