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Soo Park, MD
Soo Park, MD
Posted: Thursday, June 13, 2024
According to Jason J. Luke, MD, FACP, of the University of Pittsburgh, and colleagues, in the phase III KEYNOTE-716 study of patients with resected stage IIB or IIC melanoma, adjuvant therapy with the immune checkpoint inhibitor pembrolizumab vs a placebo appeared to significantly improve recurrence-free survival at the first interim analysis and distant metastasis–free survival at the third interim analysis. The protocol-specified fourth interim and final analysis of distant metastasis–free survival, which was published in the Journal of Clinical Oncology, supports previous findings.
“Pembrolizumab is the first systemic adjuvant therapy to be approved for use in patients with stage II melanoma, and, to our knowledge, KEYNOTE-716 is the only study with long-term follow-up data available,” the investigators commented.
A total of 976 patients older than age 12 with newly diagnosed cutaneous disease were randomly assigned in a 1:1 ratio to receive 200 mg (2 mg/kg up to 200 mg in pediatric patients) of intravenous pembrolizumab or a placebo once every 3 weeks for 17 cycles or until disease recurrence, unacceptable toxicity, or withdrawal of consent. As of January 2023, follow-up data were provided for a median of 39.4 months.
The median duration of distant metastasis–free survival was not reached with pembrolizumab nor with the placebo; the estimated 36-month rates were 84.4% and 74.7%, respectively (hazard ratio [HR] = 0.59). Likewise, neither arm reached the median duration of recurrence-free survival, with an estimated 36-month rate of 76.2% with pembrolizumab and 63.4% with the placebo (HR = 0.62). The investigators noted consistent distant metastasis–free and recurrence-free survival outcomes across most prespecified subgroups, including patients with stage IIB disease and those with stage IIC disease. The investigators observed a manageable safety profile with the use of pembrolizumab, which was consistent with previous reports.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
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