Free age progression skin#Of those pembrolizumab patients who had disease recurrence, 31 (6.4%) had skin and/or local regional recurrence versus 41 (8.4%) of patients on placebo. In addition, 54 patients (11.1%) on pembrolizumab had a recurrence compared with 82 patients (16.8%) on placebo. RFS plotted over time with Kaplan-Meier analysis, showed that at 6 months the curves began to separate, resulting in RFS rates of 90.5% for pembrolizumab-treated patients at 12 months versus 83.1% in patients receiving the placebo, Luke reported, and "this was highly statistically significant, with the hazard ratio of 0.65." Prespecified subgroups were comparably matched in terms of age, sex, T-category, and disease stage. And thoughts about where melanoma therapeutics, and earlier therapy, takes us in other solid tumors that are just coming to the adjuvant PD-1 paradigm." "And then questions about how we treat on relapse, and how we treat in the metastatic setting, having exhausted single-agent PD-1. "With a proposed approval, we will have a lot more patients in an earlier time to treat," he said. "And all of this data suggests that adjuvant pembrolizumab is an effective treatment option with a favorable benefit/risk profile for patients with high-risk stage II melanoma," he stated.īut the study leaves oncologists with many unanswered questions, according to ESMO discussant Omid Hamid, MD, of the Angeles Clinic and Research Institute in Los Angeles. In addition, there were fewer cases of distant recurrences in patients in the pembrolizumab arm compared with placebo, with a safety profile that was consistent with previous clinical trials, said Luke in a presentation at the European Society for Medical Oncology (ESMO) virtual meeting.
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