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KEYNOTE-716: adjuvant therapy with pembrolizumab for patients with high-risk stage II melanoma

Omid Hamid, MD, The Angeles Clinic and Research Institute, Los Angeles, CA, discusses the design and the findings from the randomized double-blind Phase III KEYNOTE-716 study (NCT03553836) evaluating the safety and efficacy of pembrolizumab compared to placebo in resected high-risk stage II melanoma, which is a group of patients at a high risk of recurrent disease. In this study, patients with disease recurrence were unblinded and initiated pembrolizumab treatment if they were previously in the placebo arm. At 12 months, there was a statistically significant improvement in recurrence-free survival (Hazard Ratio (HR): 0.65). There was also a significant benefit in distant metastasis-free survival for patients in the pembrolizumab arm. Dr Hamid explains that it is essential to find biomarkers identifying the patients that will benefit from pembrolizumab therapy since it is also associated with important side effects. Several clinical trials are looking at circulating tumor DNA (ctDNA), tumor mutational burden, and IFNγ signature as potential biomarkers. This interview took place at the European Society for Medical Oncology (ESMO) 2021 congress.