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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Real-world Evidence Study on the Early Use of Cemiplimab in the UK: REACT-CEMI (Real World Evidence of Advanced CSCC Treatment - With CEMIplimab)

Conditions
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Cutaneous Squamous Cell Carcinoma

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients treated with cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation | Other: No intervention<br>* Non-interventional study based on secondary use of hospital medical record<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR within 6 months post initiation of cemiplimab |  | 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. | 6 months, 12 months | 
| Time to best response | The best response to cemiplimab observed during the observation period | 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. | 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. | From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months | 
| 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 | 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 | 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. | 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 | 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. | From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months | 
| Demographics | Age, Sex, Ethnicity | 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) | 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 | 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 | Baseline | 
| Number of cemiplimab infusions |  | 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 |  | 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 |  | From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months | 
| Distribution of cemiplimab dose administered at initiation |  | 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) | 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 |  | From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months | 
| Duration of treatment interruption for patients experiencing irARs |  | 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 |  | 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 |  | From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months |