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Association details:
| Biomarker: | NRAS Q61K |
|---|---|
| Cancer: | Melanoma |
| Drug: | tunlametinib (HL-085) (MEK inhibitor, MEK1 inhibitor, MEK2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
First-in-human phase I dose-escalation and dose-expansion trial of the selective MEK inhibitor HL-085 in patients with advanced melanoma harboring NRAS mutations
Published date:
01/04/2023
Excerpt:
In the 12 mg cohort, 4 patients (4/15, 26.7%) achieved confirmed PR and 6 patients (6/15, 40.0%) attained SD, providing confirmed ORR of 26.7% and a DCR of 86.7%. Median DoR in this cohort was 2.9 months (95% CI: 0.6, 5.5), and median PFS was 3.6 months (95% CI: 1.8, 5.5)....The HL-085 showed acceptable tolerability and substantial clinical activity in patients with advanced melanoma harboring NRAS mutations.
DOI:
10.1186/s12916-022-02669-7
Trial ID:
Source:
Title:
A first-in-human phase I/II study of HL-085, a MEK Inhibitor, in Chinese patients with NRASm advanced melanoma.
Published date:
05/13/2020
Excerpt:
10 pts achieved tumor shrinkage [ 60% with Q61, 20% with G12D, 10% each with G12S and G13R]. 4 pts ( 2 acral, 1 mucosal and 1 other, each pt has mutaiton type of Q61R,Q61L, Q61K and G12S respectively ) had confirmed partial response(PR) [median treatment duration 26.6 weeks (wks) with longest 47.6 wks]). 6 pts achieved stable disease (SD) (median treatment duration 15.72 wks with longest 24 wks), and 66.7% were over 14 wks . The median PFS was 17.4 wks, and confirmed best ORR was 33.3% with DCR 83.3% ....Our data demonstrated that HL-085 is well tolerated, with manageable side-effects and promising anti-cancer activity in pts with NRASm advanced melanoma.
DOI:
10.1200/JCO.2020.38.15_suppl.10047
Trial ID:
