Merck (NJ, USA) (known as MSD outside the United States and Canada) and the European Organisation for Research and Treatment of Cancer (EORTC) have announced findings from their Phase III KEYNOTE-054 trial.
In this trial, KEYTRUDA® (pembrolizumab) significantly prolonged recurrence-free survival (RFS), reducing the risk of disease recurrence by 43% compared with placebo as an adjuvant therapy in resected, high-risk stage III melanoma patients.
The findings were presented at the American Association for Cancer Research (AACR) Annual Meeting 2018 (April 14–18, IL, USA) and published simultaneously in The New England Journal of Medicine.
KEYTRUDA is the first anti-PD-1 therapy to demonstrate RFS benefit across stage IIIA (> 1 mm lymph node metastasis), IIIB and IIIC melanoma. The RFS benefit was also seen regardless of BRAF mutation status. The safety profile of KEYTRUDA was consistent with what has been seen in previous trials among patients with advanced melanoma.
“These data demonstrate compelling evidence that adjuvant treatment with KEYTRUDA provides significant recurrence-free survival benefit after surgery in patients with high-risk Stage III melanoma,” explained Roy Baynes from Merck Research Laboratories.
“These are the first data for KEYTRUDA in the adjuvant setting and mark an important advancement for the treatment of resected stage III melanoma. We are pleased to be sharing these data with global regulatory authorities,” Baynes concluded.
Merck is working to submit data from EORTC1325/KEYNOTE-054 to regulatory agencies around the world.