An evaluation of nadofaragene firadenovec-vncg for the treatment of high-risk BCG-unresponsive non-muscle-invasive bladder cancer

ABSTRACT

Introduction

BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) represent a significant therapeutic challenge in the treatment of bladder cancer. Nadofaragene firadenovec, represents a breakthrough in this area, offering a novel approach for the treatment of BCG-unresponsive NMIBC.

Areas covered

This overview explores the historical development of nadofaragene firadenovec, assessing its efficacy and safety, and discusses future NMIBC therapy directions.

Expert opinion

Patients with high grade NMIBC who are BCG unresponsive will have a growing number of treatment alternatives to bladder removal. Nadofaragene firadenovec offers good short-term efficacy but lacks significant durability for most patients. Its strengths include ease of administration and low risk of adverse events. This will need to balance with risk of progression and cost. Furthermore, the likely approval of other agents will require consideration of which therapy to use and for which patient. The need for biomarkers to tailor treatment choices to individual patient needs is becoming more critical. The treatment field is rapidly advancing, with several Phase 3 single-arm trials underway, indicating a potential broader range of treatment options for NMIBC. Further research will be necessary to determine the optimal choice for patients.

KEYWORDS:

• Bacillus Calmette-Guerin
• non-muscle invasive bladder cancer
• carcinoma in situ
• gene therapy
• interferon-2b
• bladder sparing treatment

Abbreviation

NMIBC	=	Non-muscle invasive bladder cancer
HR-NMIBC	=	High-risk non-muscle invasive bladder cancer
CIS	=	Carcinoma in situ
FDA	=	Food and Drug Administration
CR	=	Complete response
BCG	=	Bacillus Calmette-Guérin
IFNα	=	Interferon alpha

Declaration of interest

Y Lotan has acted as a consultant for Nanorobotics, C2I genomics, Photocure, Astra-Zeneca, Merck, Fergene, Abbvie, Nucleix, Ambu, Seattle Genetics, Hitachi, Ferring Research, Verity Pharmaceutics, Virtuoso Surgical, Stimit, Urogen, Vessi Medical, CAPs Medical, Xcures, BMS, Nonagen, Aura Biosciences, Inc., Convergent Genomics, Pacific Edge, Pfizer, Phinomics Inc, CG Oncology, Uroviu, On Target Lab, Promis Diagnostics, Valar Labs and Uroessentials. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Company review

Ferring Pharmaceuticals provided a scientific accuracy review at the request of the journal editor.