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Association details:
| Biomarker: | NRAS mutation |
|---|---|
| Cancer: | Melanoma |
| Drug: | Mekinist (trametinib) (MEK inhibitor) + naporafenib (ERAS-254) (BRAF inhibitor, pan-RAF inhibitor, cRAF inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
ERASCA GRANTED FDA FAST TRACK DESIGNATION FOR PAN-RAF INHIBITOR NAPORAFENIB IN PATIENTS WITH ADVANCED NRAS-MUTATED MELANOMA
Published date:
12/11/2023
Excerpt:
Erasca...announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to naporafenib in combination with trametinib (MEKINIST®) for the treatment of adult patients with unresectable or metastatic melanoma who have progressed on, or are intolerant to, an anti‑programmed death-1 (ligand 1) (PD‑(L)1)-based regimen, and whose tumors contain an NRAS mutation (NRASm).
Source:
Title:
Initial Evidence for the Efficacy of Naporafenib in Combination With Trametinib in NRAS-Mutant Melanoma: Results From the Expansion Arm of a Phase Ib, Open-Label Study
Published date:
03/22/2023
Excerpt:
In this phase Ib escalation/expansion study (ClinicalTrials.gov identifier: NCT02974725), the safety, tolerability, and preliminary antitumor activity of naporafenib (LXH254), a BRAF/CRAF protein kinases inhibitor, were explored in combination with trametinib in patients with...NRAS-mutant melanoma (escalation and expansion arms)....In expansion, the objective response rate, median duration of response, and median progression-free survival were 46.7% (95% CI, 21.3 to 73.4; 7 of 15 patients), 3.75 (95% CI, 1.97 to not estimable [NE]) months, and 5.52 months, respectively....Naporafenib plus trametinib showed promising preliminary antitumor activity in patients with NRAS-mutant melanoma.
DOI:
10.1200/JCO.22.02018
Trial ID:
