Therapy Detail

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Therapy Name Atezolizumab + Cobimetinib + Vemurafenib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Atezolizumab Tecentriq RG7446|MPDL3280A Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 95 Tecentriq (atezolizumab) is a monoclonal antibody against PD-L1 (CD274), preventing activation of its receptor, potentially enhancing T-cell-mediated immune response to neoplasms and inhibiting T-cell inactivation (PMID: 29449897). Tecentriq (atezolizumab) is FDA approved for use in PD-L1 positive (IC >/= 5%) advanced or metastatic urothelial carcinoma not eligible for cisplatin-containing chemotherapy, in advanced or metastatic urothelial carcinoma not eligible for chemotherapy, in metastatic non-small cell lung cancer (NSCLC) progressed on platinum-containing therapy, as first-line therapy in metastatic NSCLC with high PD-L1 expression (TC>/=50% or IC>/=10%) and without EGFR or ALK alterations, for adjuvant treatment in patients with PD-L1-positive (>=1% tumor cell expression) NSCLC, in combination with bevacizumab, paclitaxel, and carboplatin as first-line therapy for non-squamous NSCLC with no EGFR or ALK aberrations, in combination with paclitaxel protein-bound and carboplatin in metastatic non-squamous NSCLC with no EGFR or ALK aberrations, in combination with carboplatin and etoposide in extensive-stage small cell lung cancer, in combination with bevacizumab in hepatocellular carcinoma without prior systemic therapy, and in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) in unresectable or metastatic BRAF V600-mutated melanoma (FDA.gov).
Cobimetinib Cotellic GDC-0973 MEK inhibitor (Pan) 23 MEK1 Inhibitor 22 MEK2 Inhibitor 20 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 use in combination with Zelboraf (vemurafenib) in melanoma patients harboring BRAF V600E or V600K (FDA.gov).
Vemurafenib Zelboraf RO5185426|PLX4032 RAF Inhibitor (Pan) 23 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF V600X melanoma sensitive Atezolizumab + Cobimetinib + Vemurafenib Phase Ib/II Actionable In a Phase Ib trial, the combination therapy of Tecentriq (atezolizumab), Zelboraf (vemurafenib), and Cotellic (cobimetinib) in patients with metastatic melanoma harboring a BRAF V600 mutation resulted in a best objective response rate of 71.8% (28/39), with a complete response in 20.5% (8/39), a median progression-free survival of 12.9 months, a median overall survival not yet reached, and median duration of confirmed response of 17.4 months (PMID: 31171876; NCT01656642). detail... 31171876
BRAF V600X melanoma sensitive Atezolizumab + Cobimetinib + Vemurafenib FDA approved Actionable In a Phase III trial (IMspire150) that supported FDA approval, addition of Tecentriq (atezolizumab) to Zelboraf (vemurafenib) and Cotellic (cobimetinib) combination therapy significantly improved progression-free survival (15.1 vs 10.6 months, HR=0.78, p=0.025) compared to control in patients with advanced or metastatic melanoma harboring BRAF V600 mutations (PMID: 32534646; NCT02908672). 32534646 detail...
BRAF V600X skin melanoma sensitive Atezolizumab + Cobimetinib + Vemurafenib Guideline Actionable Tecentriq (atezolizumab), Zelboraf (vemurafenib), and Cotellic (cobimetinib) combination therapy is included in guidelines as a preferred first-line 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
NCT01656642 Phase I Atezolizumab + Cobimetinib + Vemurafenib Atezolizumab + Vemurafenib A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma Completed USA 0
NCT04551521 Phase II Atezolizumab Atezolizumab + Ipatasertib Atezolizumab + Pertuzumab + Trastuzumab Atezolizumab + Cobimetinib Alectinib Atezolizumab + Cobimetinib + Vemurafenib CRAFT: The NCT-PMO-1602 Phase II Trial Recruiting DEU 0
NCT03554083 Phase I Atezolizumab + Cobimetinib Atezolizumab + Cobimetinib + Vemurafenib Vemurafenib, Cobimetinib, and Atezolizumab in Treating Participants With High-Risk Stage III Melanoma Recruiting USA 0
NCT02908672 Phase III Cobimetinib + Vemurafenib Atezolizumab + Cobimetinib + Vemurafenib 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 USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 12
NCT04722575 Phase II Atezolizumab + Cobimetinib + Vemurafenib Atezolizumab + Cobimetinib Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma (NEO-TIM) Recruiting ITA 0
NCT03178552 Phase II Entrectinib Carboplatin + Cisplatin + Gemcitabine Atezolizumab Carboplatin + Cisplatin + Pemetrexed Disodium Atezolizumab + Cobimetinib + Vemurafenib Alectinib A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (B-FAST) Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 22
NCT03181100 Phase II Atezolizumab + Cobimetinib Atezolizumab + Bevacizumab Atezolizumab + Nab-paclitaxel Atezolizumab + Cobimetinib + Vemurafenib Atezolizumab + Paclitaxel Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer Recruiting USA 0


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