Therapy Detail
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| Therapy Name | Ceralasertib + Durvalumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ceralasertib | AZD6738|AZD-6738 | ATR Inhibitor 14 | Ceralasertib (AZD6738) is an inhibitor of ATR, which may enhance the sensitivity of chemotherapeutic agents, potentially resulting in tumor regression (PMID: 26517239, PMID: 31836456). | |
| Durvalumab | Imfinzi | MEDI4736 | Immune Checkpoint Inhibitor 148 PD-L1/PD-1 antibody 93 | 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 etoposide and carboplatin or cisplatin in patients with extensive stage small cell lung cancer, and in combination with cisplatin and gemcitabine in patients with locally advanced or metastatic biliary tract cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ATM negative | stomach cancer | predicted - sensitive | Ceralasertib + Durvalumab | Phase II | Actionable | In a Phase II trial, Ceralasertib (AZD6738) and Imfinzi (durvalumab) combination therapy resulted in an overall response rate of 22.6% (7/31, all partial responses), disease control rate of 58.1%, and median progression-free survival (mPFS) of 3.0 mo in advanced gastric cancer patients, with improved mPFS (5.60 vs 1.65 mo; HR 0.13, p<0.001) in patients with ATM protein loss and/or homologous repair deficiency (HRD) compared to those with intact ATM expression or HR proficiency (PMID: 35790315; NCT03780608). | 35790315 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02264678 | Phase Ib/II | Ceralasertib Carboplatin + Ceralasertib Ceralasertib + Durvalumab Ceralasertib + Olaparib | Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents | Recruiting | USA | FRA | 2 |
| NCT03833440 | Phase II | Ceralasertib + Durvalumab Durvalumab + Oleclumab Docetaxel Durvalumab + Monalizumab | Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance (PIONeeR) | Recruiting | FRA | 0 |
| NCT05061134 | Phase II | Ceralasertib + Durvalumab Ceralasertib | A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition (MONETTE) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 4 |
| NCT03334617 | Phase II | AZD9150 + Durvalumab Durvalumab + Olaparib Cediranib + Durvalumab Durvalumab + Vistusertib Durvalumab + Trastuzumab deruxtecan Ceralasertib + Durvalumab | Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON) | Recruiting | USA | FRA | ESP | DEU | CAN | AUT | 2 |
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