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Nadofaragene Firadenovec Meets Complete Response Endpoint in High-Grade NMIBC

Gina Columbus @ginacolumbusonc
Published: Friday, Dec 06, 2019

Colin P.N. Dinney, MD, professor and chairman of the Department of Urology at The University of Texas MD Anderson Cancer Center

Colin P.N. Dinney, MD

The investigational gene therapy nadofaragene firadenovec (rAd-IFN/Syn3) demonstrated a 3-month complete response (CR) rate of 53% in patients with high-grade, Bacillus Calmette-Guérin (BCG)–unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without concomitant high-grade Ta or T1 papillary disease, meeting the primary endpoint of a phase III trial (NCT02773849).1

“As a practicing urologist and trial investigator, it’s encouraging to see these types of efficacy and safety results in patients with high-grade NMIBC, an area that’s been in need of new innovative treatment options for more than 20 years,” Neal Shore, MD, FACS, medical director, Carolina Urologic Research Center, stated in the press release. “These robust clinical results further demonstrate the potential of nadofaragene firadenovec as a valuable treatment option for NMIBC patients.”


  1. FerGene Announces Pivotal Phase 3 Study of Nadofaragene Firadenovec Met Its Primary Endpoint With More Than Half of Patients With High-Grade Non-Muscle Invasive Bladder Cancer (CIS ± Ta/T1) Achieving a Complete Response at Three Months. FerGene. Published December 5, 2019. Accessed December 6, 2019.
  2. Ferring and Blackstone Life Sciences invest over 0 million USD in novel gene therapy for bladder cancer patients. Ferring Pharmaceuticals. Published November 25, 2019. Accessed December 6, 2019.

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