According to a recent report in the Journal of Clinical Oncology, over one thousand patients with high-risk stage III melanoma were included in the Keynote-054 clinical trial (NCT02362594). The patients, who had undergone lymph node removal (dissection) received either pembrolizumab at a flat dose of 200mg (n-514) as add-on therapy, or a placebo (n505).
The dosing was to continue for one year at three-week intervals until the disease returned or the patient experienced severe toxicity.
The researchers’ goal was to determine whether treatment with pembrolizumab for one year will result in Recurrence Free Survival in a majority of patients as well as patients with PD-L1 (programmed ligand) positive tumors.
At the fifteen-month interval, 351 patients showed recurrence-free survival prompting approval of pembrolizumab by the USFDA and the European Medicines Agency.
The Three Year Follow-Up
The Journal is now reporting the results of a three-year follow-up. It reports that the recurrence-free survival rate at this point was significant (64%) in the pembrolizumab cohort compared to patients given a placebo (44%).
And in Conclusion . . .
Investigators reported that Pembrolizumab provided a twenty percent improvement in the Recurrence Free Survival rate for high-risk resected melanoma patients when compared to a placebo. The drug was tolerable and the drug’s safety rating remained consistent for all subgroups.
