EPIC-A: Phase II trial of cemiplimab plus standard of care chemotherapy followed by maintenance cemiplimab in locally advanced or metastatic penile carcinoma.

作者：Amit Bahl, Amarnath Challapalli, Balaji Venugopal, Mehran Afshar, Constantine Alifrangis, Alastair Thomson, Anna Tran, Andrew Hudson, Christopher Kent, Jim Barber, Helen Clare Dearden, R. Pearson, Vivekanandan Kumar, Robert Wade, Alicia Bravo, Emily Foulstone, Paul White · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.5_suppl.1 · 被引用次数：11 · 研究领域：Genital Health and Disease

1 Background: Platinum-based combination chemotherapy remains the Standard of Care (SoC) treatment for patients with locally advanced/metastatic penile cancer (la/mPC). Prognosis is poor and treatment options are limited. PDL1 is upregulated in 40–60% of cases making a case for immunotherapy as a treatment option for la/mPC. PD-1 inhibitor cemiplimab is approved for patients with locally advanced or metastatic cutaneous SCC. We evaluated efficacy and safety of cemiplimab in combination with SoC chemotherapy in patients with la/mPC. Methods: EPIC-A is a National Cancer Research Network badged phase II non-randomised multi-centre trial evaluating the efficacy and safety of cemiplimab plus platinum-based chemotherapy as first-line treatment in la/mPC. Patients with la/mPC (Tany,N2-3,M0 or T4,Nany,M0 or M1) not amenable for radical treatment received: cemiplimab 350mg IV D1 every 3 weeks (Q3W) + SoC chemotherapy cisplatin/5FU (PF, 27 patients) or docetaxel, ifosfamide, cisplatin (TIP, 2 patients) for 4 cycles followed by cemiplimab alone 350mg IV Q3W up to a total of 34 cycles. The primary end point was investigator assessed Clinical Benefit Rate (CBR) at 12 weeks using RECIST 1.1. The study was designed as an A’Hern (2001) study α=0.05 + power (1-β)=0.8, assuming 25% meeting the clinical end point is a poor treatment (p0=0.25) and 50% is a good treatment (p1=0.5). Assuming a 10% drop out rate, 29 patients were recruited. Results: 29 patients from 11 UK sites were enrolled from J...