Therapy Detail
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| Therapy Name | Binimetinib + Encorafenib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Binimetinib | Mektovi | ARRY-162|ARRY-438162|MEK162 | MEK inhibitor (Pan) 22 MEK1 Inhibitor 20 MEK2 Inhibitor 18 | Mektovi (binimetinib) inhibits MEK1 and MEK2 resulting in inhibition of growth factor-mediated signaling and decreased tumor cell proliferation (PMID: 23587417). Mektovi (binimetinib) in combination with Braftovi (encorafenib) is FDA approved for use in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation (FDA.gov). |
| Encorafenib | Braftovi | LGX818 | BRAF Inhibitor 20 | Braftovi (encorafenib) is an inhibitor of Raf kinase with selective activity against BRAF V600E, resulting in growth inhibition (PMID: 24864047). Braftovi (encorafenib) is FDA approved for use in combination with Mektovi (binimetinib) in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, and in combination with Erbitux (cetuximab) in patients with metastatic colorectal cancer with BRAF V600E(FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| BRAF L597S | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the addition of Braftovi (encorafenib) to treatment with Mektovi (binimetinib) resulted in increased growth inhibition in melanoma cell lines harboring BRAF L597S in culture (PMID: 29903896). | 29903896 |
| BRAF D594N | gallbladder cancer | predicted - sensitive | Binimetinib + Encorafenib | Case Reports/Case Series | Actionable | In a Phase II trial (BEAVER), Mektovi (binimetinib) and Braftovi (encorafenib) combination therapy resulted in stable disease in a patient with gallbladder cancer harboring BRAF D594N (J Clin Oncol 39, no. 15_suppl, abstr e15038; NCT03839342). | detail... |
| BRAF V600E | melanoma | sensitive | Binimetinib + Encorafenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) demonstrated improved tolerability profile and efficacy, resulted in a progression-free survival of 14.9 months in patients with advanced melanoma harboring BRAF V600E/K mutations, comparing to 7.3 months in the Zelboraf (vemurafenib) group (HR=0.54, p<0.0001) (PMID: 29573941; NCT01909453), and both BRAF V600E and V600K are on the companion diagnostic. | 29573941 detail... detail... detail... |
| BRAF V600E | melanoma | sensitive | Binimetinib + Encorafenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) resulted in a median overall survival (OS) of 33.6 months, a 1-year OS rate of 77.5%, and a 2-year OS rate of 57.7% in patients with advanced melanoma harboring BRAF V600E/K mutations compared to a median OS of 16.9 months and 1- and 2-year OS rates of 63.1% and 43.2%, respectively, in the Zelboraf (vemurafenib) treated group (PMID: 30219628; NCT01909453). | detail... 30219628 detail... detail... |
| BRAF V600K | melanoma | sensitive | Binimetinib + Encorafenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) resulted in a median overall survival (OS) of 33.6 months, a 1-year OS rate of 77.5%, and a 2-year OS rate of 57.7% in patients with advanced melanoma harboring BRAF V600E/K mutations compared to a median OS of 16.9 months and 1- and 2-year OS rates of 63.1% and 43.2%, respectively, in the Zelboraf (vemurafenib) treated group (PMID: 30219628; NCT01909453). | detail... 30219628 detail... detail... |
| BRAF V600K | melanoma | sensitive | Binimetinib + Encorafenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) demonstrated improved tolerability profile and efficacy, resulted in a progression-free survival of 14.9 months in patients with advanced melanoma harboring BRAF V600E/K mutations, comparing to 7.3 months in the Zelboraf (vemurafenib) group (HR=0.54, p<0.0001) (PMID: 29573941; NCT01909453) and both BRAF V600E and BRAF V600K are on the companion diagnostic. | 29573941 detail... detail... detail... |
| BRAF V600E/K | melanoma | sensitive | Binimetinib + Encorafenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) demonstrated improved tolerability profile and efficacy, resulted in a progression-free survival of 14.9 months in patients with advanced melanoma harboring BRAF V600E/K mutations, comparing to 7.3 months in the Zelboraf (vemurafenib) group (HR=0.54, p<0.0001) (PMID: 29573941; NCT01909453) and both BRAF V600E and V600K are on the companion diagnostic. | 29573941 detail... detail... detail... |
| BRAF V600E/K | melanoma | sensitive | Binimetinib + Encorafenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase III (COLUMBUS) trial that supported FDA approval, Braftovi (encorafenib) in combination with Mektovi (binimetinib) resulted in a median overall survival (OS) of 33.6 months, a 1-year OS rate of 77.5%, and a 2-year OS rate of 57.7% in patients with advanced melanoma harboring BRAF V600E/K mutations compared to a median OS of 16.9 months and 1- and 2-year OS rates of 63.1% and 43.2%, respectively, in the Zelboraf (vemurafenib) treated group (PMID: 30219628; NCT01909453). | detail... detail... detail... 30219628 |
| BRAF G469V NRAS Q61K | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the addition of Braftovi (encorafenib) to treatment with Mektovi (binimetinib) resulted in increased growth inhibition in a melanoma cell line harboring BRAF G469V and NRAS Q61K in culture (PMID: 29903896). | 29903896 |
| BRAF V600E/K | skin melanoma | sensitive | Binimetinib + Encorafenib | Guideline | Actionable | Braftovi (encorafenib) in combination with Mektovi (binimetinib) is included in guidelines as first-line and second-line therapy for patients with metastatic or unresectable cutaneous melanoma harboring BRAF V600E or V600K mutations (PMID: 30959471; NCCN.org). | 30959471 detail... |
| BRAF V600K | skin melanoma | sensitive | Binimetinib + Encorafenib | Guideline | Actionable | Braftovi (encorafenib) in combination with Mektovi (binimetinib) is included in guidelines as first-line and second-line therapy for patients with metastatic or unresectable cutaneous melanoma harboring BRAF V600E or V600K mutations (PMID: 30959471; NCCN.org). | 30959471 detail... |
| BRAF mutant | Advanced Solid Tumor | predicted - sensitive | Binimetinib + Encorafenib | Phase II | Actionable | In a Phase II trial (BEAVER), Mektovi (binimetinib) and Braftovi (encorafenib) combination therapy demonstrated safety and preliminary efficacy in patients with advanced solid tumors harboring BRAF non-V600E mutations, resulting in an objective response rate of 12.5% (1/8), BRAF mutations including class 1 (n=1), class 2 (n=3), and class 3 (n=5) (J Clin Oncol 39, no. 15_suppl, abstr e15038; NCT03839342). | detail... |
| BRAF act mut | Advanced Solid Tumor | sensitive | Binimetinib + Encorafenib | Phase Ib/II | Actionable | In a Phase Ib/II trial, Binimetinib (MEK162), in combination with Encorafenib (LGX818), demonstrated safety and efficacy in patients with BRAF mutant advanced solid tumors (J Clin Oncol 31, 2013 (suppl; abstr 9029)). | detail... |
| BRAF R239Q BRAF L597S | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, the addition of Braftovi (encorafenib) to treatment with Mektovi (binimetinib) increased growth inhibition in patient-derived melanoma cells harboring BRAF L597S, as well as BRAF R239Q, in culture, and resulted in tumor shrinkage in 67% of tumors, increased inhibition of ERK phosphorylation, and increased tumor growth delay compared to either agent alone in a patient-derived xenograft (PDX) model (PMID: 29903896). | 29903896 |
| BRAF V600E | skin melanoma | sensitive | Binimetinib + Encorafenib | Guideline | Actionable | Braftovi (encorafenib) in combination with Mektovi (binimetinib) is included in guidelines as first-line and second-line therapy for patients with metastatic or unresectable cutaneous melanoma harboring BRAF V600E or V600K mutations (PMID: 30959471; NCCN.org). | detail... 30959471 |
| BRAF G469S | gallbladder cancer | predicted - sensitive | Binimetinib + Encorafenib | Phase II | Actionable | In a Phase II trial (BEAVER), combination treatment with Mektovi (binimetinib) and Braftovi (encorafenib) led to stable disease in a gallbladder cancer patient harboring BRAF D594N, with a treatment duration of 4.4 months (Annals of Oncology 32 (2021): S596; NCT03839342). | detail... |
| BRAF G469S | melanoma | predicted - sensitive | Binimetinib + Encorafenib | Case Reports/Case Series | Actionable | In a Phase II trial (BEAVER), Mektovi (binimetinib) and Braftovi (encorafenib) combination therapy resulted in an unconfirmed partial response in a patient with melanoma harboring BRAF G469S (J Clin Oncol 39, no. 15_suppl, abstr e15038; NCT03839342). | detail... |
| BRAF T599dup | melanoma | predicted - sensitive | Binimetinib + Encorafenib | Case Reports/Case Series | Actionable | In a clinical case study, a combination of Mektovi (binimetinib) and Braftovi (encorafenib) resulted in regression of lymphadenopathy, lung nodules, and subcutaneous nodules in a patient with metastatic melanoma harboring BRAF T599dup, and at 9 months from treatment initiation, a partial response was still observed (PMID: 35319964). | 35319964 |
| BRAF D594G | ampulla of Vater cancer | predicted - sensitive | Binimetinib + Encorafenib | Phase II | Actionable | In a Phase II trial (BEAVER), combination treatment with Mektovi (binimetinib) and Braftovi (encorafenib) led to a confirmed partial response in an ampullary cancer patient harboring BRAF D594G, who continued to be on treatment for 5.4 months (Annals of Oncology 32 (2021): S596; NCT03839342). | detail... |
| BRAF V600X | skin melanoma | sensitive | Binimetinib + Encorafenib | Guideline | Actionable | BRAF inhibitor plus MEK inhibitor combination therapy, such as Mektovi (binimetinib) plus Braftovi (encorafenib), is included in guidelines for cutaneous melanoma patients with unresectable or metastatic disease harboring a BRAF V600 mutation (PMID: 31566661; ESMO.org). | 31566661 detail... |
| BRAF V600X | skin melanoma | sensitive | Binimetinib + Encorafenib | Guideline | Actionable | Mektovi (binimetinib) and Braftovi (encorafenib) combination therapy is included in guidelines as a second-line or subsequent therapy for patients with metastatic or unresectable cutaneous melanoma harboring a BRAF V600 activating mutation (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03915951 | Phase II | Binimetinib + Encorafenib | An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer | Recruiting | USA | ITA | ESP | 2 |
| NCT03843775 | Phase Ib/II | Binimetinib + Encorafenib | A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers | Recruiting | USA | 0 |
| NCT03911869 | Phase II | Binimetinib + Encorafenib | An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis (POLARIS) | Terminated | USA | ITA | BEL | 2 |
| NCT04324112 | Phase II | Binimetinib + Encorafenib | Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL | Recruiting | USA | 0 |
| NCT04759846 | Phase I | Binimetinib + Encorafenib | Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma | Not yet recruiting | ITA | ESP | 1 |
| NCT05097599 | Phase II | Binimetinib + Encorafenib Trastuzumab deruxtecan Enfortumab vedotin-ejfv Talazoparib Lorlatinib | Strata PATH (Precision Indications for Approved Therapies) (Strata PATH) | Recruiting | USA | 0 |
| NCT05026983 | Phase II | Binimetinib + Encorafenib | Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases | Recruiting | USA | 0 |
| NCT03839342 | Phase II | Binimetinib + Encorafenib | Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations (BEAVER) | Recruiting | CAN | 0 |
| NCT02159066 | Phase II | Binimetinib + Encorafenib + Ribociclib Binimetinib + Encorafenib Binimetinib + Capmatinib + Encorafenib Binimetinib + Buparlisib + Encorafenib Binimetinib + Encorafenib + Infigratinib | LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma | Active, not recruiting | USA | ITA | ESP | DEU | CAN | 4 |
| NCT05097378 | Phase II | Binimetinib + Encorafenib | Perioperative Encobini in BRAFV600 Mutant Stage III (B/C/D) or Oligometastatic Stage IV Melanoma (PREMIUM) | Not yet recruiting | 1 | |
| NCT01909453 | Phase III | Vemurafenib Encorafenib Binimetinib + Encorafenib | Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma (COLUMBUS) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | 23 |
| NCT04390243 | Phase II | Binimetinib + Encorafenib | Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation | Recruiting | USA | 0 |
| NCT04741997 | Phase I | Binimetinib + Encorafenib + Nivolumab Binimetinib + Encorafenib | Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma | Recruiting | USA | 0 |
| NCT04526782 | Phase II | Docetaxel Binimetinib + Encorafenib | ENCOrafenib With Binimetinib in bRAF NSCLC (ENCO-BRAF) | Recruiting | FRA | 0 |
| NCT01820364 | Phase II | Binimetinib + Encorafenib Encorafenib + Ribociclib Buparlisib + Encorafenib Encorafenib + Infigratinib Capmatinib + Encorafenib | LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma | Terminated | USA | ESP | DEU | CAN | 2 |
| NCT04061980 | Phase II | Binimetinib + Encorafenib Binimetinib + Encorafenib + Nivolumab | Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer | Recruiting | USA | 0 |
| NCT03898908 | Phase II | Binimetinib + Encorafenib | Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain (EBRAIN-MEL) | Recruiting | ESP | 0 |
| NCT02263898 | Phase II | Binimetinib + Encorafenib | Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations | Withdrawn | USA | 0 |
| NCT03973918 | Phase II | Binimetinib + Encorafenib | Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG (BRAF) | Active, not recruiting | USA | 0 |
| NCT03864042 | Phase I | Caffeine + Dextromethorphan + Losartan + Midazolam + Omeprazole Modafinil Bupropion + Rosuvastatin Binimetinib + Encorafenib | Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors | Recruiting | USA | ESP | CAN | BEL | 1 |
| NCT03878719 | Phase I | Binimetinib + Encorafenib | Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma | Recruiting | USA | ITA | 3 |
| NCT03235245 | Phase II | Binimetinib + Encorafenib Ipilimumab + Nivolumab | Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib (EBIN) | Recruiting | ITA | FRA | ESP | DEU | BEL | 3 |
| NCT01543698 | Phase Ib/II | Binimetinib + Encorafenib Binimetinib + Encorafenib + Ribociclib | A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors | Active, not recruiting | USA | ITA | FRA | ESP | CAN | BEL | 3 |
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