Missing content? – Request curation!
Request curation for specific Genes, Variants, or PubMed publications.
Have questions, comments, or suggestions? - Let us know!
Email us at : ckbsupport@genomenon.com
Ref Type | |||||||||||||
PMID | |||||||||||||
Authors | |||||||||||||
Title | Imfinzi (durvalumab) FDA Drug Label | ||||||||||||
|
|||||||||||||
URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761069 | ||||||||||||
Abstract Text |
Molecular Profile | Treatment Approach |
---|
Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
---|
Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
---|---|---|---|
Durvalumab | Durvalumab | 8 | 196 |
Tremelimumab | Tremelimumab | 0 | 29 |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Durvalumab | Imfinzi | MEDI4736 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 | 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, unresectable, stage III non-small cell lung cancer, and limited-stage 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 |