Libtayo (cemiplimab-rwlc)

This report conducts a systematic review of four principal studies: ① The KEYNOTE-689 trial was the inaugural study to establish that "pembrolizumab combined with standard therapy" diminishes the risk of disease progression or mortality by 34% in patients with Programmed Cell Death-L1(PD-L1) CPS ≥ 10, resulting in Food and Drug Administration (FDA) approval; ② The NIVOPOSTOP trial revealed that adjuvant nivolumab alongside CRT significantly improved 3-year disease-free survival (DFS) (63.1% vs. 52.5%), with efficacy unaffected by PD-L1 status; ③ The C-POST trial indicated a substantial DFS advantage with adjuvant cemiplimab in high-risk skin squamous cell carcinoma (HR = 0.32);④ The NeoRTPC02 trial innovatively integrated low-dose radiotherapy with immune chemotherapy, achieving a pathological complete response(pCR) rate of 60.9%. Nonetheless, the ideal treatment approach, strategies for reducing radiation dosage, preservation of organ function, and selection of biomarkers necessitate additional confirmation. Future efforts must focus on interdisciplinary collaboration to enhance tailored precision treatment protocols, aiming to improve the 5-year survival rate of HNSCC while maintaining organ function and quality of life.

The patient was admitted and commenced on intravenous methylprednisolone, leading to symptom resolution within 7 days. Understanding the pathophysiological mechanisms underlying these toxicities is essential for optimizing treatment strategies, minimizing adverse effects without compromising ICI efficacy, and ultimately prolonging patient access to immunotherapy. Further research into immune-related dermatological conditions may also provide valuable insights into the molecular mechanisms governing endogenous dermatological diseases, offering new avenues for targeted dermatological therapies.

P2, N=74, Not yet recruiting, Università Vita-Salute San Raffaele

P2, N=44, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Nov 2025 --> Aug 2026

P2, N=160, Recruiting, Fondazione Ricerca Traslazionale

Building on this foundation, the potential clinical value of immune checkpoint inhibitors (cemiplimab, pembrolizumab) in treating advanced cSCC is summarized based on data from relevant clinical trials. This review is distinguished from general tumor immunotherapy reviews by offering dedicated references for cSCC precision immunotherapy. In addition, priority is emphasized for future investigations into combination therapy regimens and the development of personalized tumor vaccines.

Cemiplimab and pembrolizumab are now established systemic therapies, producing durable responses in a proportion of patients. This review summarizes current evidence on the management of advanced cSCC in high-risk and underserved patient groups, integrating trial data, real-world evidence, and contemporary guidelines. It also highlights key gaps in knowledge and outlines future directions, with particular focus on the interplay between host immune status, tumor biology, and therapeutic response.

Cemiplimab demonstrated comparable real-world efficacy and safety to pembrolizumab in patients with advanced NSCLC and PD-L1 ≥ 50%. ECOG performance status emerged as the strongest prognostic factor, highlighting the importance of patient selection in routine clinical practice.

P1/2, N=18, Recruiting, Instituto Oncológico Dr Rosell

P2, N=44, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: May 2027 --> Nov 2027 | Trial primary completion date: May 2027 --> Nov 2027

P2, N=35, Active, not recruiting, University of Southern California | Suspended --> Active, not recruiting | Trial primary completion date: Jun 2026 --> Nov 2025

P1/2, N=52, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026