Advanced CSCC

Up to 5 years of
Long-term
follow-up data

LIBTAYO over time: Continued efficacy demonstrated across data readouts in Study 15401,2*

Response rates over time in patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation1,2

The following data represents 5 years of follow-up for Group 1 and 4 years of follow-up for Group 2 and Group 3. Follow-ups for each group are based on time from primary analysis.1,2

Median duration of follow-up: mCSCC 3 mg/kg Q2W—18.5 months (range, 1.1-41.0); laCSCC 3 mg/kg Q2W— 15.5 months (range, 0.8-43.2);
mCSCC 350 mg Q3W—17.3 months (range, 0.6-43.4).1,2

Long-term follow-up clinical study 1540: response rates in group 1.

Median duration of follow-up: mCSCC 3 mg/kg Q2W—18.5 months (range, 1.1-41.0).1,2

Long-term follow-up clinical study 1540: response rates in group 2.

Median duration of follow-up: laCSCC 3 mg/kg Q2W— 15.5 months (range, 0.8-43.2).1,2

Long-term follow-up clinical study 1540: response rates in group 3.

Median duration of follow-up: mCSCC 350 mg Q3W—17.3 months (range, 0.6-43.4).1,2

Durable responses demonstrated across data readouts1*
Median DOR

Group 1
mCSCC 3 mg/kg
Q2W
(n=59)
Not Reached
(range, 2.8-38.9)
Group 2
laCSCC 3 mg/kg
Q2W
(n=78)
42 months
(range, 1.9-54.6)
Group 3
mCSCC 350 mg/kg
Q3W,
(n=56)
41 months
(range, 4.2-46.3)

LIBTAYO delivered clinically meaningful responses in all cohorts combined1,2

Response rates over time (N=193)1,3,5,6‡

Median duration of follow-up: 15.7 months (range, 0.6-43.2)1,2

Long-term follow-up clinical study 1540: response rates all cohorts combined.

Median duration of follow-up: mCSCC 350 mg Q3W—17.3 months (range, 0.6-43.4).1,2

With each of these data readouts,
LIBTAYO continued to demonstrate
durable responses
in patients with
advanced CSCC1,2

Median DOR1†

41 MONTHS
(range, 1.9-54.6)
  • *Response rates and duration of response are based on analysis by ICR of Study 1540 at time of data cutoff: March 2022.1,8
  • Based on Kaplan-Meier estimate.1
  • Combined median ORR for 2018 is derived from 115 patients in Groups 1 and 3.5
  • CI=confidence interval; CSCC=cutaneous squamous cell carcinoma; DOR=duration of response; ICR=independent central review; laCSCC=locally advanced CSCC; mCSCC=metastatic CSCC; ORR=objective response rate; 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, unacceptable toxicity, or up to 24 months.1