AUA 2024: Novel Therapies Demonstrate Promising Efficacy and Safety in Bladder Cancer  

Neal Shore, MD, FACS, discuss the key efficacy outcomes reported for nadofaragene firadenovec (ADSTILADRIN) in the phase 3 trial for patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) and compare these long-term results to other bladder-preserving therapies in this population.

1) A medical urologist discusses the rationale and design of the SunRISe-1 phase 2 trial, which evaluates the combination of intravesical TAR-200 and systemic cetrelimab, as well as the TAR-200 and cetrelimab monotherapy arms, in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR NMIBC), focusing on key efficacy and safety endpoints.

Neal Shore, MD, FACS, describes the patient population and treatment regimen evaluated in the NURE-COMBO phase 2 trial of neoadjuvant nivolumab plus nab-paclitaxel followed by adjuvant nivolumab in muscle-invasive bladder cancer (MIBC), and discusses the key efficacy results of pathologic complete response and major pathologic response rates.

A urologist discusses the prospective advantages of the novel gene therapy nadofaragene firadenovec compared to standard-of-care therapies for patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) and highlights the significance of the reported 5-year bladder preservation and overall survival rates.

Neal Shore, MD, FACS, discusses how the SunRISe-1 trial design addresses the need for bladder-sparing treatment options for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR NMIBC) who are ineligible for or refuse radical cystectomy. He also contrasts the treatment approach and outcomes observed in the NURE-COMBO trial with the current standard neoadjuvant chemotherapy plus radical cystectomy regimen for muscle-invasive bladder cancer (MIBC), discussing how this chemoimmunotherapy combination may potentially expand treatment options for this patient population.

Neal Shore, MD, FACS, discusses the safety profiles reported across the nadofaragene firadenovec, SunRISe-1, and NURE-COMBO trials, highlighting any unexpected toxicities observed with these novel therapies for non-muscle-invasive and muscle-invasive bladder cancer. Additionally, he reviews key limitations of the study designs or patient populations that may impact the interpretation and generalizability of the results from these trials.

Neal Shore, MD, FACS, shares his final thoughts on the current landscape of clinical trials for both non-muscle-invasive bladder cancer and muscle-invasive bladder cancer, providing insights into the potential impact and future directions of these studies.