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Association details:
Biomarker:BRAF wild-type
Cancer:Melanoma
Drug:Mekinist (trametinib) (MEK inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Phase 1B Clinical Trial of Trametinib Plus Digoxin in Patients With Unresectable or Metastatic BRAF Wild-type Melanoma

Excerpt:
...BRAF wild-type confirmed, and NRAS mutation assessed....
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Paclitaxel with or without trametinib or pazopanib in advanced wild-type BRAF melanoma (PACMEL): a multicentre, open-label, randomised, controlled phase II trial

Excerpt:
We randomised 111 patients to treatment (paclitaxel, n = 38, paclitaxel–trametinib, n = 36, and paclitaxel–pazopanib, n = 37)….PFS was significantly longer in the paclitaxel–trametinib arm than in single-agent paclitaxel (TR 1.47; 90% CI 1.08–2.01; two-sided P = 0.04)....ORR was significantly higher with paclitaxel and trametinib than with single-agent paclitaxel (42% versus 13%, two-sided P = 0.01), but paclitaxel and pazopanib showed no improvement over single-agent paclitaxel (22% versus 13%, two-sided P = 0.34) (Table 2)...the PACMEL phase II trial found that adding the MEK inhibitor trametinib to paclitaxel chemotherapy significantly improved PFS and ORR in patients with BRAF-wt melanoma, but did not impact OS.
Secondary therapy:
paclitaxel
DOI:
https://doi.org/10.1093/annonc/mdy500