APL-1706 Phase III and Real-World Data Presented at 2024 ASCO-GU

Asieris Pharmaceuticals, a biopharmaceutical firm with a focus on genitourinary tumor treatments, has unveiled Phase III clinical and real-world research data for their drug APL-1706 at the 2024 ASCO GU conference. The drug, intended for bladder cancer diagnosis and management, was presented through a poster session, showcasing its effectiveness and safety profile.

The clinical trial involved 158 participants, with a training group of 37 and a non-Blue Light Cystoscopy (BLC) group of six, though one participant withdrew. The full analysis set comprised 114 patients, while a real-world study included 19. The study revealed that BLC, when combined with APL-1706, detected significantly more lesions than white light cystoscopy (WLC), particularly in patients with Ta, T1, or CIS. Specifically, in the clinical trial, BLC identified at least one lesion in 43.3% of the 97 patients compared to WLC's 42.1%. The real-world study mirrored these findings with a 33.3% detection rate by BLC against WLC's 50%.

In terms of CIS lesions, BLC detected additional cases that were missed by WLC in both the clinical trial (9.6%) and the real-world study (7.1%). The detection rates for various tumor types by BLC were notably higher than those by WLC, with BLC achieving a 100% detection rate for Ta, T1, and T2-T4 tumors in the clinical trial, and a similar performance in the real-world study.

The National Medical Products Administration (NMPA) accepted the new drug application for APL-1706 in November 2023, marking a significant step towards making the drug available for bladder cancer patients.

Asieris Pharmaceuticals, established in 2010, is dedicated to improving patient dignity through the development of innovative drugs. The company has a robust in-house R&D platform and is committed to bringing first-in-class drugs to market to meet significant unmet medical needs. Asieris is also expanding its pipeline through strategic partnerships and staying abreast of the latest advancements in technology and therapeutics to offer comprehensive diagnostic and treatment solutions globally.