Revolution Medicines has dosed the first subject in the Phase III RASolve 301 trial with the RAS (ON) multi-selective inhibitor, daraxonrasib (RMC-6236) for locally advanced or metastatic RAS mutant non-small cell lung cancer (NSCLC).
These subjects have undergone treatment before.
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The open-label, randomised, global trial will assess the efficacy and safety of the therapy against docetaxel chemotherapy.
It aims to enrol roughly 420 NSCLC subjects across the globe who have undergone one to two previous therapy lines for advanced disease, including treatments with anti-programmed cell death protein 1 (PD-1)/anti-programmed cell death ligand 1 (PD-L1) agents as well as platinum-based chemotherapy.
The trial specifically targets core patients with NSCLC harbouring RAS mutations at position G12, while also considering an expanded group with additional RAS mutations.
The two primary endpoints of the trial are to measure progression-free survival (PFS) and overall survival (OS) in the core group.
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By GlobalDataSecondary endpoints will evaluate OS, PFS, and the objective response rate (ORR) within the expanded patient population.
Revolution Medicines’ decision to test daraxonrasib as a standalone treatment was based on preliminary evidence from a single-arm trial, which indicated a favourable safety profile and anti-tumour activity.
The therapy is also under investigation in the randomised RASolute 302 trial, a Phase III study assessing it against standard chemotherapy in second line subjects with metastatic pancreatic ductal adenocarcinoma (PDAC), who were treated before.
Revolution Medicines chairman and CEO Mark Goldsmith said: “We are pleased that dosing is underway in the RASolve 301 Phase III clinical trial, an important step in developing daraxonrasib, a highly innovative compound that targets a diverse array of RAS mutations that drive tumour growth in 30% of NSCLC cases.
“For the vast majority of these RAS cancer drivers, there are currently no approved targeted drugs that can be used in place of chemotherapy. In this trial we are collaborating with physicians globally to evaluate the potential of daraxonrasib as a new therapy for people living with RAS mutant lung cancer.”
