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.
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.
Response
Response
CI = confidence interval.
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 |
Response
Response
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.
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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.
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%