{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T01:56:30Z","timestamp":1791597390595,"version":"4.3.4"},"reference-count":36,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"21","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2023,7,20]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> The combination of encorafenib (BRAF inhibitor) plus binimetinib (MEK inhibitor) has demonstrated clinical efficacy with an acceptable safety profile in patients with BRAF<jats:sup>V600E\/K<\/jats:sup>-mutant metastatic melanoma. We evaluated the efficacy and safety of encorafenib plus binimetinib in patients with BRAF<jats:sup>V600E<\/jats:sup>-mutant metastatic non\u2013small-cell lung cancer (NSCLC). <\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p> In this ongoing, open-label, single-arm, phase II study (ClinicalTrials.gov identifier: NCT03915951 ), patients with BRAF<jats:sup>V600E<\/jats:sup>-mutant metastatic NSCLC received oral encorafenib 450 mg once daily plus binimetinib 45 mg twice daily in 28-day cycles. The primary end point was confirmed objective response rate (ORR) by independent radiology review (IRR). Secondary end points included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival, time to response, and safety. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> At data cutoff, 98 patients (59 treatment-na\u00efve and 39 previously treated) with BRAF<jats:sup>V600E<\/jats:sup>-mutant metastatic NSCLC received encorafenib plus binimetinib. Median duration of treatment was 9.2 months with encorafenib and 8.4 months with binimetinib. ORR by IRR was 75% (95% CI, 62 to 85) in treatment-na\u00efve and 46% (95% CI, 30 to 63) in previously treated patients; median DOR was not estimable (NE; 95% CI, 23.1 to NE) and 16.7 months (95% CI, 7.4 to NE), respectively. DCR after 24 weeks was 64% in treatment-na\u00efve and 41% in previously treated patients. Median PFS was NE (95% CI, 15.7 to NE) in treatment-na\u00efve and 9.3 months (95% CI, 6.2 to NE) in previously treated patients. The most frequent treatment-related adverse events (TRAEs) were nausea (50%), diarrhea (43%), and fatigue (32%). TRAEs led to dose reductions in 24 (24%) and permanent discontinuation of encorafenib plus binimetinib in 15 (15%) patients. One grade 5 TRAE of intracranial hemorrhage was reported. Interactive visualization of the data presented in this article is available at the PHAROS dashboard ( https:\/\/clinical-trials.dimensions.ai\/pharos\/ ). <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> For patients with treatment-na\u00efve and previously treated BRAF<jats:sup>V600E<\/jats:sup>-mutant metastatic NSCLC, encorafenib plus binimetinib showed a meaningful clinical benefit with a safety profile consistent with that observed in the approved indication in melanoma. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.23.00774","type":"journal-article","created":{"date-parts":[[2023,6,4]],"date-time":"2023-06-04T12:00:19Z","timestamp":1685880019000},"page":"3700-3711","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":121,"title":["Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With <i>BRAF<\/i><sup>V600<\/sup>-Mutant Metastatic Non\u2013Small-Cell Lung Cancer"],"prefix":"10.1200","volume":"41","clinical-trial-number":[{"clinical-trial-number":"nct03915951","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5357-4313","authenticated-orcid":false,"given":"Gregory J.","family":"Riely","sequence":"first","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7329-6995","authenticated-orcid":false,"given":"Egbert F.","family":"Smit","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Diseases, Leiden University Medical Center, Leiden, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5740-9654","authenticated-orcid":false,"given":"Myung-Ju","family":"Ahn","sequence":"additional","affiliation":[{"name":"Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South 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