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Keytruda for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection, approved by FDA


The FDA ( U.S. Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ), anti-PD-1 therapy, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection based on results from the EORTC1325/KEYNOTE-054 trial.

This pivotal phase 3 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer ( EORTC ), has demonstrated that Pembrolizumab significantly prolonged recurrence-free survival ( RFS ), reducing the risk of disease recurrence or death by 43% compared to placebo in patients with resected, high-risk stage III melanoma ( hazard ratio, HR=0.57 [ 95% CI, 0.46, 0.70 ]; p less than 0.001 ).
Pembrolizumab is the first anti-PD-1 therapy studied in the adjuvant setting across patients with stage IIIA ( more than 1 mm lymph node metastasis ), IIIB and IIIC melanoma.

EORTC1325/KEYNOTE-054 is a multicenter, randomized, double-blind, placebo-controlled phase 3 trial in patients with completely resected stage IIIA ( more than 1 mm lymph node metastasis ), IIIB or IIIC melanoma.
In total, the study enrolled 1,019 patients who were randomized 1:1 to receive Pembrolizumab 200 mg every three weeks ( n=514 ) or placebo ( n=505 ) for up to one year or until disease recurrence or unacceptable toxicity.
Randomization was stratified by the American Joint Committee on Cancer 7th edition ( AJCC ) stage ( IIIA versus IIIB versus IIIC 1-3 positive lymph nodes versus IIIC greater than or equal to 4 positive lymph nodes ) and geographic region ( North America, European countries, Australia and other countries ).
Patients had to undergone lymph node dissection and, if indicated, radiotherapy within 13 weeks prior to starting treatment.

The major efficacy outcome measures were investigator-assessed RFS in the whole population and in the population with PD-L1 positive tumors where 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 occurs first.
Patients underwent imaging every 12 weeks after the first dose of Pembrolizumab for the first two years, then every six months from year three to five, and then annually.

Among the 1,019 patients, the baseline characteristics were median age of 54 years ( range, 19 to 88 years; 25% age 65 or older ); 62% male; and ECOG PS of 0 ( 94% ) and 1 ( 6% ).
Sixteen percent had stage IIIA; 46% had stage IIIB; 18% had stage IIIC ( 1-3 positive lymph nodes ) and 20% had stage IIIC ( greater than or equal to 4 positive lymph nodes ); 50% were BRAF V600 mutation positive, and 44% were BRAF wild-type; and 84% had PD-L1 positive melanoma determined by tumor proportion score ( Tumor Proportion Score [ TPS ] greater than or equal to 1% ) measured with an investigational use only ( IUO ) assay.

Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible.

The most common adverse reaction ( reported in at least 20% of study patients ) was diarrhea ( 28% ). ( Xagena )

Source: Merck, 2019

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