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Erasca to Begin Pivotal Phase III Study of Naporafenib in NRAS-Mutant Melanoma Next Year

NEW YORK – Erasca on Tuesday said it plans to begin the Phase III SEACRAFT-2 trial for its pan-RAF inhibitor naporafenib plus Novartis' MEK inhibitor Mekinist (trametinib) for patients with NRAS-mutant melanoma in the first half of 2024.

The firm said it completed end of Phase II meetings with global health authorities to confirm the Phase III SEACRAFT-2 trial design and provide clarity on the registrational pathway for the naporafenib-Mekinist combination. The trial will include NRAS-mutant melanoma patients who have progressed on or cannot tolerate standard-of-care checkpoint inhibitors. Researchers will evaluate the combination against physicians' choice of cytotoxic chemotherapy or Mekinist monotherapy and track patients' progression-free survival and overall survival in the different treatment arms.

Erasca is also studying the naporafenib-Mekinist combination in a tumor-agnostic trial, which includes patients with RAS Q61X-mutated solid tumors.

The focus on naporafenib comes as Erasca is undergoing a pipeline reprioritization to extend its cash runway into the first half of 2026. On Tuesday, Erasca said it will need to deprioritize the Phase I trial of its SHP2 inhibitor ERAS-601 with Eli Lilly's Erbitux (cetuximab), as well as preclinical programs for an ERAS-5 ULK inhibitor and ERAS-10 protein degrader.

While preliminary data from the ERAS-601-Erbitux trial showed that some patients responded to the regimen, the company said the data do not justify further development of the combination. "To further maximize resources, we have strategically refined our pipeline to focus on programs with the greatest therapeutic potential for patients with high unmet needs using a data-driven approach," Erasca CEO Jonathan Lim said in a statement, adding that the pipeline prioritization will free up enough cash to see through key clinical trial readouts for naporafenib, ERAS-801, and ERAS-007.

The San Diego-based firm plans to report data from studies of its EGFR inhibitor ERAS-801 in glioblastoma and the ERK1/2 inhibitor ERAS-007 in BRAF-mutant colorectal cancer next year.