A Multicenter Phase II Study on Photodynamic Therapy Using Talaporfin Sodium ( ME2906 ) and a Semiconductor Laser ( PNL6405CIN ) for Intraepithelial Tumors of the Cervix

Purpose Conization for high‐grade cervical intraepithelial neoplasia (CIN2–3) often harms obstetric outcomes. Photodynamic therapy (PDT) with talaporfin sodium provides a cervix‐sparing alternative with short photosensitivity. We investigated the efficacy and safety of talaporfin‐PDT for CIN2–3. Methods We conducted a prospective, multicenter, single‐arm phase II trial (jRCT2041190087) in women ≥ 20 years with biopsy‐proven CIN2–3. Patients received talaporfin sodium (40 mg/m 2 ) and 664‐nm laser irradiation. Efficacy was evaluated by cytology/histology from weeks 12 to 24; the primary endpoint was complete response (CR) versus an 85% threshold. Safety, HPV status, cervical length, and reproductive outcomes were monitored. Results Of 88 enrolled, 79 were treated and 77 (CIN2 = 7; CIN3 = 70; median age 32 years; 93.5% desiring future pregnancy) were evaluable. CR was achieved in all 77 (100%; lower 95% CI: 96.2%), including 95.8% in CIN3. High‐risk HPV clearance occurred in 82.4%. One recurrence (1.3%) was observed. No serious adverse events occurred; four grade ≥ 3 events resolved. Cervical length was preserved. Eleven pregnancies occurred, yielding eight full‐term deliveries. Conclusions Talaporfin‐PDT showed excellent efficacy, safety, and fertility preservation in CIN2–3, supporting its potential as a non‐excisional alternative. Trial Registration This study was registered in the Japan Registry of Clinical Trials (jRCT) under the identifier jRCT2041190087