KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
Clinical Trial Results
Advanced cSCC
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
Clinical Findings from KEYNOTE-629
Objective Response Rate (ORR) - Recurrent or Metastatic Cohort
In 105 patients treated with KEYTRUDAResponse
Response
CI = confidence interval.
Duration of Response (DOR) - Recurrent or Metastatic Cohortc
KEYTRUDA |
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Median DORNot reached(range: 2.7–30.4+ months)d |
Patients with responses lasting ≥6 months76% |
Patients with responses lasting ≥12 months68% |
Median follow-up time23.8 months |
Objective Response Rate (ORR) - Locally Advanced Cohort
In 54 patients treated with KEYTRUDAResponse
Response
Duration of Response (DOR) - Locally Advanced Cohortg
KEYTRUDA |
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Median DORNot reached(range: 1.0+–17.2+ months)h |
Patients with responses lasting ≥6 months81% |
Patients with responses lasting ≥12 months37% |
Median follow-up time13.4 months |
+ Denotes ongoing response.
Study Design for KEYNOTE-629
Study Overview
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Study Arm
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End Points
Major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) as assessed by BICR according to RECIST v1.1, modified to follow the maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Patient Characteristics
The trial excluded patients with autoimmune disease or a medical condition that required immunosuppression.
Patients with recurrent or metastatic cSCC (n=105)
- Median age: 72 years
- Age range: 29-95
- Male: 76%
- White: 71%
- ECOG PS 0: 34%
- Prior radiation: 74%
Patients with locally advanced cSCC (n=54)
- Median age: 76 years
- Age range: 35-95
- Male: 72%
- White: 83%
- ECOG PS 0: 41%
- Prior radiation: 63%