The Ministry of Food and Drug Safety has approved PD-1 inhibitor immunotherapy Keytruda (pembrolizumab) for adjuvant therapy for melanoma patients who underwent a surgery.
|MSD Korea’s immunotherapy Keytruda|
The latest nod allows Keytruda to be used as an adjuvant treatment for melanoma with lymph node involvement following complete resection of a tumor. The therapy had previously been authorized to treat unresectable and metastatic melanoma only.
The approval was based on the phase-3 KEYNOTE-054 trial that assessed Keytruda’s efficacy as adjuvant therapy in comparison with a placebo.
The study compared the 12-month recurrence-free survival (RFS) and overall survival (OS) of 1,019 stage-3 patients with complete resection of melanoma with those of the placebo group. The results showed that patients treated with Keytruda had 75.4 percent 12-month RFS, versus 61 percent in the placebo group.
Keytruda was effective as an adjuvant treatment after melanoma surgery, regardless of the PD-L1 expression.
In PD-L1 positive patients, those treated with Keytruda showed 77.1 percent 12-month RFS, while the placebo group had 62.6 percent. In the PD-L1 negative group, the numbers stood at 72.2 percent and 52.2 percent, respectively.
“Among locally authorized immunotherapies, Keytruda was the first to win approval as an adjuvant treatment for melanoma. It is meaningful that Keytruda expanded the treatment area of immunotherapies from combo therapy to adjuvant therapy,” said Choi Jae-yeon, director at Oncology Business Unit of MSD Korea.
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