Asieris Pharmaceuticals, in partnership with Photocure ASA, has announced the publication of subgroup analysis data from its Phase III clinical trial of Cevira® (APL-1702) for the non-surgical treatment of cervical High-Grade Squamous Intraepithelial Lesion (HSIL). The data, presented at the 27th Chinese Society of Clinical Oncology (CSCO) Annual Meeting, highlights the efficacy and safety of APL-1702 across different age subgroups, with a focus on pathological regression and HPV clearance rates. The study suggests a significant therapeutic potential of APL-1702 in the HSIL population aged 20 to 40 years.
The Phase III trial was a prospective, randomized, double-blind, placebo-controlled, multi-center study. The study met its primary efficacy endpoint and demonstrated a good safety profile. The results presented at CSCO focused on the pathological regression rate, defined as the proportion of subjects with a pathological regression to CIN1 or normal tissue at the 6th month, across different age subgroups.
Efficacy in Younger Age Groups
The subgroup analysis revealed that both the "≥20 and <30 years" and the "≥30 and <40 years" subgroups experienced a 15% to 20% increase in the pathological regression rate in the APL-1702 group compared to the placebo control group. Notably, no cervical cancer events were reported in these age groups, underscoring the therapeutic potential of APL-1702 for HSIL in younger women.
HPV Clearance Rates
In the "≥20 and <30 years" age group, APL-1702 demonstrated enhancements in the overall HPV clearance rate, HPV16-positive clearance rate, and HPV16/18-positive clearance rate compared to the placebo control group. This suggests that APL-1702 not only facilitates the regression from HSIL to LSIL but also induces the clearance of high-risk HPV infections.
Limitations and Future Directions
The study acknowledged that the number of patients in the "<20 years" and "≥40 years" age groups were limited, necessitating further validation studies with larger sample sizes to confirm the findings in these populations.
About Cevira (APL-1702)
Cevira® (APL-1702) is a photodynamic drug-device combination product currently in development. Based on the principles of photodynamic therapy, Cevira utilizes a photosensitizer in combination with light activation to produce a therapeutic effect as a non-surgical treatment for HSIL in patients aged 18 years and above, excluding carcinoma in situ. Photocure developed Cevira through Phase I and Phase II trials, and the global rights for development and commercialization were out-licensed to Asieris Meditech Co., Ltd in 2019. Asieris initiated the Phase III clinical trial for APL-1702 (Cevira) in November 2020, which achieved its primary endpoint in September 2023 (Clinical trial number: NCT04484415). The new drug application for APL-1702 was accepted by the National Medical Products Administration (NMPA) in May 2024.
