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KEYNOTE-629 showed that pembrolizumab shrinks about a third of recurrent or metastatic skin squamous cell cancers and half of locally advanced ones, giving a second immunotherapy option after cemiplimab.
KEYNOTE-629 was a single-arm phase 2 trial of pembrolizumab with two cohorts: recurrent or metastatic cutaneous squamous cell carcinoma, and locally advanced disease not curable by surgery or radiotherapy.
In the recurrent or metastatic cohort of 105 patients the objective response rate was 34 percent (JCO 2020); in the locally advanced cohort of 54 patients it was 50 percent, with responses in both cohorts lasting well beyond a year in most responders. Toxicity matched pembrolizumab in other cancers.
Pembrolizumab was approved for recurrent or metastatic cutaneous squamous cell carcinoma in June 2020 and for locally advanced disease in July 2021, making it the second PD-1 antibody available and confirming that the EMPOWER-CSCC-1 result was a class 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.
159 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate (recurrent or metastatic cohort)primary | Pembrolizumab | 105 | 34% | - | - | link |
| Objective response rate (locally advanced cohort) | Pembrolizumab | 54 | 50% | - | - | link |
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 KEYNOTE-629: pembrolizumab monotherapy for recurrent or metastatic cutaneous squamous cell carcinoma, Advanced cutaneous squamous cell carcinoma, Skin cancer (all types).
Shares Radiotherapy for skin cancer, C-POST (cemiplimab after surgery and radiotherapy for high-risk skin squamous cell carcinoma), Cutaneous squamous cell carcinoma, Skin cancer (all types).
Shares CK-301-101, Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Immune checkpoint inhibitors.
Shares CK-301-101, Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma.
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Skin cancer (all types), PD-1.
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Immune checkpoint inhibitors.
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Immune checkpoint inhibitors.