Drugs / Naporafenib
last change 6 days ago re-read 9 days ago

Naporafenib

Small molecule targets BRAF via inhibition

Developed for
melanoma · non-small cell lung carcinoma · colorectal cancer · ovarian carcinoma
Investigated by
Novartis Pharmaceuticals · Erasca, Inc.

Trials 7

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT05907304 Aug 2023 → Jul 2025 overdue — Erasca, Inc. Active not recruiting No outcome recorded
Phase 1 NCT04294160 Jul 2020 → Sep 2024 colorectal cancer Novartis Pharmaceuticals Terminated No outcome recorded Stop: Business
Phase 1 NCT03333343 Jan 2018 → Oct 2026 expected non-small cell lung carcinoma Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 1 NCT02974725 Feb 2017 → Apr 2024 melanoma, non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded Stop: Business
Phase 1 NCT02607813 Jan 2016 → Feb 2022 melanoma, non-small cell lung carcinoma, ovarian carcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 21 trial
Phase 2 NCT04417621 Oct 2020 → Feb 2027 expected melanoma Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT06346067 Apr 2024 → Apr 2028 expected melanoma Erasca, Inc. Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2024-10-24 Erasca, Inc. Results Erasca Announces Strong Momentum for Naporafenib and RAS Targeting Franchise erasca.com ↗
Positive preliminary Phase 1b SEACRAFT-1 data for naporafenib plus trametinib reinforce therapeutic potential in NRASm melanoma and further support ongoing Phase 3 SEACRAFT-2 trial
2024-05-08 Erasca, Inc. Results Erasca Reports First Quarter 2024 Business Updates and Financial Results erasca.com ↗
We started 2024 strong with compelling survival data from a pooled analysis of mature data for naporafenib plus trametinib in patients with NRAS-mutant (NRASm) melanoma, which showed a near doubling of median overall survival (mOS) versus comparable historical controls,
2023-12-11 Erasca, Inc. Regulatory Erasca Granted FDA Fast Track Designation for Pan-RAF Inhibitor Naporafenib in Patients with Advanced NRAS-Mutated Melanoma erasca.com ↗
2023-04-25 Erasca, Inc. Results Erasca Announces Publication of Promising Clinical Data Supporting the Therapeutic Potential of Naporafenib in Combination with Trametinib in NRAS-Mutant Melanoma erasca.com ↗
Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today 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 (MEKINIST®) in patients with NRAS-mutant (NRASm) melanoma.

All press releases naming this drug 10 releases

DateIssuerRelease

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as naporafenib “Patients and methods: In this phase Ib escalation/expansion study (ClinicalTrials.gov identifier: NCT02974725), the safety, tolerability, and preliminary antitumor activity of...” PMID 36947734 ↗ Mar 2023
2

NCT06346067 ↗

NCT05907304 ↗

Known as ERAS-254 ChEMBL registry synonym — accepted as the source's own label CHEMBL4583691 ↗
Known as LXH254 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02974725 ↗
4

NCT04417621 ↗

NCT03333343 ↗

NCT04294160 ↗

NCT02607813 ↗

Known as PAN-RAF INHIBITOR LXH254 ChEMBL registry synonym — accepted as the source's own label CHEMBL4583691 ↗
Action Inhibit “pan-RAF inhibitor” NCT02607813 ↗
Modality Small molecule — CHEMBL4583691 ↗
Route Oral “A Phase I Dose Finding Study of Oral LXH254 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations” NCT02607813 ↗
Target BRAF “a BRAF/CRAF protein kinases inhibitor” PMID 36947734 ↗ Mar 2023