Asieris Pharmaceuticals announced that the multicenter Phase III global clinical study data of its non-surgical treatment for cervical HSIL product APL-1702 demonstrated significant efficacy and good safety profile, with new advancements in clearance rate of high-risk HPV16 and/or HPV18. Key data from the study were presented in oral presentations at the 2024 European Research Organization on Genital Infection and Neoplasia (EUROGIN) Congress and the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting. APL-1702 is a pioneering cold light photodynamic drug-device combination product, used as a non-surgical therapy for treating cervical HSIL.

This study is a prospective, randomized, double-blinded, placebo-controlled multicenter Phase III global clinical study designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. Primary endpoint of the study is the proportion of responders at 6 months after the initial treatment. Response is defined as the conversion of cervical epithelial tissue pathology to normal or the conversion to low-grade squamous intraepithelial lesion (LSIL) while achieving baseline HPV clearance.

According to the study results, between November 2020 and July 2022, a total of 402 eligible patients from various countries including China, Germany, the Netherlands et al. were randomized and enrolled in this study. The response rate in the APL-1702 treatment group showed a statistically significant improvement of 89.4% (41.1% vs.

21.7%, p = 0.0001) compared to that in the placebo control group, indicating a remarkable therapeutic effect. Additionally, APL-1702 showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the APL-1702 treatment group compared to the control group (31.4% vs. 15.4%).

The incidence of treatment-emergent adverse events (TEAEs) was comparable between the treatment group and the control group, with the majority being mild and self-healing without requiring intervention. The occurrence rates of treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were both low in both groups. According to the "Global Cancer Statistics 2020" report, there were 604,127 new cases of cervical cancer in women worldwide in 2020, with 341,831 deaths, ranking it as the fourth most common cancer among women.

Cervical cancer incidence ranks second among malignant tumors in Chinese women. According to the "National Cancer Report 2024" released by the National Cancer Center, there were 150,700 new cases of cervical cancer in China in 2022, with 55,700 deaths from cervical cancer. The main cause of cervical cancer is persistent infection with human papillomavirus (HPV), which leads to precancerous lesions of the cervix.

Approximately 25% of individuals with HSIL may progress to invasive cervical cancer within 10 years[3]. According to Frost Sullivan analysis, it is projected that by 2030, the number of HSIL patients worldwide and in China will reach 16.6 million and 2.2 million, respectively. With the increasing popularity of dual-cancer screening and cervical cytology tests, more and more patients with cervical precancerous lesions are being detected at early stages before cancer develops, and it is expected that the number of patients will continue to increase.

Women with cervical precancerous lesions have unmet clinical needs for non-surgical therapies. Currently, invasive procedures such as loop electrosurgical excision procedure (LEEP) and cold knife conization remain the primary treatment options for high-grade cervical lesions. However, these surgical treatments are associated with adverse reactions including bleeding, infection, and cervical structural damage, which may lead to complications such as preterm birth and miscarriage.

Furthermore, cervical precancerous lesions require long-term monitoring and management because even after surgical treatment, there is a risk of persistent disease or recurrence, with a higher risk of developing cervical cancer compared to the general population (5 times higher risk of invasive cancer within 10 years). Therefore, post-operative follow-up for at least 25 years is necessary. Importantly, if cervical precancerous lesions recur, subsequent surgical interventions become more challenging and carry higher risks, potentially resulting in total hysterectomy.

Thus, early surgical intervention increases the difficulty of long-term management. Non-surgical therapies that preserve the intact cervix and avoid or delay cervical trauma are of significant importance for the long-term management of patients with cervical precancerous lesions.