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 Complete response is defined as disappearance of all target lesions for at least 4 weeks. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm (<1 cm). Only includes patients with complete healing of prior cutaneous involvement; locally advanced CSCC patients in Study 1540 required biopsy to confirm CR.1,2
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
NCCN Guidelines® recommend cemiplimab-rwlc (LIBTAYO), an immune checkpoint inhibitor, as the only preferred systemic therapy option for appropriate patients with4:
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