aCR = Disappearance of all target lesions.1
bPR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.1
cMedian follow-up time of 9.5 months.
dBased on patients (n=36) with a confirmed response by independent review.
+ Denotes ongoing.
87% of patients had received 1 or more prior lines of systemic therapy.
CI = confidence interval; CR = complete response; cSCC = cutaneous squamous cell carcinoma; DOR = duration of response; ORR = objective response rate; PR = partial
response; R/M = recurrent or metastatic.
ECOG PS = Eastern Cooperative Oncology Group performance status.
ePatients with initial radiographic disease progression could receive additional doses of KEYTRUDA during confirmation of progression unless disease progression was symptomatic, rapidly progressive, required urgent intervention, or occurred with a decline in performance status.
- The trial excluded patients with autoimmune disease or a medical condition that required immunosuppression.
- Assessment of tumor status was performed every 6 weeks for the first year, and every 9 weeks during the second year.
- The major efficacy outcome measures were ORR and DOR as assessed by BICR according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
IV = intravenously; Q3W = every 3 weeks; BICR = blinded independent central review; RECIST v1.1 = Response Evaluation Criteria In Solid Tumors v1.1.