China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has revealed that a Phase III study for Hexvix (APL-1706) in bladder cancer diagnosis has successfully reached its primary endpoint.
Study Design and Outcomes
The prospective, subject-controlled, multi-center Phase III study compared the detection rates of APL-1706 combined with blue light cystoscopy and white light cystoscopy for bladder cancer. The primary endpoint focused on the proportion of subjects with one or more additional bladder cancer lesions (Ta, T1, and CIS stages) detected by Hexvix combined with blue light endoscopy compared to white light endoscopy. The study included a total of 158 patients, and the completed statistical analysis has confirmed the achievement of the primary endpoint.
Hexvix’s Role in Bladder Cancer Diagnosis
Hexvix is the world’s only approved agent for assisting in the diagnosis or surgery of bladder cancer and has been shown to effectively improve the detection rate of non-muscle invasive bladder cancer (NMIBC) when combined with blue light cystoscopy. The positive results from the Phase III study will support the upcoming New Drug Application (NDA) filing with regulatory authorities, potentially leading to a new standard in bladder cancer detection and management.-Fineline Info & Tech
