Some people with squamous-cell skin cancer have a high chance of the cancer coming back, even after surgery and radiotherapy. In this study, receiving the immunotherapy drug cemiplimab after these local treatments greatly lowered the chance of the cancer returning or of death, compared with a placebo (dummy treatment). On the other hand, serious side effects were more common with cemiplimab, and more patients stopped treatment because of side effects. Decisions about this treatment should be made with your own doctor, weighing the risk of the cancer returning against possible side effects.
cSCC at high risk of recurrence after surgery and radiotherapy; decision by a multidisciplinary team
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Part 1 | |||
| Cemiplimab | 350 mg | IV, 30-minute infusion | Every 3 weeks for 12 weeks |
| Part 2 | |||
| Cemiplimab | 700 mg (or continue 350 mg every 3 weeks) | IV, 30-minute infusion | Every 6 weeks |
Per the FDA label; evidence:.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Cemiplimab 350 mg as a 30-minute IV infusion every 3 weeks for 12 weeks, then 700 mg every 6 weeks for 36 weeks (a maximum of 48 weeks in total), or until recurrence or unacceptable toxicity. The FDA label also allows continuing 350 mg every 3 weeks as an alternative.
IV placebo (30-minute infusion) every 3 weeks for 12 weeks, then every 6 weeks for up to 36 weeks (a maximum of 48 weeks in total).
Source of the regimen details: Abstract of the paper (dose and schedule for both groups), ClinicalTrials.gov NCT03969004 (30-minute infusion) and the FDA label (LIBTAYO)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with locally or regionally advanced cutaneous squamous-cell carcinoma at high risk of recurrence because of nodal or non-nodal features after surgery and postoperative radiotherapy. Other criteria: macroscopic resection of all lesions, completion of curative-intent postoperative radiotherapy 2 to 10 weeks before randomisation, ECOG 0 or 1 and adequate hepatic, renal and bone marrow function; non-cutaneous SCC, a history of distant metastases (unless disease-free for at least 3 years) and significant autoimmune disease were excluded (ClinicalTrials.gov).
Primary endpoint: disease-free survival.
Secondary endpoints: freedom from locoregional recurrence, freedom from distant recurrence, and safety.
Grade 3 or higher adverse events occurred in 23.9% of patients receiving cemiplimab and 14.2% of those receiving placebo. Treatment was discontinued because of adverse events in 9.8% and 1.5% of patients, respectively.
This phase 3 trial showed that adjuvant cemiplimab after surgery and radiotherapy improves disease-free survival over placebo in high-risk cutaneous squamous-cell carcinoma and lowers the risk of locoregional and distant recurrence. These results support adjuvant immunotherapy in this high-risk group. The status of regulatory approvals and formal clinical guideline recommendations should be checked separately, as the abstract does not address them.
Median follow-up was 24 months, so longer-term data and overall survival results are not reported in the abstract. The higher rates of grade 3 or higher adverse events and of treatment discontinuation with cemiplimab must be considered in patient selection. Further details on subgroups and immune-mediated adverse events are in the full paper.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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