On January 29, 2024 Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases, reported the results of the Phase III clinical trial and real-world study for APL-1706, a drug designed for the diagnosis and management of bladder cancer (Press release, Asieris Pharmaceuticals, JAN 29, 2024, View Source [SID1234639689]). This significant announcement was made at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO-GU), featuring a poster presentation (Abstract No. 593).

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The study incorporated 158 patients in a randomized controlled trial (RCT) and 19 patients in a real-world study (RWS). Notably, the use of Blue Light Cystoscopy (BLC) in conjunction with APL-1706 significantly improved the detection of bladder cancer lesions compared to traditional white light cystoscopy (WLC). In the RCT, 43.3% of patients (42 out of 97) diagnosed with Ta, T1, or CIS and 33.3% in the RWS (4 out of 12 patients) had at least one lesion detected by BLC that was not identified by WLC (p<0.0001). Additionally, in the RCT, 9.6% (11 out of 114) and in the RWS, 7.1% (1 out of 14) of CIS patients had additional lesions detected under BLC that were not found using WLC.

The detection rates for PUNLMP, CIS, Ta, T1, and T2 ~ T4 tumors in the RCT were notably high with BLC, reaching 94.7%, 100%, 98.2%, and 100% respectively, compared to the WLC detection rates of 42.1%, 76.1%, 91.2%, and 100%. Similarly, in the RWS, BLC detection rates for these tumor stages were 100%, compared to WLC rates of 50%, 81%, and 100%. These findings confirm that APL-1706 combined with BLC offers superior detection of bladder cancer in the Chinese population, especially in CIS patients, while maintaining good tolerability.

Following these encouraging results, the New Drug Application (NDA) for APL-1706 was accepted by the National Medical Products Administration (NMPA) in November 2023.