Investigational Novel Strategies in High-Risk BCG-Unresponsive NMIBC


This episode explores the potential of emerging therapies in providing effective treatment alternatives for challenging NMIBC cases. Current clinical trials and investigational treatments for high-risk, BCG-unresponsive NMIBC are highlighted, including the use of N-803, an IL-15 superagonist, in combination with BCG, and discusses TAR-200, an intravesical drug delivery system, which releases gemcitabine directly into the bladder over time.

This is a synopsis of the Viewpoints video series featuring moderator, Sam S. Chang, MD, MBA, from Vanderbilt University School of Medicine, and panelists Gary Steinberg, MD, FACS, from Rush University Medical Center, Mark Tyson, MD, of Mayo Clinic Phoenix, Roger Li, MD, from Moffitt Cancer Center, and Sandip M. Prasad, MD, MPhil, of Morristown Medical Center.

Episode 7 delves into the evolving landscape of clinical trials and new treatments for high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). The panel, featuring esteemed urology experts, discusses 2 promising investigational agents: N-803 and TAR-200. N-803, an Interleukin-15 (IL-15) superagonist, is explored for its potential benefits when used in combination with BCG. Although not yet FDA-approved, N-803 has shown encouraging long-term results. The combination of N-803 with BCG represents a significant advancement in treating high-risk NMIBC, particularly in the context of BCG shortages. The panelists note that while the requirement for concurrent BCG administration might present challenges, the overall outcomes look promising. The conversation then shifts to TAR-200, which represents a novel approach to bladder cancer treatment as a device about the size of a quarter that is inserted into the bladder and it has a unique mechanism of slowly releasing gemcitabine over an extended period. The panelists also discuss the promising results of the TAR-200 studies that indicate that TAR-200 could be an effective option for patients who are not suitable candidates for cystectomy or radiation therapy. The SUNRISE studies, which focus on safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive high-risk NMIBC CIS patients who are ineligible for, or decline, radical cystectomy.By allowing longer exposure to the chemotherapeutic agent, these studies aim to repurpose existing treatments for more challenging disease categories.

In summary, Episode 7 of the Urology Times® Viewpoints provides valuable insights into emerging therapies for high-risk, BCG-unresponsive NMIBC. The panel emphasizes the importance of both cytotoxic and immunotherapy-based approaches, underscoring the need for continued innovation in NMIBC treatment.

*Video synopsis is AI-generated and reviewed by Urology Times® editorial staff.

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