{"entity":{"id":"pharos","kind":"trial","name":"PHAROS","aka":[],"tldr":"PHAROS showed that the melanoma combination encorafenib and binimetinib shrinks three quarters of untreated BRAF V600E lung cancers and nearly half of previously treated ones, giving a second approved BRAF plus MEK pair for lung cancer.","summary":"PHAROS treated 98 patients with metastatic BRAF V600E-mutant non-small-cell lung cancer with encorafenib 450 mg daily and binimetinib 45 mg twice daily, 59 of them treatment-naive and 39 previously treated. Dabrafenib plus trametinib had been approved for this population in 2017 on a similar single-arm design.\n\nThe response rate was 75 percent in treatment-naive patients and 46 percent in previously treated patients, with median durations of response of about 40 months and 16.7 months respectively. Nausea, diarrhoea, fatigue and vomiting were the main side effects; the fever that limits dabrafenib and trametinib was uncommon.\n\nThe FDA approved encorafenib with binimetinib for BRAF V600E lung cancer in October 2023. Non-V600 BRAF mutations, about half of BRAF-mutant lung cancers, do not respond to these drugs.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03915951","url":"https://clinicaltrials.gov/study/NCT03915951"},{"label":"Journal of Clinical Oncology 2023","url":"https://doi.org/10.1200/JCO.23.00774"}],"tags":[],"related":[],"cancers":["nsclc","braf-v600e-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf"],"drugs":["encorafenib","binimetinib","dabrafenib-trametinib"],"companies":["pfizer"],"institutions":[],"pathways":["ras-mapk"],"terms":["braf-v600-mutation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03915951","phase":"2","setting":"Metastatic BRAF V600E-mutant non-small-cell lung cancer, treatment-naive or previously treated: encorafenib plus binimetinib","sponsor":"Pfizer","result":"Response rate 75% (treatment-naive, n=59) and 46% (previously treated, n=39); FDA approval October 2023.","yearReported":2023,"enrolled":98,"outcomes":[{"endpoint":"Objective response rate (independent review)","primary":true,"unit":"%","arms":[{"name":"Treatment-naive","n":59,"value":75},{"name":"Previously treated","n":39,"value":46}],"source":"https://doi.org/10.1200/JCO.23.00774"}],"replication":"Consistent with the BRF113928 study of dabrafenib plus trametinib (response rate 64 percent treatment-naive, 63 percent previously treated)."},"route":"/trials/pharos/","neighbours":{"cancer":[{"id":"braf-v600e-nsclc","kind":"cancer","name":"BRAF V600E-mutant non-small-cell lung cancer","route":"/cancers/braf-v600e-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"}],"drug":[{"id":"binimetinib","kind":"drug","name":"Binimetinib","route":"/drugs/binimetinib/"},{"id":"dabrafenib-trametinib","kind":"drug","name":"Dabrafenib + trametinib","route":"/drugs/dabrafenib-trametinib/"},{"id":"encorafenib","kind":"drug","name":"Encorafenib","route":"/drugs/encorafenib/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"pathway":[{"id":"ras-mapk","kind":"pathway","name":"RAS / RAF / MEK / ERK (MAPK)","route":"/pathways/ras-mapk/"}],"term":[{"id":"braf-v600-mutation","kind":"term","name":"BRAF V600E mutation","route":"/terms/braf-v600-mutation/"}]}}