The highly statistically significant results corroborate the findings of Photocure’s own randomized controlled trials (RCTs) that demonstrate the clinical benefits of Hexvix BLC over WLC, specifically superior tumor detection and a favorable tolerability profile with no serious adverse events. Moreover, Asieris’ Phase III Hexvix trial is the first RCT conducted with high definition 4K blue light capital equipment.
“This randomized-controlled trial reinforces the benefits of BLC with Hexvix in tumor detection over WLC alone with clinically convincing and statistically significant results. This is on the backdrop of this Chinese trial being the first RCT conducted with 4K high definition (HD) blue light equipment, making it a valuable addition to the body of evidence already available on BLC with Hexvix. It confirms that BLC with Hexvix is additive to WL also with high quality HD imaging technology. We are pleased to see and acknowledge that our partners at Asieris are driving innovation to support unmet needs in bladder cancer”, said Anders Neijber, Photocure’s Chief Medical Officer.The trial results have been selected as a “late-breaking abstract” at the 43rd Congress of the Société Internationale d’Urologie (SIU) in Istanbul, Turkey, October 11-14. The clinical study data will be presented today, October 12, in the form of an Oral ePoster at 1:45pm local time.
The study is a prospective, self-controlled, multicenter Phase Ⅲ study intended to evaluate the safety and detection benefits of blue light cystoscopy (BLC®) with Hexvix compared to white light cystoscopy (WLC) in the diagnosis of non-muscle invasive bladder cancer (NMIBC) in a Chinese population. The study included a total of 158 patients, of which 114 underwent BLC. Of the 97 patients diagnosed with NMIBC, a total of 42 patients (43.3%) had one or more additional lesions detected with Hexvix BLC compared to WLC (p<0.0001). Among the 114 patients, 11.4% (13/114) had CIS lesions, and among these, 11 patients (84.6%, 11/13) had additional CIS lesions detected under Hexvix BLC that were not found under WLC. The detection rates for PUNLMP, CIS, Ta, T1, and T2-T4 tumor lesions in the BLC group were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while in the WLC group, they were NA, 42.1%, 76.1%, 91.2%, and 100%, respectively.
Read Asieris’ full media release here:
Asieris Pharmaceuticals 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.
Source: Photocure October 12, 2023. ASA Positive Results for Hexvix Phase III Clinical Trial in China Presented at the SIU 2023 Congress. [Press Release] https://www.photocure.com/news/positive-results-for-hexvix-phase-iii-clinical-trial-in-china-presented-at-the-siu-2023-congress-4648309