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.

2 days ago

Review • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker

PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • PD-1 (Programmed cell death 1) • TGFB1 (Transforming Growth Factor Beta 1)

Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc)

Immune Checkpoint Blockade Therapy for Advanced Cutaneous Squamous Cell Carcinoma in Immunosuppressed Patients, Transplant Recipients, and Individuals with Hereditary Syndromes: A Narrative Review. (PubMed, Cancers (Basel))

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.

8 days ago

Review • Journal • Checkpoint inhibition • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker

TMB (Tumor Mutational Burden)

TMB-H

Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc)

Real-World Data of First-Line Cemiplimab Monotherapy for Metastatic Non-Small Cell Lung Cancer (NSCLC) with PD-L1 Expression ≥ 50%: A National Spanish Multicentric Cohort (CEMI-SPA Study). (PubMed, Cancers (Basel))

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.

8 days ago

Clinical • Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker

PD-L1 (Programmed death ligand 1)

PD-L1 expression • PD-L1 overexpression

Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc)

CEMIQUID: Cemiplimab Plus Imiquimod and Laser Therapy As Neoadjuvant Treatment In Cutaneous Basal Cell Carcinoma (clinicaltrials.gov)

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

8 days ago

New P1/2 trial

Libtayo (cemiplimab-rwlc) • Zyclara (imiquimod)

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer (clinicaltrials.gov)

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

9 days ago

Trial completion date • Trial primary completion date • IO biomarker

Libtayo (cemiplimab-rwlc) • CDX-1140

14d

A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer (clinicaltrials.gov)

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

14 days ago

Enrollment closed • Trial primary completion date • Checkpoint inhibition • Tumor mutational burden

PD-L1 (Programmed death ligand 1)

Libtayo (cemiplimab-rwlc)

15d

INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) (clinicaltrials.gov)

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

15 days ago

Trial completion date • Trial primary completion date

temozolomide • Libtayo (cemiplimab-rwlc) • INO-5401 • rocakinogene sifuplasmid (INO-9012)

15d

PALACE: Cemiplimab Trial According to ctDNA Levels (clinicaltrials.gov)

P2, N=63, Recruiting, Fundación GECP | Not yet recruiting --> Recruiting | Initiation date: Apr 2025 --> Jul 2025

15 days ago

Enrollment open • Trial initiation date • Circulating tumor DNA

carboplatin • paclitaxel • Libtayo (cemiplimab-rwlc)

16d

LAG-MAPS: Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma (clinicaltrials.gov)

P2, N=126, Not yet recruiting, Intergroupe Francophone de Cancerologie Thoracique

16 days ago

New P2 trial

cisplatin • carboplatin • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)

16d

ARCH: A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy (clinicaltrials.gov)

P3, N=390, Recruiting, ETOP IBCSG Partners Foundation | Not yet recruiting --> Recruiting

16 days ago

Enrollment open

PD-L1 (Programmed death ligand 1)

Libtayo (cemiplimab-rwlc)

17d

A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors (clinicaltrials.gov)

P1/2, N=500, Recruiting, Biohaven Therapeutics Ltd. | N=280 --> 500

17 days ago

Enrollment change • First-in-human

Libtayo (cemiplimab-rwlc)

17d

BBI-20233042: Study of BDC-3042 as Single Agent and in Combination With Cemiplimab in Patients With Advanced Malignancies (clinicaltrials.gov)

P1, N=17, Terminated, Bolt Biotherapeutics, Inc. | N=147 --> 17 | Trial completion date: Mar 2028 --> Aug 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2026 --> Aug 2025; Sponsor decision

17 days ago

Enrollment change • Trial completion date • Trial termination • Trial primary completion date • First-in-human

Libtayo (cemiplimab-rwlc) • BDC-3042