Bladder Cancer

Long-Term Benefits of Blue Light Cystoscopy and Enhanced Detection with HD Technology Unveiled at AUA 2024

OSLO, Norway, May 7, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces its participation in the congress, and two abstract presentations at the AUA 2024: the American Urological Association Annual Congress 2024 was held May 3-6, 2024, in San Antonio, TX, USA. The results of the BRAVO study performed within the VA healthcare system showed significant decreases in the risk of recurrence and progression, as well as the potential for improved overall survival in patients who received a blue light cystoscopy (BLC) compared to patients whose cystoscopy was only performed under white light. Another comparison of BLC with Hexvix/Cysview and white light cystoscopy (WLC), for the detection of bladder cancer using modern HD 4K equipment, was presented in an abstract from the multicenter phase III study of Hexvix in China, including new real world evidence data.

On Sunday, May 5^th, Dr. Sanjay Das presented the study, "Use of Blue Light Cystoscopy Among Non-Muscle Invasive Bladder Cancer Patients and Outcomes in an Equal Access setting: A Propensity Scored Matched Analysis."

The study, known as BRAVO (Bladder Cancer Recurrence Analysis in Veterans and Outcomes), is a retrospective, propensity score matched analysis that evaluated oncologic outcomes following BLC compared to WLC alone in patients from the Veterans Affairs Healthcare System. The study addresses a lack of practical real-world data comparing the impact of BLC versus WLC, specifically for recurrence, progression, and survival. The results of this study confirm that BLC use is associated with positive and statistically significant impacts on these outcomes. The Veterans' Affairs (VA) Healthcare system accepts all U.S. Veterans, regardless of financial background, and retains its patients, allowing for high-quality data capture over a long-term follow-up period, therefore serving as a robust real-world model for equal access.

626 patients were included in this study, 313 in each study arm (WLC versus BLC). Recurrence and progression data for BRAVO was measured at a 3-year time point. Overall survival follow-up was for 10 years.

Study results include:

• Risk of recurrence was significantly lower following BLC (HR 0.60, 95% CI 0.29-0.61) – 40% reduction in risk of recurrence. This confirms data from multiple RCT studies.
• Patients who underwent BLC had significantly reduced risk of progression (HR 0.51, 95% CI 0.36-0.99) compared to patients who underwent WLC.
• There was improved overall survival among BLC vs. WLC (HR 0.41, 95% CI 0.30-0.72)
• Additionally, in the equal-access setting of the VA Healthcare System, benefits of BLC were equitably shared between race/gender.

The Principal Investigator of the BRAVO Study, Dr. Steven Williams, commented: "The results of the BRAVO study performed within the VA healthcare system showed significant decreases in the risk of recurrence and progression, as well as the potential for improved overall survival in patients who received a BLC compared to patients who received WLC only. These findings demonstrate the benefit of BL-enhanced cystoscopy as part of comprehensive care for NMIBC* patients, especially as improved tumor visualization helps to appropriately make determination of intravesical therapy use, such as BCG. The results are encouraging and consistent with prior clinical trial long-term oncological outcomes. It supports the generalizability of prior clinical trial results in the real-world clinical practice setting. The demonstrated impact on overall survival warrants future studies to better understand the oncologic benefit of BLC in NMIBC."