Encorafenib + Binimetinib (BRAF/MEK) Hits 61% ORR in Chinese BRAF V600E NSCLC

Encorafenib is an oral BRAF inhibitor and binimetinib is an oral MEK1/2 inhibitor evaluated in OCEAN II, an ongoing multicenter, open-label Phase 2 study in China enrolling unresectable stage IV BRAF V600E-mutant NSCLC, including treatment-naïve and previously treated patients without prior BRAF/MEK inhibitors (n=63; Phase 2 n=48). At at least 12 months follow-up, ICR-confirmed ORR was 61.1% with 6 CRs (11%), DCR 87.0%, median DoR 17.5 months, median PFS 13.8 months, and median OS 27.9 months, with DoR/OS still immature. Grade ≥3 TEAEs occurred in 56% and 14% discontinued any study drug due to AEs; efficacy appears broadly in-family with PHAROS and dabrafenib/trametinib benchmarks in this uncommon biomarker subset, while BRAF V600E represents only a small fraction of NSCLC.