Company: ERAS
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0000950170-25-042682
Chunk: 30

Company: Erasca, Inc.
Filing Date: 2025-03-20
Form: 10-K
Item: Item 1
Chunk 30
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 no clear preference for what type of chemotherapy or MEK inhibitor should be administered. The best reference data for chemotherapy in patients with NRASm melanoma are from the NEMO trial. The patient composition was 82% treatment-naïve, 16% 2nd line, 2% 3rd line or more. The major strength of these reference data is this is the largest and most recent phase 3 dataset in which all patients had NRASm melanoma and are relatively homogeneous, with the vast majority being treatment-naïve. The major weakness is that only 21% of patients had received prior IO therapy. In the NEMO trial, the ORR for chemotherapy was 7%, the mPFS was only 1.5 months, and mOS was 10.1 months. Furthermore, the NEMO trial showed that the MEK inhibitor binimetinib had an ORR of 15%, a mPFS of 2.8 months, and a mOS of 11.0 months. As described above, the mOS observed for chemotherapy and binimetinib in NEMO may overestimate what will be observed in the control arm of the SEACRAFT-2 trial. A cross-trial comparison suggests that the combination of pan-RAF inhibitor plus MEK inhibitor may be superior to MEK inhibition alone or standard of care chemotherapy. We are testing this hypothesis in the SEACRAFT-2 randomized controlled trial in the post-IO setting for potential registration.

Clinical development plan for naporafenib 

Naporafenib is our most advanced clinical-stage program. We believe it has the potential to change the standard of care indications with high unmet medical need, such as patients with NRASm melanoma, as well as patients with RAS/MAPK solid tumors.

SEACRAFT-1. The SEACRAFT-1 trial is a signal-seeking Phase 1b trial in patients with RAS/MAPK solid tumors. We believe that while the preliminary SEACRAFT-1 data do not support further exploration of a tissue-agnostic indication, they do reinforce the potential of the ongoing Phase 3 SEACRAFT-2 trial in patients with NRASm melanoma.  

SEACRAFT-2. The SEACRAFT-2 trial, which we initiated in the first half of 2024, is formally testing the hypothesis supported by the clinical PoC data in patients with NRASm melanoma. In Stage 1 of the