Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 small molecule being developed for advanced or metastatic solid tumors and advanced or metastatic NRAS-mutant melanoma. It is currently in Phase 3 clinical development and has not been approved by the FDA.
Naporafenib targets RAF1 and BRAF, which are kinases involved in the RAS signaling pathway. By inhibiting these targets, it aims to disrupt tumor cell growth in cancers with RAS mutations.
Naporafenib is being developed by Erasca, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ERAS.
Naporafenib is in Phase 3 clinical development for advanced or metastatic NRAS-mutant melanoma. It is also being studied in a Phase 1 trial for advanced or metastatic solid tumors. It is investigational and not yet FDA approved.
Naporafenib is being studied in two active trials. NCT05907304 is a Phase 1 trial in advanced or metastatic solid tumors with RAS Q61X mutations. NCT06346067, called SEACRAFT-2, is a Phase 3 trial in NRAS-mutant melanoma.
Yes, Naporafenib is also known as ERAS-254. Both names refer to the same investigational drug being developed by Erasca, Inc.