(n = 59), %
Locally advanced CSCC
(n = 78), %
(N = 137), %
|Complete response, CR||17||13||15|
|Partial response, PR||32||31||31|
|Objective response rate,
ORR (CR + PR)
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 data cutoffs for the above results were September/October 2018 for Study 1540 and June 2018 for Study 1423.
laCSCC, locally advanced cutaneous squamous cell carcinoma; mCSCC, metastatic cutaneous squamous cell carcinoma; Q2W, every 2 weeks; Q3W, every 3 weeks.
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
LIBTAYO is 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 radiation.