According to phase 3 study results presented at the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancers in San Diego, California, APL-1702 demonstrated long-term efficacy and safety among patients with cervical histologic high-grade squamous intraepithelial lesions. APL-1702 is an integrated combination drug-device containing hexaminolevulinate hydrochloride and innovative photodynamic therapy.

In this prospective, multicenter study, 402 patients were randomized on a 2-to-1 basis to receive either APL-1702 (5% hexaminolevulinate hydrochloride ointment plus 125 mg photodynamic therapy J/cm2 administered over 4.6 hours), or placebo for no more than twice in a 6-month period. The primary end point was 6-month response rate. The proportion of patients who were HPV-positive, HPV16-positive, and or HPV18-positive, the proportion of patients with clearance of HPV 6-months post-treatment, and the proportion of patients with histological regression served as secondary end points. Extension end points to determine long-term efficacy and safety identified the proportion of patients who had low-grade squamous intraepithelial lesions without clearance of baseline HPV at 6-months who then responded at 12-months and the proportion of patients who responded at 6-months with continued regression at 12-months.

At analysis, the 6-month response rate was 41.1% in the APL-1702 arm and 21.7% in the placebo arm (P = .0001). High-risk HPV16 and/or 18 clearance rate was 31.4% in the APL-1702 arm and 15.4% in the placebo arm (P = .01). At 12-month extended follow-up, 40% of patients with low-grade squamous intraepithelial lesions who were HPV-positive at 6-months became responders, and 54.9% of those who responded at 6-months maintained response at 12-months. Response rate was 38% with 56 maintained responders and 40 new responders. 

Mild treatment-emergent adverse events were reported by 56.8% of patients in the APL-1702 arm and 56% of patients in the placebo arm. Treatment-related adverse events occurred in 31.6% of patients in the APL-1702 arm and 26.1% of patients in the placebo arm. Serious adverse events occurred in 1.5% of patients in both treatment arms. During the extension period, treatment-emergent adverse events and serious adverse events were reported by 23.6% and 1.9% of patients, respectively.

Study authors concluded “APL-1702 provides an innovative, non-surgical treatment option by showing good efficacy with an acceptable safety profile in a phase III global study for cervical HSIL patients.” 

Source: 

Chen F, Lang J, Hillemanns P, et al. APL-1702 long-term efficacy and safety for cervical histologic, high-grade squamous intraepithelial lesions: Results from a randomized, phase III, global study. Presented at the SGO 2024 Annual Meeting; March 16-18, 2024. San Diego, California