Therapy Detail
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| Therapy Name | Durvalumab + MEDI0680 |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Durvalumab | Imfinzi | MEDI4736 | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 134 | 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 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, in combination with carboplatin plus paclitaxel followed by single-agent Imfinzi (durvalumab) in adult patients with mismatch repair deficient endometrial cancer, in combination with cisplatin plus gemcitabine followed by single-agent Imfinzi (durvalumab) in adult patients with muscle invasive bladder cancer (FDA.gov). |
| MEDI0680 | AMP-514|AMP514|MEDI-0680 | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 134 | MEDI0680 (AMP-514) is a monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (PMID: 31439037). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| CD274 pos MSH2 E226* MSH2 E580* MSH2 A913fs MSH2 neg MSH6 R361H MSH6 neg | renal pelvis transitional cell carcinoma | predicted - sensitive | Durvalumab + MEDI0680 | Case Reports/Case Series | Actionable | In a Phase I trial, treatment with the combination of Imfinzi (durvalumab) and MEDI0680 (AMP-514) resulted in a complete response ongoing for at least 11 months in a patient with metastatic MSH2 and MSH6-negative, CD274 (PD-L1)-positive renal pelvis urothelial carcinoma harboring MSH2 A913fs, E226*, and E580*, and MSH6 R361H (PMID: 26674132; NCT02118337). | 26674132 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02118337 | Phase I | Durvalumab + MEDI0680 | A Phase 1, Open-label Study to Evaluate the Safety and Tolerability of MEDI0680 (AMP-514) in Combination With MEDI4736 in Subjects With Advanced Malignancies | Completed | USA | NLD | GBR | FRA | CAN | AUS | 0 |
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