Ferring decided to prioritize collection of ADSTILADRIN re-induction data in patients with HR BCG-unresponsive NMIBC who did not have a CR to the initial dose of ADSTILADRIN through data sources within the clinical setting including ABLE-22 and -41.

In this phase 4 trial (000439), subjects with NMIBC CIS (± high-grade Ta/T1) who have not responded to their first dose of nadofaragene firadenovec (commercial ADSTILADRIN received before trial entry) will be offered reinduction when entering the trial.

Inclusion Criteria:

• Diagnosed, as documented, with CIS ± high-grade disease Ta/T1 and absence of progression after first dose of nadofaragene firadenovec within the last 5 months from instillation.

• Diagnosed, as documented, with:

  • Low risk of disease progression as assessed at the discretion of the investigator
  • Previous Bacillus Calmette Guerin (BCG) therapy (BCG exposed) with no maximum limit to the amount of BCG administered

Exclusion Criteria:

• Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased risk of muscle-invasive include but are not limited to:

  • Presence of lymphovascular invasion and / or micropapillary disease as shown in the histology of the biopsy sample
  • Subjects with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor

• Current and prior systemic or local therapy for bladder cancer since first dose of nadofaragene firadenovec

• Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug (drug used in a clinical trial, i.e drug used in a Ferring sponsored non-interventional study does not apply) since first dose of nadofaragene firadenovec

• Clinically significant and unexplained elevated liver or renal function tests

• History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤pT2 upper tract urothelial carcinoma at least 24 months after nephroureterectomy. Also subjects with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance are excluded