Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. This marks the first approval for Keytruda in the adjuvant setting and the fourth approval for its use in skin cancers.
The approval was supported by data from the phase 3, multicenter, randomized, double-blind, placebo-controlled EORTC1325/KEYNOTE-054 trial (N=1019) which included patients with completely resected stage IIIA (>1mm lymph node metastasis), IIIB, or IIIC melanoma. Patients were randomized to either Keytruda 200mg every 3 weeks or placebo for up to 1 year or until disease recurrence or unacceptable toxicity. The major efficacy outcomes were investigator-assessed recurrence-free survival (RFS) in the whole population as well as in those with PD-L1 positive tumors; RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis) or death, whichever occurred first.
In the trial, treatment with Keytruda led to significantly longer RFS, decreasing the risk of disease recurrence or death by 43% vs placebo in patients with resected, high-risk stage III melanoma (hazard ratio [HR] 0.57, 95% CI, 0.46, 0.70; P <.001). The most common adverse event was diarrhea, reported in 28% of study patients.
“Keytruda has demonstrated significant improvement in recurrence-free survival among stage III melanoma patients when compared to a placebo, and we now have a new option to help patients who have a high risk of recurrence,” said Dr Alain Algazi, associate clinical professor of medicine, Department of Medicine, Hematology/Oncology, University of California, San Francisco, Medical Center.
Keytruda, a human programmed death receptor-1 (PD-1)-blocking antibody, is already approved to treat various skin, lung, head and neck, urothelial, hematologic, gastrohepatic, and gynecologic cancers. It is supplied as a 50mg lyophilized powder for reconstitution and a 100mg/4mL solution, both in single-dose vials for IV infusion.
For more information call (855) 398-7832 or visit Keytruda.com.