A Multicenter, Phase II Study of Photodynamic Therapy Using Talaporfin Sodium for Cervical Intraepithelial Neoplasia

Talaporfin sodium, a second-generation photosensitizer developed in Japan, is a medicine that requires a shorter sun-shade period compared to the first-generation. The efficacy and safety of PDT using talaporfin sodium (T-PDT) for CIN have not been determined.We report a single-arm phase II study to evaluate the efficacy and safety of T-PDT. The single-arm, phase II, multicenter clinical study was conducted from December 2019 to February 2023. Of the 79 patients who underwent T-PDT, we analyzed 77 patients (CIN3: 70 and CIN2: 7). The drug T-PDT 40 mg/m2 was administered intravenously, and four to six hours later, laser light irradiation was performed on the lesion. The complete response rate (not-HSIL) was 100%. The high-risk HPV negative conversion rate was 82.4%. The safety assessment revealed no serious adverse events. Four patients experienced four Grade 3 or above adverse events. This study suggested the efficacy and safety of T-PDT.