Erasca heads for phase 3 at last

It was all the way back at ASCO 2021 that Novartis first mooted plans for a phase 3 combo study of its pan-RAF inhibitor naporafenib, but it’s taken nearly three years for this to come about. In the meantime, the asset was divested to Erasca, and not long afterwards that company said it was hoping to start the phase 3 Seacraft-2 study in the first half of 2024. After Erasca's $45m private placement this is now coming to fruition: Seacraft-2 has just gone live on clinicaltrials.gov, with the trial, combining naporafenib with Novartis's Mekinist in 470 second-line BRAF inhibitor-naive melanoma patients, to kick off next month. Patients have to have NRAS-mutant disease, and Seacraft-2’s key primary endpoints are OS and PFS versus physician’s choice of dacarbazine, Temodar or Mekinist. Naporafenib is thought to have activity beyond class 1 BRAF mutations (Erasca specifically cites activity at CRAF), and Kinnate Biopharma is pursuing a similar strategy with exarafenib, which it is combining with Pfizer’s Mektovi. However, Erasca and Kinnate have struggled since floating, and the fact Novartis let naporafenib go for just $20m up front plus $80m in equity might not be a great endorsement.

Erasca-sponsored trials of naporafenib

Source: OncologyPipeline.