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Based on previously published Phase III clinical data, Dabrafenib combined Trametinib therapy significantly reduced the risk of recurrence for 12 months in patients with Stage III melanoma with BRAF V600E or V600K mutations.
researchers recently released long-term data on the study.
870 surgically removed patients with BRAF V600E or V600K mutation III melanoma were randomly treated with oral Dabrafenib (doses of 150 mg twice a day) for a period of 12 months in a joint Trametinib (once a day, once a day, 2 mg) or placebo, and the main endpoint of the study was no recurrence and no remote metastasis for 5 years.
follow-up period was 60 months for the combined treatment group and 58 months for placebo.
5 years, the percentage of patients who survived and had no recurrence in the combined treatment group was 52 per cent, and in the placebo group it was 36 per cent (the risk of recurrence or death ratio was 0.51).
65 percent of patients in the combined treatment group who survived and had no distant metastasis, and 54 percent in the placebo group (the risk ratio of distant metastasis or death was 0.55).
there was no significant difference in the occurrence or severity of serious adverse events between groups during follow-up.
a follow-up study of up to 5 years, Dabrafenib combined traminib therapy reduced the risk of recurrence or metastasis in patients with POST-surgery BRAFV600E or V600K mutation Stage III melanoma.
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