Efficacy and safety of tislelizumab combined with chemotherapy for locally advanced penile cancer: a prospective, single-arm clinical study.

[BACKGROUND] Locally advanced penile squamous cell carcinoma (PSCC) generally has a poor prognosis. Our aim was to access the efficacy and safety of programmed cell death protein 1 (PD-1) inhibitor tislelizumab combined with chemotherapy for locally advanced PSCC.

[METHODS] In this prospective, single-arm clinical study, eligible patients received Nab-Paclitaxel (175 mg/m2 D1), Cisplatin (70 mg/m in 3 days), Bleomycin (30 mg D1, 8), and tislelizumab (200 mg D1) every 3 weeks for 4-6 cycles, followed by consolidative treatment if necessary. The primary endpoint was objective response rate (ORR) and progression-free survival (PFS).

[RESULTS] Of all 20 enrolled patients, 75.0% (15/20) had a history of previous penectomy and were recurrence cases. The median treatment cycles was 4 (range: 2-6). The ORR reached 75.0%. 35.0% (7/20) of patients underwent consolidative surgery, and 55.0% (11/20) received maintenance immunotherapy (median 7 cycles). At median follow-up of 29.3 months, the median PFS and the median overall survival (OS) were 12.5 months (95% CI 7.4-NE), 22.8 months (95% CI 13.7-NE), respectively. Grade≥3 treatment-related adverse events (TRAEs) were observed in 40% (8/20) patients. No treatment-related deaths occurred.

[CONCLUSIONS] The combination of tislelizumab with chemotherapy demonstrated promising antitumor efficacy in locally advanced PSCC, with a manageable safety profile.