EMPOWER-CSCC-1
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.
Overview
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.
- 47 out of 100 people had their tumour shrink with Cemiplimab.
- 46 out of 100 people had their tumour shrink with Cemiplimab.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Locally advanced or metastatic cutaneous squamous cell carcinoma not suitable for curative surgery or radiotherapy: cemiplimab in three dose groups. People in a different situation may not see the same effect.
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 participants 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 |
Similar pages
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