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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 147 PD-L1/PD-1 antibody 117 | 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, in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) in unresectable or metastatic BRAF V600-mutated melanoma, and in pediatric and adult patients with unresectable or metastatic alveolar soft part sarcoma (FDA.gov). |
| Cobimetinib | Cotellic | GDC-0973 | MEK inhibitor (Pan) 24 MEK1 Inhibitor 26 MEK2 Inhibitor 24 | 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) 27 | 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 | 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 | 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 | skin melanoma | sensitive | Atezolizumab + Cobimetinib + Vemurafenib | Guideline | Actionable | Zelboraf (vemurafenib) plus Cotellic (cobimetinib) in combination with an immune checkpoint inhibitor, such as Tecentriq (atezolizumab), is included in guidelines as second-line or subsequent therapy (category 2A) for patients with metastatic or unresectable cutaneous melanoma harboring a BRAF V600 mutation (NCCN.org). | detail... |
| BRAF V600K | skin melanoma | sensitive | Atezolizumab + Cobimetinib + Vemurafenib | Guideline | Actionable | Zelboraf (vemurafenib) plus Cotellic (cobimetinib) in combination with an immune checkpoint inhibitor, such as Tecentriq (atezolizumab), is included in guidelines as second-line or subsequent therapy (category 2A) for patients with metastatic or unresectable cutaneous melanoma harboring a BRAF V600 mutation, such as BRAF V600K (NCCN.org). | detail... |
| BRAF V600E | skin melanoma | sensitive | Atezolizumab + Cobimetinib + Vemurafenib | Guideline | Actionable | Zelboraf (vemurafenib) plus Cotellic (cobimetinib) in combination with an immune checkpoint inhibitor, such as Tecentriq (atezolizumab), is included in guidelines as second-line or subsequent therapy (category 2A) for patients with metastatic or unresectable cutaneous melanoma harboring a BRAF V600 mutation, such as BRAF V600E (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03554083 | Phase I | Atezolizumab + Cobimetinib Atezolizumab + Cobimetinib + Vemurafenib | Vemurafenib, Cobimetinib, and Atezolizumab in Treating Participants With High-Risk Stage III Melanoma | Recruiting | USA | 0 |
| 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 |
| 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 | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 8 |
| NCT04722575 | Phase II | Atezolizumab + Cobimetinib + Vemurafenib Atezolizumab + Cobimetinib | Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma (NEO-TIM) | Active, not recruiting | ITA | 0 |
| 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 | Active, not recruiting | USA | 0 |
| NCT03178552 | Phase II | Entrectinib Carboplatin + Cisplatin + Gemcitabine Atezolizumab Carboplatin + Cisplatin + Pemetrexed Disodium Atezolizumab + Cobimetinib + Vemurafenib Alectinib | A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (B-FAST) | Recruiting | USA | NZL | NLD | ITA | FRA | ESP | DEU | CAN | BEL | AUS | 20 |
| 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 |
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