Erasca announced the publication of results in the Journal of Clinical Oncology from the expansion arm of a Phase 1b open label study evaluating pan-RAF inhibitor naporafenib plus MEK inhibitor trametinib in patients with NRAS-mutant, NRASm, melanoma. Publication Highlights: Initial Evidence for the Efficacy of Naporafenib in Combination with Trametinib in NRAS-Mutant Melanoma: Results From the Expansion Arm of a Phase 1b, Open-Label Study. Dual blockade of the RAS/MAPK pathway has proven to be highly efficacious in patients with BRAF-mutant melanoma. However, similar dual blockade has not been approved in patients with NRASm melanoma. This Novartis-sponsored Phase 1b study evaluated the safety and preliminary efficacy of naporafenib plus trametinib at two recommended doses for expansion in patients with NRAS-mutant melanoma. Naporafenib plus trametinib demonstrated promising preliminary antitumor activity in heavily pretreated patients; The safety profile of the combination was manageable with low discontinuation rates due to adverse events; Naporafenib 200 mg BID + trametinib 1 mg QD vs. naporafenib 400 mg BID + trametinib 0.5 mg QD: Confirmed objective response rate: 46.7% vs. 13.3%, Median duration of response: 3.75 months vs. 3.75 months, Median progression-free survival: 5.5 months vs. 4.2 months.
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