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Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor in multiple RAS/MAPK pathway-driven tumors
Initial SEACRAFT-1 Phase 1b combination data in RAS Q61X solid tumors expected between Q2-Q4 2024
Initiation of pivotal SEACRAFT-2 in NRASm melanoma expected in H1 2024
SAN DIEGO, Feb. 14, 2024 (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 two clinical trial collaboration and supply agreements (CTCSAs) with Novartis (NYSE:NVS) for the MEK inhibitor trametinib (MEKINIST®).
The agreements will support the clinical development of the pan-RAF inhibitor naporafenib in combination with trametinib for the treatment of patients with RAS Q61X solid tumors in the Phase 1b SEACRAFT-1 trial and in patients with previously treated NRAS-mutant (NRASm) unresectable or metastatic melanoma in the randomized, pivotal Phase 3 SEACRAFT-2 trial. Erasca is sponsoring the trials, and Novartis is supplying trametinib at no cost.
"We are excited to work with Novartis to further evaluate the promising clinical development of naporafenib in combination with trametinib in our SEACRAFT trials as part of our two lead indications: NRASm melanoma and RAS Q61X solid tumors," said Jonathan E. Lim, M.D., Erasca's chairman, CEO, and co-founder. "Both trials are supported by compelling anti-tumor activity with a tolerable and manageable adverse event profile demonstrated in clinical data generated by Novartis. We expect to initiate our SEACRAFT-2 Phase 3 trial in the first half of 2024 and report initial SEACRAFT-1 Phase 1b combination data in RAS Q61X solid tumors between the second and fourth quarters of 2024."
In the United States and Europe, approximately 150,000 patients with RAS Q61X solid tumors are diagnosed annually, particularly in melanoma, non-small cell lung cancer (NSCLC), thyroid cancer, colorectal cancer, pancreatic cancer, and other tumor types. Approximately 20-30% of patients with melanoma have NRAS mutations, which is an aggressive form that accounts for approximately 50,000 new cancer cases annually in the United States and Europe. Both RAS Q61X solid tumors and NRASm melanoma represent high unmet needs with no approved targeted therapies for these respective mutation types. Erasca is exploring whether naporafenib in combination with trametinib can improve outcomes and help provide meaningful therapeutic benefit for these advanced solid tumor indications.
About Naporafenib
Naporafenib (formerly LXH254) is a potent and selective pan-RAF inhibitor, with a potential first-in-class and best-in-class profile. Naporafenib has been dosed in over 500 patients to date, whereby safety, tolerability, pharmacokinetics, and pharmacodynamics have been established in both monotherapy and select combinations. Clinical proof-of-concept (PoC) has been established for the combination with trametinib for patients with NRAS-mutant (NRASm) melanoma, which includes NRAS Q61X melanoma, and preliminary clinical PoC has been established for the combination with trametinib for patients with RAS Q61X in non-small cell lung cancer (NSCLC). Erasca plans to focus initially on advancing and securing regulatory approval for naporafenib plus trametinib in NRASm melanoma as part of the planned pivotal Phase 3 SEACRAFT-2 trial and in RAS Q61X tissue agnostic solid tumors as part of the Phase 1b SEACRAFT-1 trial, respectively. Erasca is also exploring additional combinations of naporafenib with other proprietary therapeutic agents in our pipeline. Naporafenib has received FDA Fast Track Designation for patients with unresectable or metastatic NRASm melanoma who have progressed on, or are intolerant to, an anti-PD(L)-1 based regimen.
