In this study, patients whose squamous cell skin cancer had come back or spread, and for whom surgery or radiotherapy was not possible, received the immunotherapy drug pembrolizumab every 3 weeks. The tumour shrank in about 1 in every 3 patients, and in many of them the effect lasted. In patients whose cancer had grown only in the same area, almost half responded. Serious side effects were uncommon.
Recurrent or metastatic cSCC, or locally advanced cSCC not curable by surgery or radiotherapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Pembrolizumab | 200 mg (or 400 mg) | IV, 30-minute infusion | Day 1 every 3 weeks (400 mg dose: every 6 weeks) |
Per the FDA label; evidence:.
Recurrent or metastatic cutaneous SCC, or locally advanced disease not curable with surgery or radiotherapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Pembrolizumab | 200 mg (or 400 mg) | IV infusion over 30 minutes | 200 mg every 3 weeks or 400 mg every 6 weeks |
Per the FDA label. Evidence:. The trial excluded patients with autoimmune disease or needing immunosuppression.
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.
Pembrolizumab 200 mg IV every 3 weeks until documented disease progression, unacceptable toxicity or a maximum of 24 months (up to 35 cycles). With initial radiographic progression, treatment could continue until progression was confirmed, unless progression was symptomatic or rapid or required urgent intervention. Tumour assessment every 6 weeks in year 1 and every 9 weeks in year 2.
Source of the regimen details: Abstract and full text of the paper (J Clin Oncol 2020), abstract of Ann Oncol 2021 (up to 35 cycles) and the FDA label for Keytruda (section 14.19)
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.
Adults aged 18 or older with histologically confirmed cutaneous squamous cell carcinoma (cSCC), measurable disease by RECIST 1.1 (or assessable by digital photography), ECOG 0 or 1, adequate tissue for PD-L1 testing and life expectancy of more than 3 months. Recurrent or metastatic cohort: locoregional recurrence not curable by surgery or radiotherapy and/or metastatic disease. Patients with autoimmune disease or a condition requiring immunosuppression were excluded. Median age 72 years (29 to 95); ECOG 1 in 65.7% and stage IV in 82.9%. According to the FDA label, 87% had received at least one prior line of therapy and 73% prior radiotherapy.
Primary endpoint: objective response rate by RECIST 1.1 on independent central review. Secondary endpoints: duration of response, disease control rate, progression-free survival, overall survival and safety.
Treatment-related adverse events occurred in 66.7% (most common: pruritus 14.3%, asthenia 13.3% and fatigue 12.4%); treatment-related grade 3 to 5 events in 5.7% and treatment-related serious events in 6.7%. Immune-mediated adverse events occurred in 21.9% (hypothyroidism 9.5%, severe skin reactions 4.8%, pneumonitis 3.8%, adrenal insufficiency 2.9% and hyperthyroidism 2.9%), with no grade 4 or 5 immune-mediated events. Discontinuation because of adverse events in 12.4%. One treatment-related death (cranial nerve neuropathy). Across all 159 patients, treatment-related grade 3 to 5 events occurred in 11.9% (Ann Oncol 2021).
The basis of FDA approval of pembrolizumab in recurrent or metastatic cSCC and in locally advanced cSCC not curable by surgery or radiotherapy, at 200 mg every 3 weeks or 400 mg every 6 weeks for up to 24 months. The 2026 EADO guideline considers anti-PD-1 agents the first-line systemic treatment for metastatic or locally advanced cSCC. Adjuvant pembrolizumab (KEYNOTE-630) did not meet its primary endpoint.
Single-arm, non-randomised trial without a comparator; the first report was an interim analysis with short follow-up. Patients requiring immunosuppression (including organ transplant recipients) and patients with ECOG 2 or more were not enrolled. The PD-L1 analysis was exploratory and the CPS below 1 group was very small.
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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