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Therapy Name | Binimetinib + Encorafenib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Binimetinib | Mektovi | ARRY-162|ARRY-438162|MEK162 | MEK inhibitor (Pan) 26 MEK1 Inhibitor 26 MEK2 Inhibitor 24 | 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 25 | 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 patients with metastatic non-small cell lung cancer harboring BRAF V600E, and in combination with Erbitux (cetuximab) in patients with metastatic colorectal cancer with BRAF V600E (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
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 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 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 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 D594G NRAS G12D | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Mektovi (binimetinib) and Braftovi (encorafenib) resulted in a synergistic effect in melanoma cells harboring BRAF D594G and NRAS G12D, with decreased cell viability and Erk phosphorylation and increased apoptosis in culture (PMID: 35385748). | 35385748 |
BRAF D594N | gallbladder cancer | predicted - sensitive | Binimetinib + Encorafenib | Case Reports/Case Series | 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 V600E | glomus tumor | predicted - sensitive | Binimetinib + Encorafenib | Case Reports/Case Series | Actionable | In a clinical case study, treatment with the combination of Mektovi (binimetinib) and Braftovi (encorafenib) resulted in a complete response lasting more than 2 years in a patient with metastatic malignant glomus tumor harboring BRAF V600E (PMID: 39392364). | 39392364 |
BRAF D594G | ampulla of Vater cancer | predicted - sensitive | Binimetinib + Encorafenib | Case Reports/Case Series | 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 remained on treatment for at least 5.4 months (Annals of Oncology 32 (2021): S596; NCT03839342). | detail... |
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 V600E | high grade glioma | sensitive | Binimetinib + Encorafenib | Case Reports/Case Series | Actionable | In a Phase II trial, treatment with the combination of Mektovi (binimetinib) and Braftovi (encorafenib) demonstrated safety and activity in patients with high grade glioma harboring BRAF V600E, resulting in a radiographic response rate of 60% (3/5, 1 complete and 2 partial responses), with stable disease in 1 patient, a median duration of response of 10 months, a median progression-free survival of 9.4 months, and a median overall survival of 14.6 months (PMID: 38446982; NCT03973918). | 38446982 |
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... |
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 V600E MAP2K1 H119Y | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 H119Y in culture (PMID: 36442478). | 36442478 |
BRAF V600E | papillary thyroid carcinoma | sensitive | Binimetinib + Encorafenib | Phase II | Actionable | In a Phase II trial, Mektovi (binimetinib) plus Braftovi (encorafenib) demonstrated safety in patients with BRAF V600E-mutant thyroid cancer and resulted in an objective response rate (ORR) of 54.5% (12/22, 12 partial responses (PR)), with an ORR of 47.1% (8/17, 8 PR) and a disease control rate of 100% (17/17) in the differentiated thyroid cancer cohort (all papillary thyroid cancer), and median duration of response, progression-free survival, and overall survival were not reached (PMID: 38343359). | 38343359 |
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 (Annals of Oncology 32 (2021): S596; NCT03839342). | detail... |
BRAF V600E MAP2K1 F53I | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 F53I in culture (PMID: 36442478). | 36442478 |
BRAF V600E MAP2K1 F53L | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 F53L in culture (PMID: 36442478). | 36442478 |
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 V600E MAP2K1 E203V | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 E203V in culture (PMID: 36442478). | 36442478 |
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 advanced solid tumor patients harboring BRAF non-V600E mutations including class 1 (n=1), class 2 (n=4), and class 3 (n=5), with an objective response rate of 22% (2/9) and a partial response in a patient with ampullary cancer harboring BRAF D594G and an unconfirmed PR in a melanoma patient harboring BRAF G469S (Annals of Oncology 32 (2021): S596; NCT03839342). | detail... |
BRAF V600E | multiple myeloma | sensitive | Binimetinib + Encorafenib | Phase II | Actionable | In a Phase II trial (BIRMA), Mektovi (binimetinib) plus Braftovi (encorafenib) treatment demonstrated safety and efficacy in relapsed/refractory multiple myeloma patients with BRAF V600E, with an overall response rate of 83% (10/12, 1 complete response (CR), 2 near-CR, 6 very good partial responses (PR), and 1 PR), a median duration of response of 4.8 mo, a median progression-free survival of 5.6 mo, and a median overall survival not reached but 66% at 12 mo and 55% at 24 mo (PMID: 36608320; NCT02834364). | 36608320 |
BRAF V600E | Advanced Solid Tumor | predicted - sensitive | Binimetinib + Encorafenib | Phase II | Actionable | In a Phase II trial (BELIEVE), treatment with the combination of Braftovi (encorafenib) and Mektovi (binimetinib) resulted in an objective response rate of 32.7%, median progression-free survival (PFS) of 4.8 months, and 6-month PFS rate of 37.5% in patients with advanced solid tumors harboring BRAF V600E (n=43), other BRAF mutation (n=5), or a BRAF fusion (n=1) (Ann Oncol (2024) 35 (Suppl_2): S497). | detail... |
BRAF V600E MAP2K1 P105_A106del | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 P105_A106del in culture (PMID: 36442478). | 36442478 |
BRAF V600E MAP2K1 F53_Q58delinsL | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 F53_Q58delinsL in culture (PMID: 36442478). | 36442478 |
BRAF V600E MAP2K1 F53C | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 F53C in culture (PMID: 36442478). | 36442478 |
BRAF V600E | thyroid cancer | sensitive | Binimetinib + Encorafenib | Phase II | Actionable | In a Phase II trial, treatment with Mektovi (binimetinib) plus Braftovi (encorafenib) demonstrated safety and activity in patients with BRAF V600E-mutant thyroid cancer, regardless of histological subtype, resulting in an objective response rate of 54.5% (12/22, 12 partial responses), disease control rate of 100% (22/22), and 12-month rate of ongoing response of 90.9%, and median duration of response, median progression-free survival, and median overall survival were not reached (PMID: 38343359). | 38343359 |
BRAF V600E MAP2K1 F53V | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 F53V in culture (PMID: 36442478). | 36442478 |
BRAF V600E MAP2K1 P124S | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 P124S in culture (PMID: 36442478). | 36442478 |
BRAF V600E MAP2K1 F129L | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 F129L in culture (PMID: 36442478). | 36442478 |
BRAF V600E MAP2K1 V60E | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 V60E in culture (PMID: 36442478). | 36442478 |
BRAF V600E MAP2K1 E203K | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 E203K in culture (PMID: 36442478). | 36442478 |
BRAF V600E | ovarian serous carcinoma | predicted - sensitive | Binimetinib + Encorafenib | Case Reports/Case Series | Actionable | In a clinical case study, Braftovi (encorafenib) and Mektovi (binimetinib) combination therapy resulted in durable stable disease lasting at least 3.5 years in a patient with low-grade serous ovarian carcinoma harboring BRAF V600E, who was previously treated with the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) (PMID: 33043759). | 33043759 |
BRAF V600E MAP2K1 K57T | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 K57T in culture (PMID: 36442478). | 36442478 |
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 V600E MAP2K1 I103N | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 I103N in culture (PMID: 36442478). | 36442478 |
BRAF V600E MAP2K1 D67N | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 D67N in culture (PMID: 36442478). | 36442478 |
MAP2K1 K57E | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 K57E in culture (PMID: 36442478). | 36442478 |
BRAF V600E MAP2K1 P124Q | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 P124Q in culture (PMID: 36442478). | 36442478 |
BRAF V600E PTEN del | melanoma | decreased response | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, a melanoma cell line harboring BRAF V600E and engineered via CRISPR-Cas9 to harbor a PTEN knockout demonstrated decreased sensitivity to treatment with Mektovi (binimetinib) and Braftovi (encorafenib) compared to cells with wild-type PTEN in culture (PMID: 38854737). | 38854737 |
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 V600E | malignant fibrous histiocytoma | sensitive | Binimetinib + Encorafenib | Case Reports/Case Series | Actionable | In a clinical case study, treatment with the combination of Mektovi (binimetinib) and Braftovi (encorafenib) resulted in a clinical response after two months in a patient with angiomatoid fibrous histiocytoma harboring BRAF V600E, along with EWSR1-CREB1 (e7:e7), and in a preclinical study, combination treatment with Mektovi (binimetinib) and Braftovi (encorafenib) inhibited viability of cells in culture (PMID: 38885476). | 38885476 |
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 V600E MAP2K1 Q56_G61delinsR | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 Q56_G61delinsR in culture (PMID: 36442478). | 36442478 |
BRAF V600E MAP2K1 F53Y | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 F53Y in culture (PMID: 36442478). | 36442478 |
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 V600E MAP2K1 E102_I103del | melanoma | sensitive | Binimetinib + Encorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) synergistically inhibited viability of a melanoma cell line harboring BRAF V600E and expressing MAP2K1 E102_I103del in culture (PMID: 36442478). | 36442478 |
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 V600E | anaplastic thyroid carcinoma | sensitive | Binimetinib + Encorafenib | Case Reports/Case Series | Actionable | In a Phase II trial, Mektovi (binimetinib) and Braftovi (encorafenib) combination therapy demonstrated safety and activity in patients with thyroid cancer harboring BRAF V600E, resulting in an objective response rate (ORR) of 54.5% (12/22, 12 partial responses (PR)), with an ORR of 80% (4/5, 4 PR) and a disease control rate of 100% (5/5) in patients with anaplastic thyroid cancer, and median duration of response, progression-free survival, and overall survival were not reached (PMID: 38343359). | 38343359 |
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 | lung non-small cell carcinoma | sensitive | Binimetinib + Encorafenib | Guideline | Actionable | Combination of Braftovi (encorafenib) and Mektovi (binimetinib) is included in guidelines as a first-line or subsequent therapy for advanced or metastatic non-small cell lung cancer patients harboring BRAF V600E mutations (NCCN.org). | detail... |
BRAF V600E | lung non-small cell carcinoma | sensitive | Binimetinib + Encorafenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase II trial (PHAROS) that supported FDA approval, Braftovi (encorafenib) and Mektovi (binimetinib) combination therapy resulted in an objective response rate (ORR) of 75% (44/59; 9 complete, 35 partial responses) with a duration of response (DOR) lasting 12 or more months in 59% of treatment-naive patients, and an ORR of 46% (18/39) with a DOR lasting 12 or more months in 33% of previously treated patients with metastatic non-small cell lung cancer harboring BRAF V600E (PMID: 37270692; NCT03915951). | detail... detail... detail... 37270692 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT02263898 | Phase II | Binimetinib + Encorafenib | Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations | Withdrawn | USA | 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 | CHE | CAN | AUS | 0 |
NCT03898908 | Phase II | Binimetinib + Encorafenib | Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain (EBRAIN-MEL) | Active, not recruiting | ESP | 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 | Completed | USA | NLD | ESP | CAN | BEL | 0 |
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 | Active, not recruiting | USA | 0 |
NCT05097599 | Phase II | Binimetinib + Encorafenib Trastuzumab deruxtecan Enfortumab vedotin-ejfv Talazoparib Lorlatinib | Strata PATH (Precision Indications for Approved Therapies) (Strata PATH) | Active, not recruiting | USA | 0 |
NCT03839342 | Phase II | Binimetinib + Encorafenib | Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations (BEAVER) | Active, not recruiting | CAN | 0 |
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 | Completed | USA | ITA | FRA | ESP | CHE | CAN | BEL | AUS | 1 |
NCT05767879 | Phase II | Binimetinib + Encorafenib | (Neo)Adjuvant BRAF/MEK Inhibition in pN1c Melanoma | Recruiting | NLD | 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 |
NCT05270044 | Phase III | Binimetinib + Encorafenib | Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. (COLUMBUS-AD) | Active, not recruiting | SWE | ROU | POL | NOR | NLD | ITA | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 3 |
NCT05615818 | Phase III | Niraparib ZW25 Binimetinib + Encorafenib Futibatinib Cisplatin + Gemcitabine Neratinib + Trastuzumab Ivosidenib | Personalized Medicine for Advanced Biliary Cancer Patients (SAFIR-ABC10) | Recruiting | GBR | FRA | BEL | 0 |
NCT03235245 | Phase II | Binimetinib + Encorafenib Ipilimumab + Nivolumab | Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib (EBIN) | Active, not recruiting | POL | NLD | ITA | GBR | FRA | FIN | ESP | DNK | DEU | 0 |
NCT03973918 | Phase II | Binimetinib + Encorafenib | Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG (BRAF) | Terminated | USA | 0 |
NCT05097378 | Phase II | Binimetinib + Encorafenib | Perioperative Encobini in BRAFV600 Mutant Stage III (B/C/D) or Oligometastatic Stage IV Melanoma (PREMIUM) | Unknown status | GBR | 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 | Completed | USA | NLD | ITA | GBR | ESP | DEU | CHE | CAN | AUS | 0 |
NCT03915951 | Phase II | Binimetinib + Encorafenib | An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer | Active, not recruiting | USA | NLD | ITA | ESP | 1 |
NCT05026983 | Phase II | Binimetinib + Encorafenib | Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases | Recruiting | USA | 0 |
NCT01909453 | Phase III | Vemurafenib Encorafenib Binimetinib + Encorafenib | Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma (COLUMBUS) | Completed | USA | TUR | SWE | SVK | POL | NOR | NLD | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | AUS | ARG | 8 |
NCT03878719 | Phase I | Binimetinib + Encorafenib | Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma | Terminated | ITA | 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 | AUS | ARG | 0 |
NCT04759846 | Phase I | Binimetinib + Encorafenib | Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma | Withdrawn | ITA | ESP | CZE | 0 |
NCT03843775 | Phase Ib/II | Binimetinib + Encorafenib | A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers | Completed | USA | 0 |
NCT05203172 | FDA approved | Encorafenib Binimetinib + Encorafenib Binimetinib + Encorafenib + Ribociclib Binimetinib + Cetuximab + Encorafenib Binimetinib | The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials | Recruiting | USA | SVK | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | AUS | 4 |
NCT03563729 | Phase II | Pembrolizumab Binimetinib + Encorafenib Ipilimumab + Nivolumab Dabrafenib + Trametinib | Melanoma Metastasized to the Brain and Steroids (MEMBRAINS) | Recruiting | DNK | 0 |
NCT04324112 | Phase II | Binimetinib + Encorafenib | Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL | Recruiting | USA | 0 |
NCT04221438 | Phase II | Binimetinib + Encorafenib | Testing Treatment With Encorafenib and Binimetinib Before Surgery for Melanoma With Lymph Node Involvement | Active, not recruiting | USA | 0 |
NCT04390243 | Phase II | Binimetinib + Encorafenib | Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation | Terminated | USA | 0 |