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Association details:
Biomarker:GNA11 mutation
Cancer:Uveal 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:
To assess the progression-free survival (PFS) in three separate patient populations with uveal melanoma: Patients on COHORT 1 (guanine nucleotide binding protein [G protein], q polypeptide [Gnaq]/G protein, alpha 11 [Gna11] mutant uveal melanoma; temozolomide [TMZ]/dacarbazine [DTIC] naive) treated with AZD6244 (selumetinib) or TMZ (or DTIC); patients on both COHORT 1 and COHORT 2 (Gnaq/Gna11 mutant and Gnaq/Gna11 wild-type uveal melanoma; TMZ/DTIC naive) treated with AZD6244 or TMZ (or DTIC); and patients on COHORT 3 (Gnaq/Gna11 mutant or wild-type uveal melanoma; previously treated with TMZ/DTIC) treated with AZD6244.
Trial ID:
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: