SCS AUA 2025: Enrollment Characteristics of Underrepresented Patients in Clinical Trials Using Cretostimogene Grenadenorepvec for High Risk BCG-Unresponsive NMIBC

(UroToday.com) The 2025 South Central AUA annual meeting included a session on bladder cancer, featuring a presentation from Dr. Yair Lotan discussing enrollment characteristics of underrepresented patients in clinical trials using cretostimogene grenadenorepvec for high risk BCG-unresponsive non muscle invasive bladder cancer. Bladder cancer is a common malignancy in the United States, with an estimated 85,000 new cases in 2025. Despite this incidence, there are widespread disparities in treatment and outcome by race, ethnicity, and sex. For instance, non-Hispanic Black and Hispanic patients are commonly diagnosed at higher stage and have worse treatment outcomes compared to non-Hispanic Whites.¹ Similarly, women are diagnosed later and have higher cancer-specific mortality when compared to men.¹ The NIH Revitalization Act passed in 1993 to improve participation and reporting of minority populations in clinical trials, yet treatment disparities persist. Importantly, many bladder cancer trials note dramatically lower rates of enrollment of underrepresented populations.^2,3

A retrospective review of the screened patients from two high risk BCG-unresponsive non muscle invasive bladder cancer clinical trials with cretostimogene grenadenorepvec was performed. The racial, gender, and ethnic distribution in each study was assessed and compared to published historical data across 27 BCG unresponsive non muscle invasive bladder cancer trials (n = 1,673) from 1998-2021. These data were used to formulate a broad Diversity Plan, in keeping with guidance from the US FDA, with efforts to increase representation of diverse patients, providers, and sites.

In BOND-003, a phase 3 study of intravesical cretostimogene monotherapy in patients with high risk BCG-unresponsive non muscle invasive bladder cancer, 71 US participants were enrolled and treated. Of these, 87.3% were non-Hispanic Whites, 5.6% were Hispanic, 4.2% were non-Hispanic Black, and 2.8% were Asian Pacific Islanders. Additionally, 71.8% of study participants were male and 28.2% were female. In CORE-001, a phase 2 study of cretostimogene with pembrolizumab, 86.6% of participants were non-Hispanic Whites, 10.0% were non-Hispanic Black, and 3.4% were Hispanic. Of the patients screened in the United States, 97.7% were male, and 3.3% were female:

Dr. Lotan concluded his presentation discussing enrollment characteristics of underrepresented patients in clinical trials using cretostimogene grenadenorepvec for high risk BCG-unresponsive non muscle invasive bladder cancer with the following take home points:

The enrollment characteristics in the two cretostimogene studies in patients with high risk BCG-unresponsive non muscle invasive bladder cancer demonstrate a generalizable racial and ethnic distribution of bladder cancer patients and exceeds the racial and sex distribution reported in many bladder cancer clinical trials³
Recognizing the disparities in bladder cancer care, there is a pressing need to improve access for underrepresented patient populations
One significant effort to bridge this gap is the innovative expanded access program (CRETO-EAP), which provides compassionate use of cretostimogene for real world patients who may not be eligible for standard high risk BCG-unresponsive non muscle invasive bladder cancer with CIS clinical trials
This initiative underscores the critical importance of enabling access and promoting diversity in ongoing clinical trials for high risk BCG-unresponsive non muscle invasive bladder cancer, ultimately striving for more inclusive and equitable healthcare outcomes

Presented by: Yair Lotan, MD, UT Southwestern Medical Center, Dallas, TX

Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2025 South Central American Urological Association (AUA) Annual Meeting, Orlando, FL, Wed, Sept 10 – Sat, Sept 13, 2025.

References:

Login