# A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6

Source: https://onco.cc/key-papers/paper-empower-cscc-1-j-am-acad-dermatol-2025-update/  
OnCo record `paper-empower-cscc-1-j-am-acad-dermatol-2025-update` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Later report from the EMPOWER-CSCC-1 trial registered as NCT02760498, in Journal of the American Academy of Dermatology (2025); its title describes an updated or longer-term analysis.

## Summary

Background: In the phase 2 EMPOWER-CSCC-1 study (NCT02760498), cemiplimab demonstrated antitumor activity against metastatic cutaneous squamous cell carcinoma (mCSCC) and locally advanced cutaneous squamous cell carcinoma (laCSCC).

Objectives: To report final analysis of weight-based cemiplimab in mCSCC and laCSCC (groups 1 and 2), fixed-dose cemiplimab in mCSCC (group 3), and primary analysis of fixed-dose cemiplimab in mCSCC/laCSCC (group 6).

Methods: Patients received cemiplimab (3 mg/kg intravenously every 2 weeks [groups 1 and 2]) or cemiplimab (350 mg intravenously [groups 3 and 6]) every 3 weeks. The primary end point was objective response rate (ORR). Duration of response (DOR) and progression-free survival (PFS) are presented per protocol, according to post-hoc sensitivity analyses that only include the period of protocol-mandated imaging assessments.

Results: At 42.5 months, ORR for groups 1-3 (n = 193) was 47.2%, estimated 12-month DOR was 88.3%, and median PFS was 26.0 months. At 8.7 months, ORR for group 6 (n = 165 patients) was 44.8%; median DOR and median PFS were not reached. Serious treatment-emergent adverse event rates (grade ≥3) were groups 1-3: 31.1% and group 6: 34.5%.

Limitations: Nonrandomized study, nonsurvival primary end point.

Conclusion: EMPOWER-CSCC-1 provides the largest prospective data on long-term efficacy and safety for anti-programmed cell death-1 therapy in advanced CSCC.

Indexed on Europe PMC as PubMed record 39245360 (DOI 10.1016/j.jaad.2024.06.108). Its abstract cites the registry id NCT02760498, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Journal of the American Academy of Dermatology
- Year: 2025
- DOI: 10.1016/j.jaad.2024.06.108
- Authors: Hughes BGM, Guminski A, Bowyer S, et al.
- What it means: A second publication from the EMPOWER-CSCC-1 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Chosen as a later report by words in its title (updated, long-term, final, overall survival or a year count), not by reading the paper.

## Sources

- J Am Acad Dermatol 2025: https://doi.org/10.1016/j.jaad.2024.06.108
- PubMed: https://pubmed.ncbi.nlm.nih.gov/39245360/
- Europe PMC: https://europepmc.org/article/MED/39245360
- ClinicalTrials.gov NCT02760498: https://clinicaltrials.gov/study/NCT02760498

## Connected records

- trials: [EMPOWER-CSCC-1](https://onco.cc/trials/empower-cscc-1/)

---
JSON: https://onco.cc/api/v1/entities/paper-empower-cscc-1-j-am-acad-dermatol-2025-update.json