Asieris Pharmaceuticals announced the release of Phase III clinical trial data and real-world study data for APL-1706 (compound name: Hexaminolevulinate Hydrochloride for Intravesical Solution), a bladder cancer diagnosis and management drug, at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in the form of a poster presentation (Abstract No. 593). The study included 158 patients enrolled in a randomized controlled trial (RCT), with 37 patients in the training group and 6 patients randomly assigned to the non-Blue Light Cystoscopy (BLC) group, one patient withdrew.

A total of 114 patients were in the full analysis set. Nineteen 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 by BLC but not by white light cystoscopy (WLC) (p<0.0001).

In the RCT, 11 out of 114 (9.6%) CIS patients, and in the RWS, 1 out of 14 (7.1%) CIS patients had additional CIS lesions detected under BLC that were not found by WLC. The BLC detection rates for PUNLMP, CIS, Ta, T1, and T2 ~ T4 tumors in the RCT were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while the WLC detection rates were NA, 42.1%, 76.1%, 91.2%, and 100%. In the RWS, the BLC detection rates for PUNLMP, CIS, Ta, T1, and T2 ~ T4 tumors were NA, 100%, 100%, 100%, and the WLC detection rates were NA, 50%, 81%, 100%, and 100%.

Both the RCT and RWS confirmed that APL-1706 combined with BLC demonstrated superior detection of bladder cancer in the Chinese population compared to WLC, especially in the CIS population, with good tolerability. The new drug application (NDA) for APL-1706 was accepted by the National Medical Products Administration (NMPA) in November 2023.