{"id":"encorafenib-binimetinib","rwe":[{"pmid":"40411977","year":"2025","title":"Efficacy of encorafenib plus binimetinib in patients with BRAF-mutated melanoma brain metastases: Results from the Dutch Melanoma Treatment Registry.","journal":"European journal of cancer (Oxford, England : 1990)"},{"pmid":"40310541","year":"2025","title":"Adverse effects of systemic advanced melanoma therapies-do BRAF/MEK inhibitors increase the incidence of mesenteric panniculitis?","journal":"European radiology"},{"pmid":"40223207","year":"2025","title":"Cardiotoxicity in patients with metastatic melanoma treated with BRAF/MEK inhibitors: a real-world analysis of incidence, risk factors, and reversibility.","journal":"Acta oncologica (Stockholm, Sweden)"},{"pmid":"41646100","year":"2024","title":"Comparative effectiveness among BRAF plus MEK inhibitors for patients with BRAF V600-mutant melanoma.","journal":"ESMO real world data and digital oncology"},{"pmid":"38716655","year":"2024","title":"Real-world efficacy and safety of BRAF-targeted therapy for patients with advanced melanoma: A single-center retrospective study in Japan.","journal":"The Journal of dermatology"}],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT03973918","NCT05203172","NCT03915951","NCT04657991","NCT03864042","NCT02928224","NCT02159066","NCT03693170","NCT05926960","NCT01909453","NCT05954546","NCT04741997","NCT04800822","NCT03878719","NCT01543698","NCT04044430","NCT05097599","NCT03911869","NCT04585815","NCT05260684"],"aliases":[],"patents":[],"pricing":[],"allNames":"encorafenib + binimetinib","offLabel":[],"timeline":[{"date":"2016","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase 3 trial (Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF ) — Melanoma"},{"date":"2020","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal ) — BRAF V600E-mutant Metastatic Colorectal Cancer"},{"date":"2022","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patient) — Advanced Solid Tumors"},{"date":"2029","type":"neutral","milestone":"Phase 4 Initiated","description":"Phase 4 trial (The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib fo) — Solid Tumors"}],"aiSummary":"Encorafenib + binimetinib is a dual BRAF/MEK inhibitor combination approved for BRAF V600E/K mutant melanoma and other solid tumors. This fixed-dose regimen targets two sequential steps in the MAPK signaling pathway, providing enhanced efficacy and improved tolerability compared to monotherapy approaches.","brandName":"encorafenib + binimetinib","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"This arm of the Strata PATH trial will assess the clinical benefit of Braftovi® (encorafenib) + Mekt","explanation":"Cancer cells often have mutations in the BRAF gene that cause them to grow uncontrollably. Encorafenib directly blocks the abnormal BRAF protein, cutting off one growth signal. However, cancer cells can sometimes bypass this by using a backup pathway involving another protein called MEK. Binimetinib blocks this MEK protein, preventing the cancer from escaping through that alternative route.\n\nBy using both drugs together, the combination attacks the cancer cell's growth machinery from two angles simultaneously. This dual approach is more effective than using just one drug alone, because it reduces the cancer's ability to develop resistance. The drugs work on the same pathway but at different checkpoints, like closing two doors instead of one to prevent escape.\n\nThis combination approach is particularly effective in melanomas and other cancers that carry specific BRAF mutations. The pairing also allows doctors to use lower doses of each drug while maintaining effectiveness, which often results in fewer side effects compared to higher doses of a single agent.","oneSentence":"This arm of the Strata PATH trial will assess the clinical benefit of Braftovi® (encorafenib) + Mekt","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"encorafenib-binimetinib","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Cancer","phase":"discontinued","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03973918","phase":"Phase 2","title":"Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG","status":"Terminated","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","isPivotal":false,"enrollment":5,"indication":"High Grade Glioma","completionDate":"2022-04","primaryEndpoint":"The goal of this study is to estimate the efficacy of encorafenib and binimetinib as measured by radiographic response in recurrent high-grade primary brain tumors."},{"nctId":"NCT05203172","phase":"Phase 4","title":"The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib fo","status":"Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":46,"indication":"Solid Tumors","completionDate":"2029-07","primaryEndpoint":"The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib"},{"nctId":"NCT03915951","phase":"Phase 2","title":"An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lun","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":98,"indication":"Non-small Cell Lung Cancer","completionDate":"2022-09","primaryEndpoint":"This is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in combination with binimetinib in patients with BRAFV600E-mut"},{"nctId":"NCT04657991","phase":"Phase 3","title":"A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients ","status":"Active Not Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":257,"indication":"Melanoma","completionDate":"2026-01","primaryEndpoint":"The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metas"},{"nctId":"NCT03864042","phase":"Phase 1","title":"Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patient","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":56,"indication":"Advanced Solid Tumors","completionDate":"2022-07","primaryEndpoint":"This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK)"},{"nctId":"NCT02928224","phase":"Phase 3","title":"Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":702,"indication":"BRAF V600E-mutant Metastatic Colorectal Cancer","completionDate":"2019-02","primaryEndpoint":"This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/"},{"nctId":"NCT02159066","phase":"Phase 2","title":"LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced B","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":158,"indication":"Melanoma","completionDate":"2023-01","primaryEndpoint":"The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in combination with targeted agents after progression on LGX818/MEK162 combination therapy, as well as the safet"},{"nctId":"NCT03693170","phase":"Phase 2","title":"Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal ","status":"Completed","sponsor":"Pierre Fabre Medicament","isPivotal":false,"enrollment":95,"indication":"BRAF V600E-mutant Metastatic Colorectal Cancer","completionDate":"2020-06","primaryEndpoint":"The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal ca"},{"nctId":"NCT05926960","phase":"Phase 2","title":"A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":38,"indication":"Melanoma","completionDate":"2026-02","primaryEndpoint":"The purpose of this study is to learn about the effects of 3 study medicines (encorafenib, binimetinib, pembrolizumab) compared to 2 study medicines (ipilimumab and nivolumab) given for the treatment "},{"nctId":"NCT01909453","phase":"Phase 3","title":"Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":921,"indication":"Melanoma","completionDate":"2016-11","primaryEndpoint":"This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with loc"},{"nctId":"NCT05954546","phase":"N/A","title":"A Study to Compare How Effective is Encorafenib Plus Binimetinib in Real-world and Clinical Trial Se","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":275,"indication":"Metastatic Melanoma","completionDate":"2023-12","primaryEndpoint":"Brief summary The purpose of this study is to compare how effective, encorafenib plus binimetinib is in the real-world and clinical trial settings."},{"nctId":"NCT04741997","phase":"Phase EARLY1","title":"Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma","status":"Recruiting","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","isPivotal":false,"enrollment":50,"indication":"Melanoma Stage III","completionDate":"2026-07","primaryEndpoint":"The purpose of this study is to assess rate of disease relapse and hazard rate of disease relapse after neoadjuvant therapy based on the statuses of pathologic complete response or non-pathologic comp"},{"nctId":"NCT04800822","phase":"Phase 1","title":"PF-07284892 in Participants With Advanced Solid Tumors","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":53,"indication":"Solid Tumor","completionDate":"2024-06","primaryEndpoint":"The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lor"},{"nctId":"NCT03878719","phase":"Phase 1","title":"Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or ","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":1,"indication":"Melanoma","completionDate":"2022-08","primaryEndpoint":"This is a multicenter Phase 1b, open-label study to evaluate the pharmacokinetic, safety and efficacy of binimetinib and encorafenib co-administered to adolescent patients with BRAF V600-mutant advanc"},{"nctId":"NCT01543698","phase":"Phase 1/2","title":"A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advan","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":189,"indication":"Solid Tumors Harboring a BRAF V600 Mutation","completionDate":"2023-03","primaryEndpoint":"This is a multi-center, open-label, dose finding, Phase Ib dose escalation study to estimate the MTD(s) and/or RP2D(s) for the dual combination of LGX818 and MEK162 and the triple combination of LGX81"},{"nctId":"NCT04044430","phase":"Phase 1","title":"Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colo","status":"Terminated","sponsor":"University of California, San Francisco","isPivotal":false,"enrollment":2,"indication":"Metastatic Colon Adenocarcinoma","completionDate":"2022-07","primaryEndpoint":"This phase I/II trial studies the side effects and how well encorafenib, binimetinib, and nivolumab work in treating patients with microsatellite stable, BRAFV600E gene-mutated colorectal cancer that "},{"nctId":"NCT05097599","phase":"Phase 2","title":"StrataPATH™ (Precision Indications for Approved Therapies)","status":"Terminated","sponsor":"Strata Oncology","isPivotal":false,"enrollment":11,"indication":"Cancer","completionDate":"2024-06","primaryEndpoint":"StrataPATH™ is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populati"},{"nctId":"NCT03911869","phase":"Phase 2","title":"An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":13,"indication":"Brain Metastases","completionDate":"2022-01","primaryEndpoint":"This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV6"},{"nctId":"NCT04585815","phase":"Phase 1/2","title":"Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced N","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":34,"indication":"Carcinoma, Non-Small-Cell Lung","completionDate":"2023-05","primaryEndpoint":"Phase 1b/Phase 2 Umbrella Study; open-label, multi-center, parallel group study."},{"nctId":"NCT05260684","phase":"N/A","title":"Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":716,"indication":"Melanoma","completionDate":"2023-12","primaryEndpoint":"This study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL3187723"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":3,"trialStats":{"total":2,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}