Advanced CSCC

Efficacy Overview

In patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation:

Efficacy in Study 1540 (N=137): patients who received LIBTAYO 3 mg/kg Q2W1*

46% ORR

(95% CI, 37%-55%)1
31%
partial response (PR)§
15%
complete
response (CR)||

Median TTR was 1.9 months (range, 1.7-9.1 months)1

79%

of responders

(50 out of 63)
reached a DOR
≥6 months1†

54%

of responders

(34 out of 63)
reached a DOR
≥12 months1†

  • Median DOR was not reached (range, 1.9-24.2+ months)1†

Efficacy in an additional cohort of Study 1540: mCSCC patients who received LIBTAYO 350 mg Q3W (n=56)1*

  • ORR was 41% (23 out of 56 patients [95% CI, 28%-55%])1†
  • 65% of responders (15 out of 23) reached a DOR of ≥6 months1
  • Median DOR was not reached (range, 2.1-11.1+)

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

  • Plus sign (+) denotes ongoing at last assessment.1
  • *Data cutoff was September/October 2018.2
  • Median duration of follow-up was 11.1 months and 8.0 months in patients who received LIBTAYO 3 mg/kg Q2W and LIBTAYO 350 mg Q3W in Study 1540, respectively.1
  • PR is defined as a decrease of ≥30% in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, per RECIST 1.1. PR of externally visible disease is defined as a decrease of ≥50% in the sum of products of perpendicular longest dimensions of target lesions, per WHO criteria. Nontarget lesions could not have progressive disease and there could be no new lesions. Responses had to be maintained for at least 4 weeks.1,2
  • §CR is defined as disappearance of all target lesions for at least 4 weeks. Nontarget lesions also had to show a CR and there could be no new lesions. Any pathological lymph nodes (whether target or nontarget) must have shown a reduction in short axis to <10 mm (<1 cm). Only includes patients with complete healing of prior cutaneous involvement; patients with laCSCC in Study 1540 required biopsy to confirm a CR.1,2

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)3

NCCN Guidelines® for Squamous Cell Skin Cancer V2.2022 recommend cemiplimab-rwlc (LIBTAYO®) as a preferred systemic therapy option for appropriate patients with advanced CSCC3||

Category 2A,|| preferred recommendation3

Locally advanced CSCC

When curative surgery and curative radiation therapy are not feasible

A preferred PD-1 inhibitor

Regional CSCC

When curative surgery and curative radiation therapy are not feasible

A preferred PD-1 inhibitor

Distant metastatic CSCC or regionally recurrent CSCC

When curative surgery and curative radiation therapy are not feasible

A preferred PD-1 inhibitor

  • ||Category 2A recommendation is based upon lower-level evidence; there is uniform NCCN® consensus that the intervention is appropriate. All recommendations are Category 2A unless otherwise specified.
  • For patients who have complicated cases of locally advanced disease in which curative surgery and curative radiation therapy are not feasible. Assessment of feasibility of radiation therapy should be made by a radiation oncologist.

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.

  • CSCC=cutaneous squamous cell carcinoma; DOR=duration of response; laCSCC=locally advanced CSCC; mCSCC=metastatic CSCC; NCCN®=National Comprehensive Cancer Network®; ORR=objective response rate; Q2W=every 2 weeks; Q3W=every 3 weeks; RECIST=Response Evaluation Criteria in Solid Tumors; TTR=time to response; WHO=World Health Organization.