Press Release -
Key data from the international multicenter Phase III trial were presented for the first time last week, in oral presentations at the 2024
- Cevira (APL-1702) is a pioneering photodynamic drug-device combination product used as a non-invasive therapy for treating cervical high-grade squamous intraepithelial lesions (HSIL). This study is a large prospective, randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL over 12 months. The primary endpoint of the study is the proportion of responders at 6 months after the initial treatment.
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Between
November 2020 andJuly 2022 , 402 eligible patients from various countries includingChina ,Germany , andthe Netherlands were randomized and enrolled in this study. In terms of the primary efficacy endpoint, the response rate in the APL-1702 group was significantly higher than that in the control group, with an increase of 89.4% (41.1% vs. 21.7%, p = 0.0001), which is considered a highly clinically relevant 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 group compared to the control group (31.4% vs. 15.4%). - The incidence of treatment-emergent adverse events (TEAEs) was comparable between the APL-1702 group and the control group, with the majority being mild and self-resolving without requiring intervention. The occurrence rates of treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were low in both groups.
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The current progress involves ongoing communication with regulatory authorities in
China and preparing for the submission of the new drug application for APL-1702. Additionally, active efforts are being made to advance development of the product outside ofChina .
"We are very pleased to see the strong results of this randomized controlled Phase III clinical trial in which Cevira (APL-1702) demonstrated clear benefit in patients with HSIL. Based on the results, treatment with Cevira has the potential to fill an unmet clinical need as an alternative to conventional surgical therapies for HSIL", said Anders Neijber,
According to the press release, 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. Read Asieris' full media release here: https://asieris.com/breakthrough-in-treatment-of-cervical-high-grade-squamous-intraepithelial-lesion-release-of-positive-results-from-multicenter-phase-iii-global-clinical-study/
Cevira (APL-1702) has potential to become a breakthrough photodynamic drug-device combination product that can offer patients the option of non-surgical treatment of high-grade precancerous lesions of the cervix.
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