AUA 2019: Nadofaragene firadenovec (Adstiladrin®) — Late-Breaking Phase 2 Data for Patients with High-grade, BCG Refractory or Relapsed Non-muscle Invasive Bladder Cancer

Chicago, IL ( In a podium presentation as part of the Society of Urologic Oncology program at the American Urologic Association Annual Meeting, Dr. Colin Dinney presented the late-breaking phase 2 data regarding Nadofaragene firadenovec (Adstiladrin®) (rAd-interferon-alpha/Syn3; nadofaragene firadenovec) in BCG unresponsive non-muscle invasive bladder cancer (NMIBC). The twelve-month data from this trial was previously reported and published in the Journal of Clinical Oncology. At twelve months, 35% of patients were free of high-grade recurrence.

In this presentation, Dr. Dinney presented updated results from this cohort with three year data. He sought to address four key questions:

  1. Was patient outcome and safety jeopardized by salvage treatment withNadofaragene firadenovec (Adstiladrin®)?
  2. Was survival of patients who failed to respond toNadofaragene firadenovec (Adstiladrin®) threatened?
  3. What was the longer term outcome for patients who achieved a complete response at 12 months?
  4. In patients who achieved a complete response at 12 months, were these patients able to avoid radical cystectomy?
Of the forty patients initially accrued to this phase II study, 6 (15%) were lost to follow-up. Thus, this report focused on the remaining 34 patients. Of these 34 men, 24 were alive at 36 months. Of the 10 men who died during follow-up, 3 died of bladder cancer while 7 died of other causes.

Of the 26 patients who were initial non-responders, 2 were lost to follow-up. 18 of the remained 24 patients were alive at three years. Two patients progressed and died of bladder cancer while 4 died of other cause. Thus, Dr. Dinney concluded that progression and death from bladder cancer was uncommon for patients who failed to initially respond toNadofaragene firadenovec (Adstiladrin®).

Of the 18 non-responders who were alive at 3 years, 13 had undergone radical cystectomy in the intervening time. While pathology data was only available for 7 of these 13 patients, there was no evidence of muscle invasion in these patients and all demonstrated no evidence of disease at 3 years.

Among the 14 patients who achieved an initial complete response, 4 were lost to follow-up. Of the remaining 10, 6 were alive with no evidence of disease at 3 years with one having required chemoradiotherapy. Two patients died of upper tract urothelial carcinoma and two died of unknown causes. No patient who achieved an initial complete response at 12 months underwent subsequent radical cystectomy by three years but one patient underwent chemoradiotherapy due to progression to clinical T2 disease.

He concluded by highlighting the importance of ongoing phase III trials ofNadofaragene firadenovec (Adstiladrin®) prior to the adoption of this approach in patients with BCG unresponsive NMIBC.

Clinical Trial Information: NCT01687244

Presented by: Colin Dinney, MD, Department Head, MD Anderson Cancer Center

Written by: Christopher J.D. Wallis, Urology Resident, University of Toronto, @WallisCJD on Twitter at the American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois
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