Therapy Detail

Therapy Name Vemurafenib + Cobimetinib
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cobimetinib Cotellic GDC-0973 MEK inhibitor (Pan) 20 MEK1 Inhibitor 20 MEK2 Inhibitor 18 Cotellic (cobimetinib) is an allosteric inhibitor of MEK1/2, resulting in inhibition of extracellular signal-related kinase 2 (ERK2) phosphorylation and activation and decreased tumor cell proliferation (PMID: 22084396, PMID: 27956260). Cotellic (cobimetinib) is FDA approved for melanoma patients with BRAF V600E or V600K, in combination with Zelboraf (vemurafenib) (FDA.gov).
Vemurafenib Zelboraf RO5185426|PLX4032 RAF Inhibitor (Pan) 17 Zelboraf (vemurafenib) inhibits BRAF V600E, wild-type BRAF, ARAF, and CRAF (PMID: 20179705), which may result in an inhibition of the MAPK signaling pathway resulting in a reduction of tumor cell proliferation (PMID: 20823850). Zelboraf (vemurafenib) is FDA approved for BRAF V600E-mutant melanoma and for BRAF V600-positive Erdheim-Chester disease (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF V600X melanoma sensitive Vemurafenib + Cobimetinib Phase III Actionable In a Phase III trial, combination treatment with Zelboraf (vemurafenib) and Cotellic (cobimetinib) resulted in an improved progression-free survival of 12.3 months compared to 7.2 months with Zelboraf (vemurafenib) alone among patients with BRAF V600-mutated metastatic melanoma (PMID: 27480103; NCT01689519). 27480103
BRAF V600X melanoma sensitive Vemurafenib + Cobimetinib Guideline Actionable Zelboraf (vemurafenib) and Cotellic (cobimetinib) combination therapy is included in melanoma guidelines for patients with metastatic or unresectable disease harboring a BRAF V600 activating mutation (NCCN.org). detail...
BRAF V600K melanoma sensitive Vemurafenib + Cobimetinib FDA approved Actionable In a Phase III trial (coBRIM) that supported FDA approval, treatment with the combination of Zelboraf (vemurafenib) and Cotellic (cobimetinib) resulted in an improved progression-free survival of 12.3 months, compared to 7.2 months with Zelboraf (vemurafenib) plus placebo, among patients with BRAF V600-mutated metastatic melanoma, which included patients identified to harbor BRAF V600E or BRAF V600K (PMID: 27480103; NCT01689519). 27480103
BRAF V600E MAP2K1 K57T refractory hairy cell leukemia predicted - sensitive Vemurafenib + Cobimetinib Clinical Study Actionable In a clinical case study, a single patient with hairy cell leukemia who relapsed after initial response to Zelboraf (vemurafenib) was found to have acquired multiple clones with Mek/Erk activating mutations, of which the MAP2K1 K57T clone became dominant, and demonstrated a sustained response greater than 12 months to combined Zelboraf (vemurafenib) and Cotellic (cobimetinib) treatment (PMID: 30341394). 30341394
BRAF V600E/K melanoma sensitive Vemurafenib + Cobimetinib FDA approved Actionable In a Phase III trial (coBRIM) that supported FDA approval, treatment with the combination of Zelboraf (vemurafenib) and Cotellic (cobimetinib) resulted in an improved progression-free survival of 12.3 months, compared to 7.2 months with Zelboraf (vemurafenib) plus placebo, among patients with BRAF V600-mutated metastatic melanoma, which included patients identified to harbor BRAF V600E or BRAF V600K (PMID: 27480103; NCT01689519). 27480103
BRAF V600E melanoma sensitive Vemurafenib + Cobimetinib FDA approved Actionable In a Phase III trial (coBRIM) that supported FDA approval, treatment with the combination of Zelboraf (vemurafenib) and Cotellic (cobimetinib) resulted in an improved progression-free survival of 12.3 months, compared to 7.2 months with Zelboraf (vemurafenib) plus placebo, among patients with BRAF V600-mutated metastatic melanoma, which included patients identified to harbor BRAF V600E or BRAF V600K (PMID: 27480103; NCT01689519). 27480103
BRAF V600E colorectal cancer sensitive Vemurafenib + Cobimetinib Preclinical - Cell line xenograft Actionable In a preclinical study, the combination of Cotellic (cobimetinib) and Zelboraf (vemurafenib) inhibited tumor growth in a cell line xenograft model of colorectal cancer harboring BRAF V600E (PMID: 28649441). 28649441
Clinical Trial Phase Therapies Title Recruitment Status
NCT03005639 Phase II Vemurafenib + Cobimetinib ML29255 Neoadjuvant Vemurafenib and Cobimetinib Melanoma Withdrawn
NCT03543969 Phase I Vemurafenib + Cobimetinib Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma Recruiting
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Nivolumab + Ipilimumab Vemurafenib + Cobimetinib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) Recruiting
NCT02908672 Phase III Vemurafenib + Cobimetinib Atezolizumab + Vemurafenib + Cobimetinib A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma Active, not recruiting
NCT02693535 Phase II Vemurafenib + Cobimetinib Regorafenib Vismodegib Bosutinib Palbociclib Cetuximab Axitinib Pembrolizumab Temsirolimus Dasatinib Pertuzumab + Trastuzumab Crizotinib Sunitinib Olaparib Erlotinib TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer Recruiting
NCT03224767 Phase II Vemurafenib + Cobimetinib Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma Recruiting
NCT02036086 Phase II Vemurafenib + Cobimetinib Study of Neo-adjuvant Use of Vemurafenib Plus Cobimetinib for BRAF Mutant Melanoma With Palpable Lymph Node Metastases Recruiting
NCT02230306 Phase II Vemurafenib + Cobimetinib Phase II Study of Cobimetinib in Combination With Vemurafenib in Active Melanoma Brain Metastases Terminated
NCT02091141 Phase II Erlotinib Alectinib Vemurafenib + Cobimetinib Pertuzumab + Trastuzumab Vismodegib Atezolizumab My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors Recruiting