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FDA approves Keytruda for adjuvant treatment of melanoma
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The FDA approved pembrolizumab for adjuvant treatment of patients who have melanoma with lymph node involvement who underwent complete resection.
This is the first U.S. approval for pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — in the adjuvant setting and the fourth for skin cancer treatment.
The FDA based the approval on results of the randomized phase 3 EORTC1325/KEYNOTE-054 trial, which included 1,019 patients (median age, 54 years; range, 19-88; 62% men) with completely resected stage IIIA (16%), IIIB (46%) or IIIC melanoma. All patients had ECOG performance status of 0 (94%) or 1 (6%), half (50%) had BRAF V600 mutations, and 84% had PD-L1-positive disease as determined by tumor proportion score measured with an investigational assay.
Researchers assigned 514 patients to receive pembrolizumab dosed at 200 mg every 3 weeks. The other 505 patients received placebo. Treatment continued for up to 1 year or until disease recurrence or unacceptable toxicity.
Results showed pembrolizumab-treated patients achieved significantly longer RFS (HR = 0.57; 95% CI, 0.46-0.7).
The most common adverse reaction in the pembrolizumab group was diarrhea (28%).
“The collaborative study from EORTC and Merck demonstrated a significant reduction in the risk of cancer returning after surgery,” Alexander M.M. Eggermont, MD, PhD, study chair and director general at Gustave Roussy Cancer Institute, said in a Merck-issued press release. “This approval in the adjuvant setting marks another milestone in the treatment of [patients with melanoma], who often have a high risk of disease recurrence.”
Pembrolizumab already is approved in the United States for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-containing chemotherapy.
The agent also is approved for treatment of specific patient groups with melanoma, lung cancer, hepatocellular carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, gastric cancer, cervical cancer, Merkel cell carcinoma and microsatellite instability-high cancers.