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Association details:
Biomarker:GNAQ mutation
Cancer:Melanoma
Drug:Koselugo (selumetinib) (MEK inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye

Excerpt:
...mutant Gnaq/Gna11 status...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A clinical trial comparing continuous Selumetinib versus continuous or interrupted Selumetinib in combination with weekly Paclitaxel in Metastatic Uveal Melanoma.

Excerpt:
...To compare between the combination of selumetinib in either a continuous or intermittent schedule with weekly paclitaxel or with selumetinib alone:• Overall Survival time• RECIST Response Rate • Safety and toxicityExploratory EndpointsThese will include, but not be confined to, the predictive value of GNAQ/GNA11 mutation status and a MEK transcriptional signature ( the latter performed using the nCounter analysis system from NanoString technologies). ...
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Effect of selumetinib vs chemotherapy on progression-free survival in uveal melanoma: a randomized clinical trial

Excerpt:
The median progression-free survival was 7 (95% confidence interval (CI), 4.3–8.4) and 15.9 weeks (95% CI, 8.4–21.1; Figure 2a) for those randomized to and treated with chemotherapy (n=49) and selumetinib (n=47), respectively. The hazard ratio for progression-free survival was 0.46 (95% CI, 0.30–0.71; p<0.001) in favor of selumetinib. Similar improvement was observed when limiting analysis to patients with tumor harboring a GNAQ or GNA11 mutation (n=80; Figure 2b).
DOI:
10.1001/jama.2014.6096
Trial ID: