Shanghai, China, April 8, 2024 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, unveiled the results of the drug and equipment performance from the Phase III clinical study of its bladder cancer diagnostic and management drug APL-1706 in combination with HD 4K blue light cystoscopy at the 39th Annual Meeting of the European Association of Urology (EAU) in 2024 in the form of a poster presentation.
The study is a prospective, self-controlled, multicenter Phase Ⅲ trial aimed at comparing the detection rate and safety of APL-1706 and blue light cystoscopy (BLC) versus white light cystoscopy (WLC) in patients with non-muscle invasive bladder cancer (NMIBC). Primary endpoint was set for additional detection rate of one or more lesions including tumors with stages of carcinoma in situ (CIS), Ta, and T1 by APL-1706 BLC compared to WLC. The study reached its primary endpoint in August 2023. The new drug application (NDA) for APL-1706 was accepted by the National Medical Products Administration (NMPA) in November 2023.
158 patients were enrolled and 114 patients were included in the full analysis set. Of 97 patients with Ta, T1, or CIS, 42 patients (43.3%) had at least one lesion found by BLC but not by WLC (p<0.0001). 13 patients (11.4%) had CIS, of which 11 patients (84.6%) showed additional CIS lesions only by BLC but not by WLC. Detection rates are presented in Table 1. Physicians rated image quality in BLC mode excellent (88.6%) and good (11.4%). Overall satisfaction with device performance was reported as excellent (83.8%) and good (12.4%).
Table1
This study confirms the superiority of HAL BLC over WLC in the detection of bladder cancer despite of improved WLC using HD 4K equipment. In particular, additional high-risk CIS lesions have been identified in 85% of all CIS patients only by HAL BLC, which are difficult to see by WLC. Quality of resection is still a key cornerstone in the treatment of NMIBC of which BLC remains a crucial part even with further development of WLC imaging.
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health to preserve patient’s dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.
