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

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

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

The best response to cemiplimab observed during the observation period

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 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.

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

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

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

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

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

Age, Sex, Ethnicity

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)

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

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

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