Photocure Partner Asieris Presented Clinical Trial and Real-World Data on Hexvix in China at ASCO GU 2024

Reno, Nevada (UroToday.com) -- Photocure ASA (OSE: PHO), The Bladder Cancer Company, announces that its partner Asieris presented Phase III Clinical Study and Real-World Research Data for Hexvix® (APL-1706) at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU), on Friday, January 26, 2024 in San Francisco.

The poster presentation (Abstract No. 593) “Blue Light Cystoscopy versus White Light Cystoscopy for the Detection of Bladder Cancer in China: An Analysis of Unpublished Clinical Trial and Real-World Data.” included data from a recent randomized controlled trial (RCT) as well as heretofore unpublished data from the Hexvix real-world evidence study (RWS) in China.

The study included 158 patients enrolled in an RCT, of which 114 underwent Blue Light Cystoscopy (BLC®) with Hexvix. 19 patients were included in the real-world study (RWS). Among patients diagnosed with Ta, T1, or CIS, 42 out of 97 patients (43.3%) in the RCT and 4 out of 12 patients (33.3%) in the RWS had at least one lesion detected with BLC but not with white light cystoscopy (WLC) (p<0.0001).

Both the RCT and RWS confirmed that Blue Light Cystoscopy with Hexvix demonstrated superior detection of bladder cancer in the Chinese population compared to WLC, especially in the CIS population, with good tolerability.

Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. In January 2021, Asieris entered into a license agreement with Photocure ASA to obtain the exclusive registration and commercialization rights of Hexvix in mainland China and Taiwan. The new drug application (NDA) was accepted by the National Medical Products Administration (NMPA) in November 2023.

Source: Photocure ASA. (2024). Photocure Partner Asieris Presented Clinical Trial and Real-World Data on Hexvix in China at ASCO GU 2024 [Press release]. https://photocure.com/news/photocure-partner-asieris-presented-clinical-trial-and-real-world-data-on-hexvix-in-china-at-asco-gu-2024-4734694.

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ASCO GU 2024: Blue Light Cystoscopy Versus White Light Cystoscopy for the Detection of Bladder Cancer in China: An Analysis of Unpublished Clinical Trial and Real-World Data