Company: ERAS
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0000950170-25-042682
Chunk: 29

Company: Erasca, Inc.
Filing Date: 2025-03-20
Form: 10-K
Item: Item 1
Chunk 29
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IO setting. As presented at the 2024 Triple Meeting, a 40% response rate was observed, including three confirmed responses and one unconfirmed response (uPR). The patient with uPR was still on treatment as of the data cutoff (September 5, 2024). The disease control rate was encouraging at 80%, especially given that these patients have limited treatment options. Finally, 70% of patients remained on treatment as of data cutoff, including all confirmed and unconfirmed responders.

Summary. We believe clinical PoC in patients with NRASm melanoma has been established for the combination of naporafenib and trametinib. Although clinical trial data across separate trials may not be directly comparable due to differences in trial protocols, conditions, and patient populations, these data compare favorably with the clinical activity observed with the standard of care agents used to treat patients with NRASm melanoma who have progressed on immunotherapy.

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Development strategy for naporafenib

Naporafenib’s clinical development plan is centered on the quick and efficient capitalization on the clinical PoC established in patients with NRASm melanoma in the post-IO setting. In December 2023, we announced that the FDA granted FTD to naporafenib in combination with trametinib for the treatment of adult patients with unresectable or metastatic melanoma who have progressed on, or are intolerant to, an anti‑programmed death-1 (ligand 1) (PD‑(L)1)-based regimen, and whose tumors contain an NRAS mutation.

NRAS-mutated melanoma. The frontline standard of care for patients with NRASm melanoma is an anti-PD-1/L-1-based regimen (immunotherapy) where the PD-1/L-1 inhibitor is administered as monotherapy or in combination. The highest unmet medical need in this population is in the post-IO setting, where there is no single global regulatory or accepted SOC. Rather, an analysis of regulatory approvals of drugs for patients with melanoma, published treatment guidelines, and the feedback from an advisory board attended by treating physicians in North America, Europe, and Australia indicate that the treatment choices for this post-IO patient population include cytotoxic chemotherapy (e.g., dacarbazine, temozolomide, etc.), single agent MEK inhibitors (e.g., trametinib, binimetinib, cobimetinib), and clinical trials. In addition, there is