Novel Nonsurgical Treatment Shows Efficacy in Cervical Lesion Treatment
APL-1702 is the first nonsurgical treatment for cervical high-grade intraepithelial lesions to show clinical efficacy in a phase 3 trial, making it a potentially groundbreaking option in the field.
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APL-1702 (Cevira) demonstrated statistically significant efficacy and a favorable safety profile for the treatment of patients with cervical high-grade squamous intraepithelial lesions (HSIL) in a phase 3 study, marking it as the first nonsurgical treatment with proven efficacy for this intent-to-treat population.1,2
The APL-1702 cohort demonstrated an improvement of 89.4% (41.1% vs 21.7%; P =.0001) compared with placebo. Patients in the APL-1702 group also had better clearance of high-risk HPV16 and/or HPV18 virus compared with the placebo group, with a 103.9% improvement (31.4% vs 15.4%). Regarding safety, treatment-emergent adverse events (TEAEs) were comparable between the study arms. Most TEAEs were mild and did not require treatment.2
The findings from the study, which was conducted in China, Germany, and the Netherlands, were presented at the 2024 Society for Gynecologic Oncology Annual Meeting on Women’s Cancer and the 2024 European Research Organization on Genital Infection and Neoplasia Congress. The data will be included in a new drug application in China, which is expected in Q2 2024. Development of the agent outside of China is also in progress.
"We are very pleased to see the strong results of this randomized controlled phase III clinical trial in which [APL-1702] demonstrated clear benefit in patients with HSIL. Based on the results, treatment with [APL-1702] has the potential to fill an unmet clinical need as an alternative to conventional surgical therapies for HSIL", said Anders Neijber, chief medical officer of Photocure, in a press release.1 "At present, Photocure teams are supporting Asieris' to prepare the new drug application for [APL-1702] in China, with the goal of bringing this innovative therapy to a larger number of patients as soon as possible."
As the current standard of care in this population are the invasive loop electrosurgical excision procedure (LEEP) and cold knife conization, which can lead to pregnancy complications and require long-term follow-up,2 a nonsurgical option presents a radically different option in the treatment landscape.
About the Phase 3 Study of APL-1702 in Cervical HSIL
APL-1702 is a novel cold light photodynamic drug-device combination being evaluated in a phase 3, global, randomized, double-blinded, placebo-controlled trial.2 The primary end point of the study is the proportion of responders at 6 months after initial treatment.
Here, response is defined as the conversion of high-grade lesions to normal or low-grade while achieving baseline HPV clearance. HPV clearance is a notable metric, as the main cause of cervical HSIL is HPV infection.
“I am extremely pleased with the results of this study. Treating HSIL serves as the final barrier against cervical cancer. Previous international studies on HSIL have not been successful, but this study, utilizing a multicenter trial design and strict definition of efficacy endpoints, has achieved positive results, which is no easy feat. As a clinician, I have encountered many HSIL patients who desire to preserve their intact cervix while receiving treatment. The emergence of APL-1702 will fulfill the wishes of these patients, allowing them to avoid or delay cervical trauma to the maximum extent possible,” said Chen Fei, professor and chief physician of the Department of Obstetrics and Gynecology at Pekin Union Medical Hospital, said in a press release.2
