Updated overall survival analysis from the phase II PHAROS study of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic non-small cell lung cancer

Abstract

The phase II PHAROS study previously showed that encorafenib plus binimetinib has antitumor activity in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (mNSCLC). In PHAROS, 98 patients (59 treatment-na & iuml;ve; 39 previously treated) received encorafenib 450 mg once daily and binimetinib 45 mg twice daily. We report updated results from data cutoff of March 14, 2025. The median duration of treatment with both encorafenib and binimetinib was 16.3 months in treatment-na & iuml;ve and 5.5 months in previously treated patients. After median follow-up for overall survival (OS) of 52.3 months in treatment-na & iuml;ve patients, mOS was 47.6 months (95% CI, 31.3 to not estimable); 4-year OS probability was 49% (95% CI, 35 to 62). After median follow-up for OS of 48.2 months in previously treated patients, mOS was 22.7 months (95% CI, 14.1 to 32.6); 4-year OS probability was 31% (95% CI, 16 to 47). In treatment-na & iuml;ve and previously treated groups, 58% and 26% received >= 1 subsequent systemic anticancer treatment, respectively. Safety profile remained consistent with that in previous analyses. Although comparisons across trials should be done cautiously, to our knowledge, encorafenib plus binimetinib was associated with the longest mOS reported to date with targeted treatment in patients with treatment-na & iuml;ve BRAF V600E-mutant mNSCLC.