Real World Study on the Use of Cemiplimab in Adult Patients in UK

Sanofi110 enrolled

Overview

The primary objective is to describe the real-world clinical effectiveness of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) or metastatic cutaneous squamous cell carcinoma (mCSCC) treated in routine clinical practice.

Patients initiating treatment with cemiplimab in the UK between 2nd July 2019 and 30th November 2020, will be followed for a minimum of 12 and a maximum of 36 months from initiation of cemiplimab.

Study Type

OBSERVATIONAL

Enrollment

110

Conditions

Cutaneous Squamous Cell Carcinoma

Interventions

No interventionOTHER

Non-interventional study based on secondary use of hospital medical record

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged \>=18 years at initiation of cemiplimab. * Patients treated with \>=1 dose of cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation according to routine practice. * Patients initiating treatment with cemiplimab in the UK between 2nd July 2019 and 30th November 2020. Exclusion Criteria: * Patients who are known to have opted out of participation in any research (as required for compliance with GDPR). * Patients participating in any form of investigative study (e.g., clinical trials) during the post-index observation period.

Locations (1)

Sanofi-Aventis UK

Reading, Berkshire, United Kingdom

Outcomes

Primary Outcomes

Overall response rate (ORR) within 12 months post initiation of cemiplimab

ORR, defined as the proportion of patients who have a partial or complete response to cemiplimab based on an assessment according to routine practice, as documented in medical records

Time frame: 12 months

Secondary Outcomes

ORR within 6 months post initiation of cemiplimab

Time frame: 6 months

Real-world best response within 6- and 12-months post initiation of cemiplimab

Real-world best response, defined as the best response to cemiplimab observed during the observation period.

Time frame: 6 months, 12 months

Time to best response

The best response to cemiplimab observed during the observation period

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Time to partial response

Time to partial response, defined as time from cemiplimab initiation until the first documentation of a partial response based on assessment according to routine practice, as documented in medical records.

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Time to complete response

Time to complete response, defined as time from cemiplimab initiation until the first documentation of a complete response based on assessment according to routine practice, as documented in medical records.

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Data from ClinicalTrials.gov

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Disease control rate (DCR) within 6 and 12 months post initiation of cemiplimab

DCR, defined as the proportion of patients who have a complete response, partial response or stable disease based on an assessment according to routine practice, as documented in medical records

Time frame: 6 months, 12 months

Duration of response (DoR)

DoR, defined as the time from the first documentation of a complete or partial response to cemiplimab in medical records until first documentation of disease progression or death

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Duration of treatment (DoT)

DoT, defined as the time from cemiplimab initiation to the documented date of treatment discontinuation.

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Real-world progression-free survival (rwPFS)

rwPFS, defined as the time from cemiplimab initiation to date of disease progression or death as recorded in the medical records

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Overall survival (OS)

OS, defined as the time from cemiplimab initiation to date of death from any cause.

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Demographics

Age, Sex, Ethnicity

Time frame: Baseline

Medical history

Co-morbidities, Eastern Cooperative Oncology Group performance status, Stage of disease, Primary CSCC lesion disease site and date diagnosed (where available), Time from diagnosis of primary disease to diagnosis of laCSCC or mCSCC not suitable for curative surgery or curative radiotherapy (where available)

Time frame: Baseline

Previous treatments

Previous treatments for cemiplimab index CSCC lesion(s) during the pre-index observation period, Previous treatments for cemiplimab non-index CSCC lesion(s) during the pre-index observation period, Previous treatments for any prior skin malignancies during the pre-index observation period

Time frame: Baseline

Clinical characteristics outcome

Proportion of patients treated with antibiotics in the 6 wks prior to or 6 wks post-initiation of cemiplimab, Proportion of patients with immunocompromised status and treatment history incl. any concomitant therapy, Proportion of patients with a history of organ transplantation, Frequency and distribution of prior organ transplantations by type, Frequency and distribution of prior malignancies overall and by type, Type of Multidisciplinary team review and referral prior to laCSCC/mCSCC diagnosis

Time frame: Baseline

Number of cemiplimab infusions

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Proportion of patients where cemiplimab treatment was interrupted, overall and by reason for interruption

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Proportion of patients permanently discontinuing treatment, overall and by reason for discontinuation

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Distribution of cemiplimab dose administered at initiation

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Proportion of patients experiencing immune-related adverse reactions (irARs) of any grade (where reported in notes)

irAR, defined as treatment-related, immune-related adverse events (as defined by local investigator)

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Proportion of patients with cemiplimab treatment interruptions due to experiencing irARs

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Duration of treatment interruption for patients experiencing irARs

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Proportion of patients treated with anti-inflammatory drugs (e.g., steroids) for irARs, overall and by type of irAR

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months

Initial dose of anti-inflammatory drug (e.g., steroids) used to treat irARs at onset of irARs and for the duration of irARs by steroid type

Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months