marked.bio

MEK inhibitor · small molecule

binimetinib

22 active trials across 7 of our biomarkers, targeting MEK1/2. 4 active approvals for a biomarker on marked.bio.

Also known as MEK162, ARRY-162, Mektovi.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
encorafenib with binimetinib
FDA, 2023
metastatic, BRAF V600E FDA approval 11/10/2023. Source
EU (EMA), 2024
advanced, BRAF V600E WS/2538 (Braftovi + Mektovi), EC decision 29/08/2024. Source
Braftoviencorafenib page 		BRAF V600E NSCLC Approved 2023 Approved 2024

In the FDA approval summary

PHAROS single-arm, 59 untreated; 39 previously treated
Response 75% (untreated); 46% (previously treated) (62-85; 30-63)Lasting not reached (untreated); 16.7 months (previously treated)

Serious side effects 38%Stopped for side effects 16%

Trial details and side effects
Patients
BRAF V600E NSCLC (NCT03915951)
Most common side effects
fatigue 61%, nausea 58%, diarrhoea 52%, musculoskeletal pain 48%, vomiting 37%, abdominal pain 32% (98 patients)
Notes
Encorafenib with binimetinib. Side effects from the Braftovi US label rev. 02/2026.
Source
FDA approval summary

In the EU product information

PHAROS single-arm, 59 untreated; 39 previously treated
Response 75% (untreated); 46% (previously treated) (62-85; 30-63)Lasting 40.0 months (untreated); 16.7 months (previously treated)

Trial details and side effects
Patients
BRAF V600E NSCLC (NCT03915951)
Most common side effects
fatigue 61%, nausea 58%, diarrhoea 52%, musculoskeletal pain 48%, vomiting 37%, abdominal pain 32% (98 patients)
Notes
EU SmPC section 5.1 (PHAROS, updated analysis). Side effects from the US label.
Source
EU product information
encorafenib with binimetinib
FDA, 2018
unresectable or metastatic, BRAF V600E or V600K Label 1.1 with binimetinib, BRAF V600E or V600K. Year confirmed: FDA approval announced 27/06/2018. Source
EU (EMA), 2018
unresectable or metastatic, BRAF V600 mutation MA 19/09/2018. Source
BraftoviBroader labelencorafenib page 		BRAF V600E melanoma Approved 2018 Approved 2018

COLUMBUS vs vemurafenib, 192 vs 191 patients
PFS 14.9 months vs 7.3 months, HR 0.54 (0.41-0.71)Response 63% vs 40%OS 33.6 months vs 16.9 months, HR 0.67 (0.53-0.84)

Stopped for side effects 5%

Trial details and side effects
Patients
BRAF V600E or V600K melanoma (NCT01909453)
Most common side effects
fatigue 43%, nausea 41%, vomiting 30%, abdominal pain 28%, arthralgia 26% (192 patients)
Notes
Encorafenib with binimetinib. Braftovi US label rev. 02/2026.
Source
US label

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
BRAF V600E 19 52 Phase 3
KRAS G12D 2 18 Phase 2
MSI-H / dMMR 2 2 Phase 3
KRAS G12C 1 18 Phase 1
ALK fusion 0 3 –
EGFR exon 19 deletion / L858R 0 1 –
ROS1 fusion 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of binimetinib.

  1. Pierre Fabre Medicament 2
  2. Pfizer 2

Trials

22 of 70 trials shown

  1. Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

    Active, not recruiting Phase 3 Pierre Fabre Medicament Started 2022Primary completion 2027-03 NCT05270044

    encorafenib FDA EUbinimetinib FDA EU

    Available tumour sample for central determination of the BRAF V600E/K mutation.

    BRAF V600EStatus may be outdated, last updated 2023-11-22Melanoma

  2. A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

    Active, not recruiting Phase 3 Pfizer Started 2021Primary completion 2026-10 NCT04657991

    encorafenib FDA EUbinimetinib FDA EUpembrolizumab

    Documented evidence of a BRAF V600E or V600K mutation in melanoma tumor tissue as previously determined by either PCR or NGS-…

    BRAF V600EMelanoma

  3. Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

    Active, not recruiting Phase 3 Massachusetts General Hospital Started 2020Primary completion 2026-12 NCT03803553

    FOLFIRIleucovorinfluorouracilirinotecannivolumab FDA EUencorafenibbinimetinibcetuximabtrastuzumabpertuzumab

    Presence of deficient (d) DNA mismatch repair (dMMR) may be assessed by IHC for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of…

    MSI-H / dMMRMetastatic Colon Cancer, Stage III Colon Cancer

  4. Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases

    Recruiting Phase 2 Grupo Español Multidisciplinar de Melanoma Started 2025Primary completion 2028-01 NCT06887088

    encorafenib FDA EUbinimetinib FDA EUcemiplimab

    A documented mutation in BRAF-V600 in the tumor tissue.

    BRAF V600EMelanoma BRAF V600E/K Mutated, Melanoma and Brain Metastases

  5. Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2023Primary completion 2028-08 NCT05554367

    binimetinibpalbociclib

    Patients must have KRAS/NRAS/HRAS or RAF mutations or rare RAF fusions as determined by the ComboMATCH screening assessment

    KRAS G12DExocrine Pancreas Carcinoma, Malignant Solid Neoplasm, Ovarian Low Grade Serous Adenocarcinoma, Stage IV Ovarian Cancer AJCC v8

  6. Perioperative Encobini in BRAFV600 Mutant Stage III (B/C/D) or Oligometastatic Stage IV Melanoma

    Active, not recruiting Phase 2 CCTU- Cancer Theme Started 2023Primary completion 2026-01 NCT05097378

    encorafenib FDA EUbinimetinib FDA EUStandard Adjuvant Treatment

    AJCC 8th edition stage III (B/C/D), or extracranial oligometastatic stage IV BRAFV600 mutant melanoma, based on histological/cytological and radiological assessments for which…

    BRAF V600EMelanoma, Cancer

  7. Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer

    Active, not recruiting Phase 2 Pierre Fabre Medicament Started 2022Primary completion 2024-05 NCT05195632

    encorafenib FDA EUbinimetinib FDA EU

    Presence of B-Raf Proto-Oncogene, Serine/Threonine Kinase (BRAF) V600E mutation in tumor tissue previously determined by a local assay at any time prior to scre…

    BRAF V600ENon-Small Cell Lung Cancer

  8. Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis

    Active, not recruiting Phase 2 UNICANCER Started 2022Primary completion 2026-05 NCT04074096

    binimetinib FDA EUencorafenib FDA EUpembrolizumab

    Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis

    BRAF V600EMalignant Melanoma, BRAF V600 Mutation, Brain Metastases

  9. ENCOrafenib With Binimetinib in bRAF NSCLC

    Active, not recruiting Phase 2 Intergroupe Francophone de Cancerologie Thoracique Started 2021Primary completion 2025-07 NCT04526782

    encorafenib FDA EUbinimetinib FDA EU

    Presence of a BRAFV600E mutation in lung cancer tissue as determined by a local laboratory assay.

    BRAF V600ENon Small Cell Lung Cancer, BRAF V600E

  10. Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2021Primary completion 2027-02 NCT05026983

    binimetinib FDA EUencorafenib FDA EU

    Presence of BRAFV600 mutation in tumor tissue previously determined by a local assay (including immunohistoche…

    BRAF V600EClinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Pathologic Stage IV Cutaneous Melanoma AJCC v8

  11. A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

    Recruiting Phase 2 SWOG Cancer Research Network Started 2021Primary completion 2027-06 NCT04511013

    binimetinib FDA EUencorafenib FDA EUipilimumabnivolumab

    Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified labo…

    BRAF V600EAcral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Malignant Neoplasm in the Brain

  12. Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer

    Active, not recruiting Phase 2 Providence Health & Services Started 2020Primary completion 2027-12 NCT04061980

    binimetinib FDA EUencorafenib FDA EUnivolumab

    …cally (or cytologically) confirmed diagnosis of metastatic, radioiodine (RAI) refractory, BRAFV600E/M mutant differentiated thyroid cancer (DTC)

    BRAF V600EBRAF NP_004324.2:p.V600M, BRAF V600E Mutation Present, Metastatic Thyroid Gland Carcinoma, Refractory Thyroid Gland Carcinoma

  13. Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2020Primary completion 2026-05 NCT04324112

    binimetinib FDA EUencorafenib FDA EU

    Participants must have BRAF V600 mutation as confirmed from fresh bone marrow aspirate, peripheral blood sample, or lymph …

    BRAF V600EHairy Cell Leukemia

  14. Melanoma Metastasized to the Brain and Steroids

    Recruiting Phase 2 Inge Marie Svane Started 2018Primary completion 2024-06 NCT03563729

    pembrolizumabipilimumabnivolumabencorafenib FDA EUbinimetinib FDA EUdabrafenib FDA EUtrametinib FDA EU

    For arm E specifically: Tumor cells must harbor BRAF mutation.

    BRAF V600EStatus may be outdated, last updated 2023-07-13Malignant Melanoma

  15. Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib

    Active, not recruiting Phase 2 European Organisation for Research and Treatment of Cancer - EORTC Started 2018Primary completion 2023-10 NCT03235245

    nivolumabipilimumabencorafenib FDA EUbinimetinib FDA EU

    …te Combination of Immunotherapy in Patients With Unresectable or Metastatic Melanoma With BRAF V600 Mutation : an EORTC Randomized Phase II Study (EBIN)

    BRAF V600EUnresectable Stage III Melanoma, Stage IV Melanoma

  16. Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2016Primary completion 2027-12 NCT02910700

    binimetinib FDA EUdabrafenib FDA EUencorafenib FDA EUnivolumabtrametinib FDA EU

    … With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

    BRAF V600EMetastatic Malignant Neoplasm in the Brain, Metastatic Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7

  17. Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2015Primary completion 2027-12 NCT02465060

    adavosertibafatinibbinimetinibcapivasertibcopanlisibcrizotinibdabrafenibDasatinibdefactiniberdafitinibfexagratinibipatasertib

    …candidate for Z1M based on local Clinical Laboratory Improvement Act (CLIA) assessment of mismatch repair deficiency (MMRd) by immunohistochemistry (IHC) or microsatellite instability (MSI) status by polyme…

    MSI-H / dMMRAdvanced Lymphoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma, Breast Carcinoma

  18. Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer

    Recruiting Phase 1 National Cancer Institute (NCI) Started 2022Primary completion 2027-03 NCT05111561

    ZEN-3694binimetinib

    Solid tumor with genomic alteration(s) activating RAS signaling including activating KRAS, NRAS, HRAS, or BRAF mutations, inactivating NF1 mutations, or BRAF fusions

    KRAS G12CKRAS G12DBRAF V600EAdvanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Triple-Negative Breast Carcinoma

  19. A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.

    Active, not recruiting Phase 1 Pfizer Started 2022Primary completion 2027-08 NCT05355701

    claturafenibbinimetinib FDA EUcetuximab FDA EUmidazolamfluorouracilleucovorinoxaliplatin

    Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required.

    BRAF V600EMelanoma, Non-Small-Cell Lung Cancer, Thyroid Cancer, Glioma

  20. Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

    Recruiting Phase 1 Rina Plattner Started 2022Primary completion 2028-07 NCT04903119

    Nilotinib 100mgNilotinib 200mgNilotinib 300mgNilotinib 400mgdabrafenib FDA EUtrametinib FDA EUencorafenib FDA EUbinimetinib FDA EU

    3.1.2 Patients must have a BRAF V600 mutation.

    BRAF V600EMetastatic Melanoma, BRAF Gene Mutation

  21. Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma

    Recruiting Early Phase 1 H. Lee Moffitt Cancer Center and Research Institute Started 2021Primary completion 2027-04 NCT04741997

    encorafenib FDA EUbinimetinib FDA EUnivolumab

    Melanoma must have a BRAFV600 mutation (using a CLIA-validated assay), either stage III (B/C/D) or Stage IV (AJCC 8th e…

    BRAF V600EMelanoma Stage III, Melanoma Stage IV, BRAF V600 Mutation

  22. Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

    Active, not recruiting Early Phase 1 H. Lee Moffitt Cancer Center and Research Institute Started 2018Primary completion 2024-12 NCT03543969

    encorafenib FDA EUbinimetinib FDA EUnivolumab

    … must have cytologically or histologically-confirmed unresectable melanoma that harbors a BRAF V600E mutation determined by pyrosequencing assay or equivalent genotyping assay in a Clinical …

    BRAF V600EMelanoma (Skin), Skin Cancer, Skin Melanoma, Skin Carcinoma