Loading
EMPOWER-CSCC-1 showed that cemiplimab shrinks almost half of advanced skin squamous cell cancers, most of them for years, and it gave this cancer its first approved drug.
EMPOWER-CSCC-1 was a single-arm phase 2 trial of the PD-1 antibody cemiplimab in cutaneous squamous cell carcinoma that was metastatic or locally advanced and beyond cure with surgery or radiotherapy. Cutaneous squamous cell carcinoma carries one of the highest mutation burdens of any cancer because of ultraviolet damage, and it is commoner in immunosuppressed people, both of which pointed to immunotherapy.
In the first report (NEJM 2018) the objective response rate in the metastatic group was 47 percent, and in the pooled analysis of 193 patients across the three groups (2021) it was 46 percent with complete responses in 16 percent; the median duration of response had not been reached. Toxicity was that of PD-1 blockade generally.
Cemiplimab was approved for advanced cutaneous squamous cell carcinoma in September 2018, the first systemic therapy for the disease, and the trial opened the way to pembrolizumab (KEYNOTE-629), cosibelimab, neoadjuvant cemiplimab and the adjuvant C-POST trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
193 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate (metastatic group)primary | Cemiplimab | 59 | 47% | - | - | link |
| Objective response rate (pooled analysis) | Cemiplimab | 193 | 46% | - | - | link |
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.
This is the paper Europe PMC returns for registry id NCT02760498 with the most citations, so it is the natural first reading for anyone following the EMPOWER-CSCC-1 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
PD-1 blockade is the first-line systemic treatment for advanced cutaneous squamous cell carcinoma, including on the lip, and cemiplimab has since moved into neoadjuvant and adjuvant use.
Shares CK-301-101, Radiotherapy for skin cancer, Neoadjuvant cemiplimab for resectable stage II to IV skin squamous cell carcinoma, C-POST (cemiplimab after surgery and radiotherapy for high-risk skin squamous cell carcinoma).
Shares Cemiplimab for kidney transplant recipients with advanced skin squamous cell carcinoma, Skin cancer after an organ transplant, Advanced cutaneous squamous cell carcinoma, Cemiplimab.
Shares Advanced cutaneous squamous cell carcinoma, Regeneron, Cemiplimab, Cutaneous squamous cell carcinoma.
Shares Sanofi, Regeneron, Cemiplimab, Tumour mutational burden (TMB).
Shares Cemiplimab for kidney transplant recipients with advanced skin squamous cell carcinoma, Skin cancer after an organ transplant, Cutaneous squamous cell carcinoma, Skin cancer (all types).
Shares Sanofi, Regeneron, Cemiplimab, PD-1.
Shares TROG 05.01 (chemotherapy added to radiotherapy after surgery for high-risk skin squamous cell carcinoma), Radiotherapy for skin cancer, C-POST (cemiplimab after surgery and radiotherapy for high-risk skin squamous cell carcinoma), Cutaneous squamous cell carcinoma.
Shares PD-1 blockade with cemiplimab in advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1), Advanced cutaneous squamous cell carcinoma, Skin cancer (all types).