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|Title||Tecentriq (atezolizumab) FDA Drug Label|
|Molecular Profile||Treatment Approach|
|Gene Name||Source||Synonyms||Protein Domains||Gene Description||Gene Role|
|Therapy Name||Drugs||Efficacy Evidence||Clinical Trials|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Atezolizumab||Tecentriq||RG7446|MPDL3280A||Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 63||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 advanced or metastatic urothelial carcinoma not eligible for cisplatin-containing chemotherapy, in advanced or metastatic urothelial carcinoma not eligible for chemotherapy or progressed on platinum-based 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, 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 paclitaxel protein-bound in advanced or metastatic triple-negative breast cancer expressing PD-L1, 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 cobimetinib and vemurafenib in BRAF V600-mutated melanoma (FDA.gov).|
|Gene||Variant||Impact||Protein Effect||Variant Description||Associated with drug Resistance|
|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...|
|Unknown unknown||hepatocellular carcinoma||not applicable||Atezolizumab + Bevacizumab||FDA approved||Actionable||In a Phase III trial (IMbrave150) that supported FDA approval, Tecentriq (atezolizumab) and Avastin (bevacizumab) combination therapy improved survival compared to Nexavar (sorafenib) (HR for death=0.58, p<0.001) in patients with unresectable hepatocellular carcinoma, with superior overall survival at 12 months (67.2% vs 54.6%) and prolonged median progression-free survival (6.8 vs 4.3 months, HR=0.59, p<0.001) (PMID: 32402160; NCT03434379).||detail... 32402160|
|Unknown unknown||transitional cell carcinoma||not applicable||Atezolizumab||FDA approved||Actionable||In a Phase II trial that supported FDA approval, treatment with Tecentriq (atezolizumab) in advanced urothelial carcinoma patients resulted in an objective response rate of 15% (45/310) in all patients, and 26% (26/100) in patients with immune cell PD-L1 expression greater than or equal to 5%, and resulted in an overall survival of 8.6 mo in patients receiving treatment post-progression compared to 1.2 mo in patients receiving no treatment post-progression (PMID: 26952546, PMID: 28950298; NCT02108652).||26952546 28950298 detail...|
|Unknown unknown||lung non-small cell carcinoma||not applicable||Atezolizumab||FDA approved||Actionable||In a Phase III trial (OAK) that supported FDA approval, treatment with Tecentriq (atezolizumab) resulted in an improved median overall survival compared to Taxotere (docetaxel) (13.8 vs 9.6 months, HR=0.73, p=0.0003) in patients with previously treated non-small cell lung cancer (PMID: 27979383; NCT02008227).||detail... 27979383|
|Unknown unknown||lung small cell carcinoma||not applicable||Atezolizumab + Carboplatin + Etoposide||FDA approved||Actionable||In a Phase III trial (IMpower133) that supported FDA approval, Tecentriq (atezolizumab) in combination with Paraplatin (carboplatin) and Vepesid (etoposide) resulted in significantly improved median overall survival (12.3 vs 10.3 months, HR=0.70, p=0.007) and median progression-free survival (5.2 vs 4.3 months, HR=0.77, p=0.02) compared to placebo in patients with untreated extensive-stage small-cell lung cancer (PMID: 30280641; NCT02763579).||detail... 30280641|