Encorafenib + Binimetinib (BRAF/MEK) Delivers 75% ORR and 30 mo PFS in BRAF V600E mNSCLC

Encorafenib, a BRAF inhibitor, plus the MEK inhibitor binimetinib was tested in the single‑arm Phase 2 PHAROS study (NCT03915951), treating 59 untreated and 39 previously treated BRAF V600E‑mutant metastatic NSCLC patients (≈1.3% of mNSCLC) with 450 mg/45 mg oral dosing. Treatment‑naïve patients achieved 75% ORR, median DOR 40.0 mo, median PFS 30.2 mo and 3‑yr OS 53%, while pre‑treated patients showed 46% ORR, DOR 16.7 mo, PFS 9.3 mo and OS 22.7 mo; common toxicities were nausea (52%), diarrhea (44%) and fatigue (33%), leading to dose reductions in 26% and discontinuations in 16%. For context, the current standard dabrafenib + trametinib reports ORR 64‑68% and median PFS ≈10 mo with pyrexia in 56% of patients, so PHAROS nearly triples first‑line PFS without adding obvious safety burdens.