KEY TAKEAWAYS
- The REACT-CEMI, a UK non-interventional study analyzed key demographics, response rates, and safety events of CEMIplimab for aCSCC pts.
- The study collected data from 105 adult patients treated with cemiplimab for aCSCC (02/07/2019 – 30/11/2020) at 10 cancer centers.
- The overall response rate was 42% within 12 months, with a median response duration of 22.3 months.
- About 19% of patients experienced immune-related adverse reactions, leading to treatment interruptions in 6% of cases.
- New data on cemiplimab for aCSCC pts in the UK align with previous trial outcomes, providing essential guidance for treatment decisions.
This UK REACT-CEMI study collected data from medical records at 10 cancer centers in 105 adult patients (pts) who had received more than one dose of cemiplimab for advanced cutaneous squamous cell carcinoma (aCSCC). Researchers analyzed the patient records for up to 36 months. Out of 105, 70% of the pts were male. As for disease classification, 31% of pts presented with locally advanced disease, while 61% had metastatic disease. Most patients, accounting for 69%, had received previous treatment. The median age at index was reported at 78.6 years, ranging from 55.5-93.3 years. Out of the cohort, 80 pts underwent ECOG performance status assessments, with 89% rated PS 0-1 and 11% rated PS >2.
As per the study, 17% of the pts were immunocompromised, and one had a history of organ transplant. The primary endpoint of the study was the overall response rate (ORR) 12 months after starting cemiplimab, which was found to be 42% with a confidence interval of 95% ranging from 32% to 51%. The ORR was 45% (95% CI: 35%-54%), with 15% of the patients achieving a complete response. The median time to the best response was about 3.5 months (range: 0.7-23.0 months). The median duration of response was 22.3 months (range: 0.7-34.3 months). The disease control rate within 12 months was estimated to be 62%. According to the data, 19% of pts experienced grade immune-related adverse reactions (irARs), which prompted treatment interruptions in 6% of patients. At the time of data cut-off, 84% of pts had discontinued treatment.
These findings offered valuable insights into the clinical effectiveness and safety of cemiplimab in the UK for aCSCC patients, including those typically excluded from clinical trials. The results align with those reported in the EMPOWER-CSCC-1 study and add to the existing evidence, which can help guide treatment decisions for aCSCC.
Source: https://eado2023.com/wp-content/uploads/2023/04/Abstract-Band_EADO2023_Stand-21-04-2023-kl.pdf
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05493826
Dr Amar Challapalli1, Dr Grant Stewart2, Mr Peter John Davies3, Dr Juan Carlos Lopez-Baez3, Dr Amarnath Challapalli3, Dr Heather Shaw4,5 1 Bristol Haematology and Oncology Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Upper Maudlin Street, Bristol BS2 8ED, United Kingdom / 2 Royal Cornwall Hospital, Treliske, Truro TR1 3LJ, United Kingdom / 3 Sanofi, 410 Thames Valley Park Drive, Reading, RG6 1PT, United Kingdom / 4 University College London Hospital, Euston Road, London NW1 2PG, United Kingdom / 5 Mount Vernon Cancer Centre, Rickmansworth Road, Northwood HA6 2RN, United Kingdom
