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Efficacy: Japan Phase 3 Trial

Efficacy and Safety of ADSTILADRIN From
an Ongoing Phase 3 Trial in Japan

Interim 3-month results add to the growing body of evidence for the efficacy and safety of ADSTILADRIN

The efficacy and safety of ADSTILADRIN is currently undergoing
evaluation in NCT05704244, a phase 3, multicenter, single-arm, open-label study in Japan. This interim analysis reported complete response (CR)
rates and adverse events (AEs) at 3 months for 25 patients with Bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer, 20 of whom have carcinoma in situ (CIS) ± high-grade Ta/T1 (n=20/25).

Patients received a single 75-mL intravesical instillation once every 3 months in the absence of high-grade disease (no
reinduction permitted). The primary endpoint was CR at any time in the CIS ± high-grade Ta/T1 cohort. Secondary endpoints include durability of response, incidence of and time to cystectomy, overall survival (OS), and safety.

EFFICACY

3 months (primary endpoint)

75%
of participants
achieved CR (n=15)
Early findings at 3 months indicate there was no disease progression at the time of recurrence.

The efficacy of ADSTILADRIN is consistent with that observed in recent real-world data from the Mayo Clinic (CR rate, 79% [n=19/24])1,2

SAFETY

75%

of study drug–related AEs
WERE MILD (GRADE 1)1

NO

TREATMENT
DISCONTINUATIONS
due to study drug–related AEs1

NO

GRADE 3, 4, OR 5
study drug–related AEs1

NO

NEW SAFETY
SIGNALS OBSERVED1

The most frequently-reported AEs include pyrexia, fluid leakage around the urinary catheter during instillation, and micturition urgency.3

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References: 1. Jakobsen J. Efficacy and safety of nadofaragene firadenovec for BCG-unresponsive non-muscular-invasive bladder cancer: initial results from an ongoing Japanese phase 3 trial. Presented at: 112th Annual Meeting of the Japanese Urological Association. April 17-19; Fukuoka, Japan. 2. 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. 3. ADSTILADRIN. Package insert. Ferring Pharmaceuticals, Inc; october 2025.

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 Clinical Data

NEW CLINICAL
DATA

Discover new data from an ongoing phase 3 trial that supports the efficacy and safety of ADSTILADRIN.
See the data.