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Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma (KEYNOTE-716): distant
Georgina V Long1, Jason J Luke2, Muhammad A Khattak3
1Melanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore & Mater Hospitals, Sydney, NSW, Australia.
The Lancet. Oncology
|October 20, 2022
Summary
Adjuvant pembrolizumab significantly reduced distant metastasis and recurrence risk in patients with stage IIB or IIC melanoma. This immunotherapy offers a positive benefit-risk profile for resected melanoma patients.
Area of Science:
- Oncology
- Immunotherapy
- Melanoma Research
Background:
- Stage IIB/IIC melanoma patients face high recurrence risk after surgery.
- Adjuvant pembrolizumab demonstrated improved recurrence-free survival in prior analyses.
- This study reports on distant metastasis-free survival and longer-term recurrence-free survival.
Purpose of the Study:
- To evaluate adjuvant pembrolizumab's efficacy in preventing distant metastasis and recurrence.
- To report findings from the third interim analysis of the KEYNOTE-716 trial.
- To assess the long-term benefit-risk profile of pembrolizumab in resected melanoma.
Main Methods:
- Phase 3, double-blind, placebo-controlled trial (KEYNOTE-716) in 160 centers.
- 976 patients with resected stage IIB/IIC melanoma randomly assigned to pembrolizumab or placebo.
- Primary endpoint: recurrence-free survival; secondary endpoint: distant metastasis-free survival.
Main Results:
- Pembrolizumab significantly improved distant metastasis-free survival (HR 0.64, p=0.0029).
- Recurrence risk was lower with pembrolizumab (HR 0.64).
- Adverse event profile was consistent with prior pembrolizumab studies; no treatment-related deaths.
Conclusions:
- Adjuvant pembrolizumab is an effective treatment for resected stage IIB/IIC melanoma.
- Significant improvements in distant metastasis-free survival and sustained reduction in recurrence risk observed.
- Pembrolizumab maintains a positive benefit-risk profile in the adjuvant setting.
