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 16 | 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 147 PD-L1/PD-1 antibody 117 | 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 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, and in combination with Imjudo (tremelimumab) in adult patients with unresectable hepatocellular carcinoma (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 |
| ATM inact mut | lung non-small cell carcinoma | predicted - sensitive | Ceralasertib + Durvalumab | Phase II | Actionable | In a Phase II trial (HUDSON), treatment with the combination of Imfinzi (durvalumab) and Ceralasertib (AZD6738) demonstrated efficacy in patients with advanced non-small cell lung cancer harboring inactivating ATM mutations, with an objective response rate of 26.1% (6/23, all partial responses), a median progression-free survival of 8.4 months, and a median overall survival of 22.8 months (PMID: 38351187; NCT03334617). | 38351187 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| NCT03334617 | Phase II | Danvatirsen + 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) | Active, not recruiting | USA | FRA | ESP | DEU | CAN | AUT | 2 |
| 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 | GBR | FRA | ESP | CAN | BEL | AUS | 2 |
| NCT05450692 | Phase III | Docetaxel Ceralasertib + Durvalumab | A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy (LATIFY) | Recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 13 |
| 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) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 2 |
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