Phase 2 trial (OCEAN II) evaluating encorafenib (450 mg daily) plus binimetinib (90 mg daily total) in 63 Chinese patients with BRAF V600E-mutated metastatic unresectable stage IV NSCLC, including both treatment-naïve and previously treated patients (excluding prior BRAF/MEK inhibitors). Primary endpoints were dose-limiting toxicities (safety lead-in) and confirmed objective response rate by independent central review (pivotal part).
Confirmed ORR by independent central review was 61% (95% CI 47–74%) in the ad hoc analysis; disease control rate 87% (95% CI 75–95%). Median time-to-response was 1.8 months, median duration of response 17.5 months, median PFS 13.8 months, and median OS 27.9 months. Grade ≥3 treatment-related adverse events occurred in 55.6% of patients; 14.3% discontinued any drug due to adverse events.
Single-arm design with no comparator group limits causal inference. The study enrolled only Chinese patients, so generalizability to other ethnic populations is uncertain. Ad hoc efficacy analysis was unplanned, and the upper bound of the PFS confidence interval was not estimable.
Encorafenib plus binimetinib yields a ~61% confirmed response rate and nearly 14-month median PFS in Chinese patients with BRAF V600E-mutated metastatic NSCLC, with a safety profile consistent with prior global data. Clinicians treating this population should be prepared to manage Grade ≥3 toxicities in over half of patients, though discontinuation rates remain relatively low (~14%).
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