LIBTAYO®, a programmed death receptor-1 (PD-1) inhibitor, is the first and only FDA-approved therapy indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation1
ORR: 51 of 108 patients
(95% confidence interval, 37.5%, 57.1%).1,2
61% of responders (31 of 51) reached a duration of response (DoR) of ≥6 months1,2,a,c
Median DoR not reached (range: 1-15.2+ months)1-3,a,c
a At time of data cutoff; based on a combined analysis of Studies 1423 and 1540, which were single-arm, open-label, multicenter, nonrandomized, multicohort studies. Median duration of follow-up was 8.9 months.1 See additional study design details.
b Only includes patients with complete healing of prior cutaneous involvement; locally advanced CSCC patients in Study 1540 required biopsy to confirm CR.1
c Group 2 patients (locally advanced CSCC; cemiplimab-rwlc 3 mg/kg every 2 weeks) who started treatment less than 9 months prior to the data cutoff date and all Group 3 patients (metastatic CSCC; cemiplimab-rwlc 350 mg every 3 weeks) from Study 1540 are excluded from the efficacy analysis set.2