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Keytruda improves RFS for resected high-risk melanoma
Merck announced that a phase 3 trial of pembrolizumab reached its primary endpoint of improved RFS compared with placebo among patients with surgically resected high-risk melanoma.
Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — is currently indicated for the treatment of patients with unresectable or metastatic melanoma, in addition to the treatment other cancer types.
Investigators conducted a randomized, double-blind phase 2 study, evaluating IV pembrolizumab 200 mg — every 21 days for up to a year — as adjuvant therapy compared with placebo for 1,019 patients with resected high-risk melanoma (stages IIIa, IIIb and IIIc).
RFS served as the primary endpoint. Secondary endpoints included distant metastases-free survival and OS.
Results from the phase 3 EORTC1325/KEYNOTE-054 trial showed pembrolizumab significantly increased RFS (HR = 0.57, 98.4% CI, 0.43-0.74) compared with placebo.
Investigators will present results at an upcoming meeting and submit them to regulatory authorities.
“This result shows a significant advancement for patients that could potentially change the way melanoma is treated in the future,” Alexander Eggermont, MD, PhD, director general at the Gustave Roussy Cancer Institute and professor of oncology at University of Paris-Saclay, said in a manufacturer-issued press release.