Advanced CSCC

Study Design Studies 1423 and 1540

LIBTAYO was validated in the largest prospective clinical trial program for
advanced CSCC1-10

mCSCC or laCSCC who are not candidates for curative surgery or curative radiation

Study 1423 trial design: advanced CSCC cohorts (N=26)1
mCSCC

Patients with mCSCC (nodal
or distant)
(n=16)

laCSCC

Patients with laCSCC who were
not candidates for curative
surgery or curative radiation
(n=10)

LIBTAYO
3 mg/kg Q2W for
up to 48 weeks*
Tumor response
assessment
every
8 weeks
  • *One patient in the mCSCC group was dosed at 1 mg/kg.

Study 1423 was an open-label, multicenter, nonrandomized, multicohort study that included 26 patients with mCSCC (n=16) or laCSCC (n=10) who were not candidates for curative surgery or curative radiation. Patients received LIBTAYO 3 mg/kg intravenously every 2 weeks for up to 48 weeks. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment.1

Study 1423 excluded patients with autoimmune disease who required systemic therapy with immunosuppressant agents within 5 years; history of solid organ transplant; prior treatment with anti–PD-1/PD-L1–blocking antibodies or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B, or hepatitis C; or ECOG PS ≥2.1

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

Efficacy endpoints in patients with advanced CSCC in
Study 14231*:

  • ORR was 50% (13 out of 26 patients [95% CI, 30%-70%]); all responses were PRs
  • Median time to response was 1.9 months (range, 1.7-7.3 months)
  • 85% of responders (11 out of 13) reached a DOR ≥6 months
In this trial, DOR range was 1.0 to 20.3 months.13
  • *Data cutoff date was April 30, 2019. Median duration of follow-up was 13.3 months.1,13

Study 1540 trial design (N=193)1
mCSCC

Group 1Patients with mCSCC (nodal or
distant) (n=59)

laCSCC

Group 2 Patients with laCSCC who were
not candidates for curative
surgery or curative radiation
(n=78)

LIBTAYO
3 mg/kg Q2W for
up to 96 weeks
Tumor response
assessment
every
8 weeks
mCSCC

Group 3 Patients with mCSCC (nodal or
distant)
(n=56)

LIBTAYO
350 mg Q3W
for up to 54 weeks
Tumor response
assessment
every
9 weeks

Study 1540: EMPOWER-CSCC 1 was a global, pivotal, open-label, nonrandomized, multicohort study that included 193 patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation (targeted enrollment). Patients received LIBTAYO 3 mg/kg intravenously every 2 weeks for up to 96 weeks or LIBTAYO 350 mg every 3 weeks for up to 54 weeks. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment.1

Study 1540 excluded patients with autoimmune disease who required systemic therapy with immunosuppressant agents within 5 years; history of solid organ transplant; prior treatment with anti–PD-1/PD-L1–blocking antibodies or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B, or hepatitis C; or ECOG PS ≥2.1

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
  • CR=complete response; CSCC=cutaneous squamous cell carcinoma; DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; ICR=independent central review;
    laCSCC=locally advanced CSCC; mCSCC=metastatic CSCC; ORR=objective response rate; PD-1=programmed death receptor-1; PD-L1=programmed death ligand 1; PR=partial response; PS=performance status; Q2W=every 2 weeks; Q3W=every 3 weeks.