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Ref Type
PMID
Authors
Title Imfinzi (durvalumab) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761069
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Durvalumab Durvalumab 8 195
Tremelimumab Tremelimumab 0 28
Drug Name Trade Name Synonyms Drug Classes Drug Description
Durvalumab Imfinzi MEDI4736 Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 Imfinzi (durvalumab) is a monoclonal antibody that binds to and inhibits PD-L1 (CD274), potentially resulting in increased immune response to tumors (PMID: 25943534, PMID: 28214651). Imfinzi (durvalumab) is FDA-approved for use in patients with urothelial carcinoma and unresectable, stage III non-small cell lung cancer, in combination with Imjudo (tremelimumab) and platinum-based chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) without sensitizing EGFR or ALK mutations, in combination with platinum-based chemotherapy as neoadjuvant therapy followed by surgery and adjuvant Imfinzi (durvalumab) in patients with resectable non-small cell lung cancer, in combination with etoposide and carboplatin or cisplatin in patients with extensive stage small cell lung cancer, in combination with cisplatin and gemcitabine in patients with locally advanced or metastatic biliary tract cancer, in combination with Imjudo (tremelimumab) in adult patients with unresectable hepatocellular carcinoma, and in combination with carboplatin plus paclitaxel followed by single-agent Imfinzi (durvalumab) in adult patients with mismatch repair deficient endometrial cancer (FDA.gov).
Tremelimumab Imjudo CP-675,206|Ticilimumab|CP-675206 CTLA4 Antibody 31 Immune Checkpoint Inhibitor 149 Imjudo (tremelimumab) binds to and inhibits cytotoxic T-lymphocyte-associated protein 4 (CTLA4), thereby enhancing T-cell activation by blocking CTLA4-mediated inhibition of T-cell activation (PMID: 32620213, PMID: 32586937). Imjudo (tremelimumab) is FDA approved for use in combination with Imfinzi (durvalumab) in adult patients with unresectable hepatocellular carcinoma, and in combination with Imfinzi (durvalumab) and platinum-based chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) without sensitizing EGFR or ALK mutations (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
MLH1 negative endometrial cancer sensitive Carboplatin + Durvalumab + Paclitaxel FDA approved Actionable In a Phase III trial (DUO-E) that supported FDA approval, Imfinzi (durvalumab) plus carboplatin and paclitaxel followed by Imfinzi (durvalumab) maintenance improved progression-free survival (PFS) compared to platinum therapy + placebo and placebo maintenance (HR 0.71, p<0.003) in patients with advanced endometrial cancer, with significant PFS benefit (not reached vs 7.0 mo, HR 0.42) observed in the dMMR (as determined by the loss of MLH1, PMS2, MSH2, and MSH6 by IHC) group (PMID: 37864337; NCT04269200). detail... 37864337
MSH6 negative endometrial cancer sensitive Carboplatin + Durvalumab + Paclitaxel FDA approved Actionable In a Phase III trial (DUO-E) that supported FDA approval, Imfinzi (durvalumab) plus carboplatin and paclitaxel followed by Imfinzi (durvalumab) maintenance improved progression-free survival (PFS) compared to platinum therapy + placebo and placebo maintenance (HR 0.71, p<0.003) in patients with advanced endometrial cancer, with significant PFS benefit (not reached vs 7.0 mo, HR 0.42) observed in the dMMR (as determined by the loss of MLH1, PMS2, MSH2, and MSH6 by IHC) group (PMID: 37864337; NCT04269200). detail... 37864337