Positive Phase III Results for First Non-Surgical Cervical HSIL Treatment

In a significant development for women's health, Asieris Pharmaceuticals has announced positive results from a Phase III global clinical study on a groundbreaking non-surgical treatment for cervical high-grade squamous intraepithelial lesions (HSIL). The product, APL-1702, has shown remarkable efficacy and safety, marking a world-first in non-invasive therapies for this condition.

The multicenter, randomized, double-blinded, placebo-controlled study was conducted under the leadership of Dr. Jinghe Lang from the Peking Union Medical College Hospital. It aimed to assess the effectiveness and safety profile of APL-1702, a novel cold light photodynamic drug-device combination. The primary outcome measure was the response rate at six months post-treatment, which was defined as the normalization of cervical epithelial tissue pathology or a downgrade to a low-grade lesion along with clearance of baseline HPV.

Between November 2020 and July 2022, 402 patients from China, Germany, the Netherlands, and other countries participated in the study. The results revealed that the APL-1702 group achieved a statistically significant response rate increase of 89.4% compared to the placebo group, showcasing a compelling therapeutic impact. Notably, APL-1702 also demonstrated a 103.9% higher clearance rate of high-risk HPV types 16 and/or 18. The treatment was well-tolerated with a comparable incidence of adverse events between the treatment and control groups, most of which were mild and resolved without intervention.

Cervical cancer, the fourth most common cancer among women globally, is primarily caused by persistent HPV infection leading to precancerous cervical lesions. The "Global Cancer Statistics 2020" report highlighted the severity of the issue, with 604,127 new cases and 341,831 deaths worldwide in 2020. In China, cervical cancer ranks second among malignant tumors among women, with the "National Cancer Report 2024" indicating 150,700 new cases and 55,700 deaths in 2022.

The current standard of care for high-grade cervical lesions includes invasive procedures such as LEEP and cold knife conization, which carry risks of bleeding, infection, and cervical damage, potentially leading to preterm birth and miscarriage. Long-term monitoring is necessary even after these treatments due to the risk of disease persistence or recurrence. The development of non-surgical treatments like APL-1702 is therefore crucial for preserving the cervix and reducing the risk of long-term complications.

Professor Chen Fei from Peking Union Medical College Hospital has expressed great satisfaction with the study's outcomes, emphasizing the importance of treating HSIL as a preventative measure against cervical cancer. The emergence of APL-1702 is seen as a significant advancement for patients seeking non-invasive treatment options.

Professor Qiao Youlin, a member of the WHO Global Expert Group for Cervical Cancer Elimination, also lauded the innovation, noting its potential to address the treatment gap, contribute to cervical cancer prevention and control, and promote fertility-friendly options.

Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, expressed pride in the study's results and the potential of APL-1702 to strengthen cervical cancer prevention and control efforts. The company is preparing to submit a new drug application for APL-1702 in China in Q2 2024 and is progressing with product development for international markets.

APL-1702, under the brand name Cevira®, represents a significant step forward in the non-surgical treatment of cervical precancerous lesions, particularly beneficial for young women of reproductive age. Asieris Pharmaceuticals, in collaboration with Photocure ASA, is committed to bringing this innovative treatment to a global audience, aiming to improve patient outcomes and contribute to the broader goal of cervical cancer elimination by 2030.