eClinical Technology and Industy News

Erasca Doses First Patient in SEACRAFT-1 Phase 1b Trial Evaluating Naporafenib Plus Trametinib in Patients with RAS Q61X Solid Tumors

Anti-tumor activity in patients with NRAS Q61X melanoma and KRAS Q61X NSCLC supports tissue agnostic development in RAS Q61X solid tumors

Initial Phase 1b combination data from SEACRAFT-1 expected in Q2-Q4 2024

Dosing of first patient in pivotal SEACRAFT-2 trial in NRAS-mutant melanoma expected in H1 2024

Excerpt from the Press Release:

SAN DIEGO, Aug. 29, 2023 (GLOBE NEWSWIRE) — Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced dosing of the first patient in the SEACRAFT-1 Phase 1b trial evaluating pan-RAF inhibitor naporafenib in combination with MEK inhibitor trametinib (MEKINIST®) in patients with RAS Q61X solid tumors.

“Naporafenib has been dosed in over 500 patients to date, establishing its safety, tolerability, and preliminary proof-of-concept (PoC) in multiple indications,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “SEACRAFT-1 will explore the potential of naporafenib plus trametinib in patients with RAS Q61X solid tumors, which affects over 150,000 patients in the United States and Europe. This tissue agnostic approach is based on the encouraging anti-tumor activity generated by Novartis in patients with NRAS Q61X melanoma or KRAS Q61X non-small cell lung cancer (NSCLC). We look forward to sharing signal-seeking efficacy data in relevant tumor types from SEACRAFT-1 between the second and fourth quarters of 2024. In addition, we are on track to initiate SEACRAFT-2, a pivotal Phase 3 trial to evaluate naporafenib plus trametinib in patients with NRAS-mutant (NRASm) melanoma, in the first half of 2024.”

SEACRAFT-1 is an open-label Phase 1b trial that will examine the safety, tolerability, and preliminary efficacy of naporafenib in combination with trametinib (MEKINIST®) in previously treated patients aged 12 and older with locally advanced unresectable or metastatic RAS Q61X solid tumor malignancies including NRAS, HRAS, and KRAS mutations. Initial Phase 1b combination signal-seeking efficacy data in relevant tumor types is expected between Q2 and Q4 2024.

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