KEYNOTE-629
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.
Overview
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.
- 34 out of 100 people had their tumour shrink with Pembrolizumab.
- 50 out of 100 people had their tumour shrink with Pembrolizumab.
- 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: Recurrent or metastatic, and separately locally advanced, cutaneous squamous cell carcinoma: pembrolizumab. 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.
159 participants 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 |
Similar pages
not linked directly; found by shared links- TrialEMPOWER-CSCC-1
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, PD-1, Immune checkpoint inhibitors.
- TrialKEYNOTE-017 (Cancer Immunotherapy Trials Network 09)
Shares Merck & Co. (MSD), PD-1, Immune checkpoint inhibitors, Pembrolizumab.
- TrialAn Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Pembrolizumab.
- TrialStudy of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma.
- TrialKEYNOTE-170
Shares Merck & Co. (MSD), PD-1, Immune checkpoint inhibitors, Pembrolizumab.
- TrialStudy Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma.
- TreatmentCosibelimab
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Immune checkpoint inhibitors.
- TrialA Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
Shares Merck & Co. (MSD), Pembrolizumab.