The recommended dose of Keytruda for the adjuvant treatment of adult patients with melanoma is 200 mg administered as an intravenous infusion over 30 minutes every three weeks until disease recurrence, unacceptable toxicity, or for up to 12 months in patients without disease recurrence.
The approval was based on data from the EORTC1325/ Keynote-054 trial, which was carried out in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC).
According to the company, the trial showed that Keytruda significantly prolonged recurrence-free survival (RFS) and reduced the risk of disease recurrence or death by 43% compared to placebo in patients with resected and high-risk stage III melanoma.
Keytruda is an anti-PD-1 therapy, which works by enhancing the ability of the body’s immune system to help detect and fight tumor cells.
It is a humanized monoclonal antibody that inhibits the interaction between PD-1 and its ligands, PD-L1 and PD-L2, enabling to activate T lymphocytes that may affect both tumor cells and healthy cells.
Keytruda is claimed to be the first anti-PD-1 therapy assessed in the adjuvant setting across patients with stage IIIA, IIIB and IIIC melanoma.
The study is a multicenter, randomized, double-blind and placebo-controlled phase 3 trial in patients with completely resected stage IIIA, IIIB or IIIC melanoma.
Merck enrolled 1,019 patients and randomized them 1:1 in the trial to secure Keytruda 200mg every three weeks or placebo for up to one year or until disease recurrence or unacceptable toxicity.
Merck said that Keytruda is currently being studied in more than 900 trials across a wide variety of cancers and treatment settings. Keytruda is already available for the treatment of various disease conditions.
Merck Research Laboratories global clinical development head, chief medical officer and senior vice president Dr Roy Baynes said: “In the fight against cancer, progress is made one step at a time, and today we’re pleased to take another important step – making Keytruda available as an adjuvant therapy for patients with stage III melanoma.
“At Merck, we are committed to transforming the treatment of cancer, as is exemplified by this important advance in the adjuvant treatment of melanoma.”