Journal Article DKFZ-2026-02692

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Phase II Study of Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous Cell Carcinoma: Final Analysis.

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2026
American Society of Clinical Oncology Alexandria, Va.

Journal of clinical oncology nn, nn () [10.1200/JCO-26-02166]
 GO

Abstract: We previously reported the results of a multicenter phase II trial (ClinicalTrials.gov identifier: NCT04154943) of neoadjuvant cemiplimab in resectable stage II to IV cutaneous squamous cell carcinoma (CSCC), in which the pathologic complete response (pCR) rate was 51%. At the 19-month follow-up, estimated 12-month event-free survival (EFS) was 89%, with 11 EFS events. In this study, we report final EFS and overall survival (OS) at a median follow-up of 54 months. Overall, 16 EFS events occurred at final analysis. There were no new disease recurrence events. The five new EFS events were all comorbidity-related deaths without CSCC recurrence. Overall estimated 54-month EFS was 76.2% (81.5% in patients with pCR, 88.9% in patients with major pathologic response, 100% in patients with partial pathologic response, and 45.7% in nonresponders/not-evaluable patients). Among 40 patients with pCR, none had experienced disease recurrence. Overall estimated 54-month OS was 79.4%. No new grade ≥3 treatment-emergent adverse events occurred. The final analysis demonstrates durable EFS and OS, no late recurrences, and no new safety signals with neoadjuvant cemiplimab.

Classification:

Note: #NCTZFB9# / epub

Contributing Institute(s):
  1. Koordinierungsstelle NCT Dresden (DD04)
Research Program(s):
  1. 899 - ohne Topic (POF4-899) (POF4-899)

Appears in the scientific report 2026
Database coverage:
Medline ; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Current Contents - Life Sciences ; Essential Science Indicators ; IF >= 40 ; JCR ; NationallizenzNationallizenz ; PubMed Central ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection
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 Record created 2026-10-30, last modified 2026-10-30



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