Therapy Detail
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| Therapy Name | Vistusertib |
| Synonyms | |
| Therapy Description |
Vistusertib (AZD2014) is an ATP-competitive inhibitor of mTOR, which may result in tumor growth inhibition (PMID: 23375793, PMID: 31707687). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Vistusertib | AZD2014|AZD-2014 | mTOR Inhibitor 51 | Vistusertib (AZD2014) is an ATP-competitive inhibitor of mTOR, which may result in tumor growth inhibition (PMID: 23375793, PMID: 31707687). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| STK11 loss | lung non-small cell carcinoma | no benefit | Vistusertib | Clinical Study - Cohort | Actionable | In a Phase II trial (NLMT), Vistusertib (AZD2014) treatment resulted in an observed objective response rate (ORR) of 0% (0/17), durable clinical benefit rate (DCBR) of 12% (2/17), and medial progression-free survival (PFS) of 2.3 months in patients with non-small cell lung cancer harboring STK11 loss, with Bayesian posterior probability for OR and DCBR of <0.01 and 0.06, respectively, thus the cohort was closed due to futility (PMID: 32669708, NCT02664935). | 32669708 |
| STK11 inact mut | lung non-small cell carcinoma | no benefit | Vistusertib | Phase II | Actionable | In a Phase II trial, Vistusertib (AZD2014) did not result in a clinically relevant objective response rate (OR) or durable clinical benefit (DCB) in STK11-deficient non-small cell lung cancer patients, with an OR of 9.8% (2/26, 2 partial responses) and DCB of 24.4% (6/26) in those with KRAS co-mutations, and OR of 0% (0/17) and DCB of 14.6% (2/17) in KRAS wild-type patients, and led to feedback reactivation of Akt signaling in STK11-deficient lung cancer cell lines in culture (PMID: 40069402; NCT02664935). | 40069402 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02813135 | Phase Ib/II | Lirilumab + Nivolumab Irinotecan + Olaparib Ceralasertib + Olaparib Futibatinib Vistusertib Cyclophosphamide + Nivolumab Ribociclib + Temozolomide + Topotecan Temozolomide + Topotecan + Vistusertib Adavosertib + Carboplatin CYC065 + Temozolomide CYC065 + Cytarabine Capmatinib + Everolimus Enasidenib Everolimus + Ribociclib Selumetinib + Vistusertib Avelumab + Peposertib + Temozolomide Capivasertib + Vinorelbine Dexamethasone + Everolimus + Ribociclib | European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors (ESMART) | Recruiting | NLD | ITA | GBR | FRA | ESP | DNK | 0 |
| NCT02403895 | Phase II | Vistusertib Paclitaxel | AZD2014 and Weekly Paclitaxel in Squamous NSCLC | Terminated | USA | ESP | DEU | 0 |
| NCT02619864 | Phase Ib/II | Vistusertib | mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Previously Treated Glioblastoma Multiforme | Completed | CAN | 0 |
| NCT02831257 | Phase II | Vistusertib | AZD2014 In NF2 Patients With Progressive or Symptomatic Meningiomas | Completed | USA | 0 |
| NCT03071874 | Phase II | Vistusertib | Phase II Study Of Vistusertib (AZD2014) For Recurrent Grade II-III Meningiomas | Unknown status | USA | 0 |
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