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Updated: Dec 11, 2025
A Melanoma Patient-Derived Xenograft Model
Published on: May 20, 2019
Safety of pembrolizumab for resected stage III melanoma
1Service de Dermatologie, ImmuCare, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon , Pierre-Bénite, France.
Introduction:
Patients with resected stage III melanoma have a heterogeneous prognosis with an especially high risk of relapse for patients with stage IIIB, IIIC and IIID according to the 2018 classification in AJCC Cancer Staging Manual, 8th edition (AJCC-8). Ipilimumab was the first immune checkpoint inhibitor (ICI) to show prolonged overall survival (OS) but at the cost of high toxicity. Pembrolizumab and nivolumab are inhibitors of programmed cell death 1 (PD-1) and showed prolonged relapse-free survival (RFS) in patients with resected stage III melanoma at high risk of relapse compared to placebo and ipilimumab, respectively.
Areas Covered:
The aim of this article is to review the mechanisms of action, pharmacokinetics and safety data of pembrolizumab in resected stage III melanoma and to compare its safety profile to other immune checkpoint inhibitors for the same indication.
Expert Opinion:
Pembrolizumab as adjuvant therapy of resected stage III melanoma showed an acceptable safety profile, which is comparable to that in advanced melanoma. However, it caused one death. There is uncertainty about its benefits in AJCC-8 stage IIIA melanoma patients. Additionally, caution is required since OS and long-term safety data are not available yet.
Insights
Pembrolizumab shows an acceptable safety profile for resected stage III melanoma adjuvant therapy. However, long-term data and benefits for stage IIIA melanoma patients require further investigation.
Area of Science:
- Oncology
- Immunology
- Pharmacology
Background:
- Resected stage III melanoma presents a heterogeneous prognosis, with high relapse risk in stages IIIB-IIID (AJCC-8).
- Immune checkpoint inhibitors (ICIs) like ipilimumab, pembrolizumab, and nivolumab offer improved survival outcomes.
- PD-1 inhibitors demonstrate prolonged relapse-free survival in high-risk stage III melanoma.
Purpose of the Study:
- Review pembrolizumab's mechanism, pharmacokinetics, and safety in resected stage III melanoma.
- Compare pembrolizumab's safety profile against other ICIs for this indication.
Main Methods:
- Literature review of clinical trial data and safety profiles.
- Analysis of pembrolizumab's efficacy and tolerability in adjuvant therapy.
Main Results:
- Pembrolizumab demonstrates an acceptable safety profile in adjuvant therapy for resected stage III melanoma.
- Its safety is comparable to that observed in advanced melanoma, though one death was reported.
- Efficacy and long-term safety data, particularly for stage IIIA melanoma, remain uncertain.
Conclusions:
- Pembrolizumab offers a potentially favorable safety profile as adjuvant therapy for resected stage III melanoma.
- Further data are needed to confirm benefits in AJCC-8 stage IIIA patients and assess long-term outcomes.
- Caution is advised due to the lack of comprehensive overall survival and long-term safety data.
