Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ERAS-254, LXH254
Naporafenib · 2 trials · 2 indications
Incidence and severity of treatment-emergent AEs and serious AEs
* Progression free survival (PFS) based on assessment of radiographic imaging per RECIST v1.1 * Survival status
Based on assessment of Objective response rate (ORR) per RECIST version 1.1
| Arm | Type | Description |
|---|---|---|
| Stage 1 Dose selection Lead-in Arm 1 | EXPERIMENTAL | Naporafenib + Trametinib Naporafenib (ERAS-254) 100 mg administered orally twice daily (BID) Trametinib 1 mg once daily (QD) |
| Stage 1 Dose selection Lead-in Arm 2 | EXPERIMENTAL | Naporafenib + Trametinib Naporafenib (ERAS-254) 400 mg administered orally twice daily (BID) Trametinib 0.5 mg once daily (QD) |
| Stage 1 Dose selection Lead-in Arm 3 Trametinib monotherapy | ACTIVE_COMPARATOR | Trametinib 2 mg once daily (QD) |
| Stage 2 Arm A | EXPERIMENTAL | Naporafenib + Trametinib Naporafenib (ERAS-254) BID oral administration with Trametinib QD at the dose selected in Stage 1 |
| Stage 2 Arm B - Physician's Choice | ACTIVE_COMPARATOR | * Dacarbazine 1000 mg/m2 intravenously (IV) on Day 1 of each 21-day cycle OR * Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle OR * Trametinib monotherapy, 2 mg PO QD |
| Naporafenib + Trametinib | EXPERIMENTAL | Naporafenib (ERAS-254) 200 mg twice daily (BID) Trametinib 1 mg once daily (QD) |
| Name | Type | Description |
|---|---|---|
| Naporafenib | DRUG | Naporafenib (ERAS-254) is an experimental Pan-Raf inhibitor |
| Dacarbazine | DRUG | Dacarbazine IV - Day 1 |
| Temozolomide | DRUG | Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle |
| Trametinib | DRUG | Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2. |
Key Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Age ≥ 18 years 3. Histologically or cytologically confirmed unresectable or metastatic cutaneous (includes acral) melanoma. 4. Documentation of an NRAS mutation (tumor tissue or blood) prior to first dose of study dr...
Naporafenib is an investigational oral medicine being studied for advanced or metastatic NRAS-mutant melanoma and for advanced or metastatic solid tumors with RAS Q61X mutations. It is given in combination with trametinib in these studies and is not yet approved for any use.
Naporafenib is a small-molecule inhibitor that targets RAF1 and BRAF, kinases in the RAS-MAPK signaling pathway. Blocking these RAF proteins is intended to dampen the pathway activity that drives tumor growth in RAS- or NRAS-mutant cancers.
Naporafenib is being developed by Erasca, Inc., a clinical-stage oncology company that trades on the Nasdaq under the ticker ERAS. Erasca refers to the compound in its trial documents as ERAS-254.
Naporafenib is in Phase 3 development. The lead program is the SEACRAFT-2 trial in advanced or metastatic NRAS-mutant melanoma, and a separate Phase 1 study is evaluating the drug in advanced or metastatic solid tumors with RAS Q61X mutations.
Naporafenib is being studied in NCT06346067, a Phase 3 trial called SEACRAFT-2 that combines it with trametinib in NRAS-mutant melanoma, and in NCT05907304, a Phase 1 trial of the same combination in RAS Q61X-mutant solid tumors. Both are active and no longer recruiting.
Yes. Naporafenib and ERAS-254 are the same investigational compound. ERAS-254 is the internal code used by the developer, Erasca, Inc., and naporafenib is the international nonproprietary name used in the trial titles for both the Phase 3 and Phase 1 studies.