Company: ERAS
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0000950170-25-042682
Chunk: 31

Company: Erasca, Inc.
Filing Date: 2025-03-20
Form: 10-K
Item: Item 1
Chunk 31
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 SEACRAFT-2 trial, we are evaluating two combination doses of naporafenib and trametinib [400/0.5 and 100/1 (doses are listed as naporafenib mg BID/trametinib mg QD)] as well as single-agent trametinib. Along with the 200/1 dose from the SEACRAFT-1 trial, we aim to identify one dose to incorporate into the potentially registration-enabling portion of the trial.

In Stage 2 of the SEACRAFT-2 trial, we plan to enroll NRASm melanoma patients who have progressed on, or are intolerant to, SOC ICI therapy into a potentially registration-enabling randomized Phase 3 trial in which patients will receive either naporafenib plus trametinib or physician’s choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy). We have designed the trial to demonstrate superiority in PFS and/or OS based on benchmarks from published literature. Important details of the trial design, such as the primary endpoints and choice of therapy in the physician’s choice comparator arm, have been discussed with regulatory authorities. SEACRAFT-2 has the potential for approval based on the high unmet medical need of these patients as well as the alignment with US and European regulators on the NRASm melanoma indication. 

We expect to have Phase 3 Stage 1 randomized dose optimization data in the second half of 2025.

In addition, we have introduced proactive safety management, including mandatory primary rash prophylaxis, that is designed to improve the safety and tolerability of this regimen for patients participating in our trials.

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Other development opportunities. A strong motivation to add naporafenib to our precision oncology pipeline is the potential synergy of naporafenib with our other agents that target the RAS/MAPK pathway. These combinations may enable targeting of other RAS/MAPK pathway mutations beyond NRASm melanoma and may expand the potential impact of naporafenib to larger patient populations.

RAS Franchise: ERAS-0015 pan-RAS molecular glue and ERAS-4001 pan-KRAS small molecule inhibitor

Our RAS franchise consists of two preclinical molecules: ERAS-0015, a pan-RAS molecular glue for which we plan to file the IND in mid-Q2 2025, and ERAS-4001, a pan-KRAS small molecule inhibitor for which we plan