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Therapeutic efficacy of Trametinib

1.BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma  

Trametinib as a Single Agent

The safety and efficacy of Trametinib were evaluated in an international, multi-center, randomized (2:1), open-label, active-controlled trial (the METRIC study; NCT01245062) in 322 patients with BRAF V600E or V600K  mutation-positive, unresectable or metastatic melanoma. 

The METRIC study demonstrated a statistically significant increase in PFS in the patients treated with  Trametinib. Table 20 and Figure 1 summarize the PFS results.

In supportive analyses based on independent radiologic review committee (IRRC) assessment, the PFS results  were consistent with those of the primary efficacy analysis.

Trametinib with Dabrafenib

The safety and efficacy of Trametinib administered with dabrafenib were evaluated in an international,  randomized, double-blind, active-controlled trial (the COMBI-d study; NCT01584648).

The COMBI-d study demonstrated statistically significant improvements in PFS and OS. Table 21 and Figure 2  summarize the efficacy results.

from FDA，2024.03