FDA Approves Keytruda for Adjuvant Treatment of Stage 3 Melanoma


Pembrolizumab (Keytruda, Merck) is the first anti-PD-1 therapy approved in the adjuvant setting across patients with stage 3 melanoma.

Officials with the FDA have granted approval to Merck’s pembrolizumab (Keytruda) for the adjuvant treatment of melanoma with involvement of lymph node(s) following complete resection, according to a press release. This is the first FDA approval for pembrolizumab in the adjuvant setting and the fourth approval for pembrolizumab in skin cancers.

The approval is based on phase 3 data demonstrating that pembrolizumab significantly prolonged recurrence-free survival (RFS) in patients with resected, high-risk stage 3 melanoma. The trial was conducted in collaboration with the European Organization for Research and Treatment of Cancer (EORTC).

The EORTC1325/KEYNOTE-054 trial included 1019 patients who were randomized to receive pembrolizumab 200 mg every 3 weeks or a placebo for up to 1 year or until disease recurrence or unacceptable toxicity. Among the trial participants, 16% had stage 3A, 46% had stage 3B, 18% had stage 3C (1-3 positive lymph nodes), and 20% had stage 3C (³4 positive lymph nodes), 50% were BRAF V600 mutation positive, and 44% were BRAF wild-type. Eighty-four percent had PD-L1 positive melanoma determined by tumor proportion score.

For the trial, the investigators assessed RFS in the whole population and in the population with PD-L1 positive tumors. Patients underwent imaging every 12 weeks after the first dose of pembrolizumab for the first 2 years, then every 6 months from year 3 to 5, and then annually.

According to the data, treatment with pembrolizumab reduced the risk of disease recurrence or death by 43% compared with placebo (HR=0.57 [95% Cl, 0.46, 0.70]; p<0.001].

“The collaborative study from EORTC and Merck demonstrated a significant reduction in the risk of cancer returning after surgery,” study chair Dr Alexander Eggermont, director general at the Gustave Roussy Cancer Institute and professor of oncology at University of Paris-Saclay, said in the release. “This approval in the adjuvant setting marks another milestone in the treatment of melanoma patients, who often have a high risk of disease recurrence.”

Pembrolizumab is the first anti-PD-1 therapy studied in the adjuvant setting across patients with stage 3A (>1 mm lymph node metastasis), 3B, and 3C melanoma, according to Merck.


FDA Approves Merck’s Keytruda (pembrolizumab) for the Adjuvant Treatment of Patients with Melanoma with Involvement of Lymph Node(s) Following Complete Resection [news release]. Merck’s website. https://www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-keytruda-pembrolizumab-adjuvant-treatmen. Accessed February 19, 2019.

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