Emerging Treatments High-Risk BCG-Unresponsive NMIBC setting

Opinion
Video

This video segment provides insights into various innovative trials and agents being explored for high-risk BCG-unresponsive NMIBC. The discussion covers a range of approaches including oncolytic immunotherapy, gene therapy, systemic IO agents, antibody-drug conjugates, and cytokine therapies. It emphasizes the need for personalized dosing regimens based on individual immune responses and highlights the significance of longer-term efficacy evaluations beyond initial three-month response rates.

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 9 sheds light on innovative treatments and clinical trials for high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). The panel of experts delves into a variety of approaches, including oncolytic immunotherapy, gene therapy, systemic immuno-oncology (IO) agents, antibody-drug conjugates (ADCs), and cytokine therapies. The discussion emphasizes the importance of personalized dosing regimens tailored to individual immune responses and underscores the significance of assessing longer-term efficacy beyond initial three-month response rates. Dr. Gary Steinberg highlights the multifaceted approach in treating NMIBC, mentioning oncolytic immunotherapy and gene therapy, including adstiladrin (nadofaragene firadenovec). He references trials involving single-agent systemic IO agents and ADCs, such intravesical enfortumab vedotin (EV), an antibody-drug conjugate (ADC). Another notable mention is cytokine therapy with N-803, an immune cell–activating interleukin-15 (IL-15) superagonist combined with BCG, and EG-70 DNA delivery system delivering both IL-12 and activators of the innate immune receptor RIG-I to stimulate the immune system directly intravesically. The discussion also touches on dosing regimens (eg, EG 70 schedule of 800 micrograms administered at specific intervals over a 12-week period). Experts agree on the need to understand and assess individual patient immune responses to develop more intelligent dosing strategies. They point out that the immune system's response can vary, suggesting that complete responses might be observed later than the standard three-month mark, possibly at six months or one year. The conversation also includes other exciting trials and investigational agents, highlighting an approach that potentially reduces the patient burden and aligns with the current trend towards more effective and less burdensome cancer treatments. The panelists draw parallels to the evolution of treatment in other cancers like prostate and kidney cancer, where the introduction of novel agents and adjuvant immunotherapies has significantly advanced care.

In summary, Episode 9 provides an extensive overview of emerging treatments in high-risk BCG-unresponsive NMIBC, highlighting the importance of personalized medicine, longer-term efficacy evaluations, and the potential of novel therapeutic agents and strategies in improving patient outcomes.

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

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