Median time to response was rapid (1.9 months; range 1.7 to 9.1 months), based on an open-label, single-arm trial that did not include comparisons to other treatments (first assessment was performed at 8 weeks)
46% ORR (63 out of 137 patients;
95% CI: 37%, 55%)
31% PR (42 out of 137 patients)†;
15% CR (21 out of 137 patients [95% CI: 9%, 22%])‡
79% of responders (50 out of 63 patients) reached
a DOR of ≥6 months1,2,*
54% of responders (34 out of 63 patients) reached
a DOR of ≥12 months1,2,*
Median DoR was not reached
(range: 1.9–24.2+ months)1-3
In an additional cohort in Study 1540, 56 mCSCC patients received LIBTAYO at a dose of 350 mg intravenously every 3 weeks for up to 54 weeks. With a median duration of follow-up of 8.0 months, the confirmed ORR was 41% (95% CI: 28, 55), and 65% of responders had a DOR ≥6 months.1
Among 26 CSCC patients in Study 1423, 16 had mCSCC and 10 had laCSCC. One patient in the mCSCC group was dosed at 1 mg/kg every 2 weeks. The rest received 3 mg/kg every 2 weeks. With a median duration of follow-up of 13.3 months, the confirmed ORR was 50% (95% CI: 30, 70); all responses were PRs. The median time to response was 1.9 months (range: 1.7–7.3 months), and 85% of responders had a DOR ≥6 months.1
The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.1