On October 12, 2023 Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, reported that it has unveiled its phase III clinical trial data for APL-1706 (Hexvix), an imaging drug used for the diagnosis or surgery of bladder cancer, at the 43rd Congress of the Société Internationale d’Urologie (SIU) in 2023 (Press release, Asieris Pharmaceuticals, OCT 12, 2023, View Source [SID1234635904]). The study confirmed that, in the Chinese patient, APL-1706 in combination with blue light cystoscopy (BLC) outperformed white light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases of carcinoma in situ (CIS), and exhibited good tolerability.
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The study included a total of 158 patients, with 37 patients in the training cases group. Six patients were randomly assigned to the standard WLC control group, and one patient dropped out, leaving 114 patients in the full analysis set (FAS). Among the 97 patients diagnosed with Ta, T1, and CIS (mFAS), compared to standard WLC, a total of 42 patients (43.3%) detected one or more additional bladder cancer lesions through the combination of APL-1706 and blue light cystoscopy (p<0.0001). Among the 114 patients, 13 patients (11.4% ,13/114) had CIS lesions, and among these, 11 patients (84.6%, 11/13) had additional CIS lesions detected under 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. The false positive rates for BLC and WLC were 23.2% and 16.0%, respectively. A total of 95 patients reported 200 adverse events, all of which were mild to moderate, with 95.5% of them unrelated to APL-1706. There were no serious adverse events reported.
Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, "APL-1706 is currently the only approved optical imaging for assisting in the diagnosis and surgery of bladder cancer worldwide. The data presented at the SIU conference further validates the tremendous clinical value of APL-1706. We believe that this innovative drug will bring significant benefits to bladder cancer patients in the local market. We will actively advance the related regulatory submissions in China, expediting its market entry to benefit more patients as soon as possible."
In January 2021, Asieris entered into a license agreement with Photocure ASA (Photocure, OSE:PHO), a bladder cancer specialty company based in Oslo, Norway, and obtained the exclusive registration and commercialization rights of Hexvix in mainland China and Taiwan.