Comparative Efficacy of Cemiplimab to Historical Standard of Care in France

Sanofi305 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

305

Conditions

Cancer/Squamous Cell Carcinoma of Skin

Interventions

CemiplimabDRUG

Pharmaceutical Form: Concentrate solution for injection for intravenous (IV) infusion Route of Administration: Intravenous (IV) infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

France, France

Outcomes

Primary Outcomes

Overall Survival (OS)

The difference OS between treatment and control groups expressed as a Hazard Ratio (HR). OS is the time between treatment initiation and the date of death from any cause. For participants who are alive at data cutoff collection, their survival time will be censored at the last date that they were known to be alive.

Time frame: From patient advanced CSCC diagnosis date up to last medical record available on site or the end of the observation period (July 2022),whichever occurred first

Secondary Outcomes

Progression-Free Surivival (PFS)

Difference in PFS between interventional and control groups expressed as a HR. Defined as the time elapsed from date of first treatment intake to the date of documented recurrent or progressive disease reported by the Investigator or death due to any cause, whichever occurs first. Disease progression will be assessed by tumour response evaluation according to Investigator assessment. Tumour response will be evaluated per routine clinical practice as progressive/not progressive by the physian.

Time frame: From patient advanced CSCC diagnosis date up to last medical record available on site or the end of the observation period (July 2022),whichever occurred first

Duration of Response (DOR)

Defined as the time elapsed between the first reported objective response (complete or partial response) and the first date of recurrent or progressive disease or death due to any cause, whichever occurs first. Tumour response will be evaluated per routine clinical practice by the physician.

Time frame: From patient advanced CSCC diagnosis date up to last medical record available on site or the end of the observation period (July 2022),whichever occurred first

Objective Response Rate (ORR)

Defined as the proportion of participants who achieve partial or complete response from the start of the study treatment. The ORR will be assessed by tumour response evaluation according to Investigator assessment. Tumour response will be evaluated per routine clinical practice by the physician)

Data from ClinicalTrials.gov

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