A Randomized Trial of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or FOLFIRI/Cetuximab in Chinese Patients With BRAFV600E Mutant Metastatic Colorectal Cancer: The NAUTICAL Study - PubMed

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The NAUTICAL study is a Phase II trial evaluating encorafenib and cetuximab versus irinotecan-based regimens in Chinese patients with BRAFV600E mutant metastatic colorectal cancer (mCRC).
BRAFV600E mutation is present in 3%-5% of CRC cases in China and is associated with aggressive disease and poor prognosis.
The study includes a Safety Lead-In (SLI) phase and a randomized phase comparing treatment efficacy, safety, and Quality of Life (QoL).
No dose-limiting toxicity was observed in the SLI phase (N = 10).
In the randomized phase (N = 97), the encorafenib/cetuximab (Doublet) arm showed superior progression-free survival (PFS) of 4.2 months vs. 2.5 months in the Control arm (HR: 0.37, p = 0.0004).
Overall survival (OS) was also longer in the Doublet arm (11.6 months vs. 8.2 months, HR: 0.55).
Treatment-related adverse events were common but more severe in the Control arm.
Quality of Life (QoL) measures consistently favored the Doublet arm, showing improved health status and reduced deterioration risk.
The study concludes that encorafenib and cetuximab combination offers significant clinical benefits, manageable safety, and QoL advantages for Chinese patients with BRAFV600E mutant mCRC.

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