Primary Objective:

-Assess the effectiveness of cemiplimab versus other available systemic therapies in patients up to 2018 or say historical system organ class (SOC) with metastatic or locally advanced cutaneous Squamous Cell Carcinoma (CSCC) who are not candidates for curative surgery or curative radiation, on overall survival (OS).

Secondary Objectives:

• Assess Progression Free Survival (PFS)
• To assess Duration of Response (DOR)
• To assess Objective Response Rate (ORR)
• To describe adverse events leading to treatment interruptions and deaths

Study duration is approximately 9 months. For the Standard of Care Arm, data of the subjects evaluated between 01 Aug 2013 and 01 Aug 2018 was observed. For the Cemiplimab arm, data of the subjects evaluated between Aug 2018 and October 2019 was observed.

Inclusion Criteria:

All patients:

• Adult 18 years of age or older

• With an unresectable locally advanced CSCC (who are not candidates for curative surgery or curative radiation therapy) or metastatic CSCC (nodal or distant)

• Subject alive at start data collection who has received information note and has not opposed to data collection OR

  • Subject who died before study initiation and who has not opposed to data collection for research purpose when he/she was alive

Treatment Group:

• Patient treated by cemiplimab in monotherapy through the cATU or patient included in the nATU that evolved into the cATU.
• With an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at the time of cemiplimab initiation

Control Group:

• Patient treated by any systemic treatment initiated until August 1st , 2018 included
• With an ECOG score of 0 or 1 at the time of treatment initiation for at least one line of systemic therapy initiated from August 1st 2013 to August 1st 2018. The related treatment line must be among the 3 first systemic treatment lines for patients having initiated more than 3 lines.

Exclusion Criteria:

All patients:

- Patient treated by another anti- Programmed Cell Death Receptor-1 (PD1)

Control group:

-Patient subsequently treated with cemiplimab

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

The source population for this study will be adult patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or curative radiation and who received cemiplimab in monotherapy through the cATU or patient included in the nATU that evolved into the cATU (treatment group) and patients who initiated a systemic therapy as 1st, 2nd or 3rd line of treatment before the start of the cemiplimab nATU, i.e. initiated from August 1st 2013 to August 1st 2018 (control group) recruited from particpating sites in France. The study will aim to enroll approximately 250 patients in the cemiplimab group and 625 patients in the control group from up to 34 sites which included at least 4 patients in the cohort temporary authorization of use.

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org