One year of immunotherapy with pembrolizumab after surgery for stage III melanoma was still lowering the risk of the disease coming back after about 7 years of follow-up: half of the patients in the pembrolizumab group were free of recurrence, compared with 36% in the placebo group.
Stage IIB, IIC or III melanoma after complete resection (adults and children aged 12 years and older)
| 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; children aged 12 years and older: 2 mg/kg every 3 weeks (maximum 200 mg). Evidence:.
On the page “Melanoma (skin cancer)” · Resectable melanoma: neoadjuvant and adjuvant
High-risk resected melanoma
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Pembrolizumab | 200 mg (or 400 every 6 weeks) | IV | Every 3 weeks |
As in KEYNOTE-054.
Dose source:.
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 on day 1 of each 21-day cycle, 18 doses in total (about 1 year) or until recurrence or unacceptable toxicity (514 patients). In part 2, patients with recurrence could receive pembrolizumab every 3 weeks for up to 2 years or until further progression.
Placebo (saline) IV on day 1 of each 21-day cycle for up to 18 doses (505 patients); patients with recurrence could receive pembrolizumab for up to 2 years in part 2.
Source of the regimen details: Abstract of the paper, abstract of the original report (NEJM 2018) and ClinicalTrials.gov NCT02362594
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 with completely resected high-risk stage III melanoma (excluding mucosal or ocular melanoma), with ECOG 0 or 1, tumour tissue available for PD-L1 assessment and no prior melanoma treatment other than surgery (or interferon for a thick primary melanoma without lymph node involvement); patients with active autoimmune disease, a history of pneumonitis requiring steroids or use of immunosuppressants were excluded. Stratification by stage and geographical region (ClinicalTrials.gov NCT02362594).
Co-primary endpoints: recurrence-free survival in the overall population and in the PD-L1-positive subgroup; secondary: distant metastasis-free survival; exploratory: progression/recurrence-free survival 2 (PRFS2).
Safety data are not reported in the abstract of this analysis. In the original report (NEJM 2018), treatment-related grade 3 to 5 adverse events occurred in 14.7% of pembrolizumab patients and 3.4% of placebo patients, and one treatment-related death (myositis) was reported in the pembrolizumab group.
Confirms the durability of the benefit of adjuvant pembrolizumab in stage III disease; the ESMO 2025 guideline recommends adjuvant anti-PD-1 therapy at level I, A and notes that mature overall survival data versus placebo are lacking.
Overall survival is not reported in the abstract; PRFS2 is an exploratory endpoint.
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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