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AUY922 · 7 trials · 9 indications
The primary endpoint of the study was the investigator assessment of efficacy at 18 weeks in terms of response complete response (CR)/partial response (PR), stable disease (SD), or non clinical benefit (NCB) as assessed by response evaluation criteriain solid tumors (RECIST) version 1.0. ORR = patients with confirmed complete or partial response. Stable disease at 18 weeks = patients without response and with no assessment of progressive disease up to 18 weeks, but with an assessment of stable disease or better either within 2 weeks prior to the 18 week time point, or at the next non-missing assessment after the 18 week time point. No clinical benefit = all other patients.
To determine the maximum tolerated dose (MTD) and/or Recommended dose for expansion (RDE) and schedule of BYL719 and AUY922 when used as a combination in patients with advanced or metastatic gastric cancer carrying a molecular alteration of PIK3CA and/or an amplification of HER2. 1 cycle = 28days
| Arm | Type | Description |
|---|---|---|
| EGFR mutant patients | EXPERIMENTAL | Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m\^2 weekly infusions. |
| Kras mutant patients | EXPERIMENTAL | Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m\^2 weekly infusions. |
| EGFR and Kras wild type patients | EXPERIMENTAL | Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m\^2 weekly infusions. |
| Patients with EML4-ALK translocation | EXPERIMENTAL | Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m\^2 weekly infusions. |
| Modified EGFR mutant patients | EXPERIMENTAL | The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m\^2 weekly infusions. |
| AUY922 | EXPERIMENTAL | - |
| Docetaxel or Irinotecan | ACTIVE_COMPARATOR | - |
| BYL719 + AUY922 | EXPERIMENTAL | Dose finding study to estimate the maximum tolerated dose(s) (MTD) and/or recommended dose(s) for safety expansion (RDE) followed by an expansion phase to further assess the safety and preliminary activity of the combination. BYL719 tablets will be administered orally on a daily schedule (q.d.). a b.i.d. regimen may be explored. AUY922 will be administered by IV infusion once per week. |
| AUY922 + Trastuzumab | EXPERIMENTAL | - |
| Single Agent AUY922 | EXPERIMENTAL | - |
| AUY922 + Bortezomib | EXPERIMENTAL | - |
| AUY922 + Bortezomib + Dexamethasone | EXPERIMENTAL | - |
| Escalation | EXPERIMENTAL | - |
| HER2 Positive | EXPERIMENTAL | - |
| ER+ breast cancer | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AUY922 | DRUG | AUY922 was supplied in individual 10 mL amber colored glass ampoules containing 10 mL of a 5 mg/mL active drug substance in 5% aqueous glucose solution. AUY922 was administered intravenously (i.v.) weekly at 70 mg/m2. |
| Docetaxel | DRUG | Docetaxel 75mg/m2 |
| Irinotecan | DRUG | Iriniotecan 350mg/m2 |
| BYL719 | DRUG | BYL719 is an oral α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor. |
| Trastuzumab | DRUG | - |
| Bortezomib | DRUG | - |
| Dexamethasone | DRUG | - |
| AUY922 2 mg/m2 | DRUG | - |
Inclusion Criteria: * Patients with histologically or cytologically confirmed advanced (stage IIIB or stage IV) NSCLC who have received at least two prior lines of treatment. Patients who, in the investigators opinion, are deemed unsuitable for the standard 2nd line chemotherapy will be eligible fo...
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AUY922 is an investigational small molecule studied in oncology for advanced solid tumors and blood cancers. Its clinical program covered advanced gastric cancer, advanced HER2-positive breast cancer, non-small-cell lung cancer, advanced solid tumors, breast cancer, and relapsed or refractory multiple myeloma. It is not an approved therapy and remains in clinical development.
AUY922 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical trials evaluating the compound across advanced solid tumors, gastric cancer, HER2-positive breast cancer, and non-small-cell lung cancer.
AUY922 has been studied in Phase 2 clinical development. The Phase 2 trial NCT01124864 enrolled 153 patients with non-small-cell lung cancer who had received two prior lines of chemotherapy. Other studies of AUY922 were Phase 1 dose-escalation and combination trials, and all have completed.
AUY922 has completed four registered trials. NCT01124864 was a Phase 2 study in non-small-cell lung cancer with 153 patients. NCT01613950 tested AUY922 with BYL719 in advanced gastric cancer, NCT01271920 combined it with trastuzumab in HER2-positive breast cancer, and NCT01132625 was a dose-escalation study in advanced solid tumors in Japan.
No. AUY922 is an investigational agent and has not been approved for any indication. All of its registered trials, including the Phase 2 non-small-cell lung cancer study NCT01124864 and the Phase 1 combination studies, are listed as completed, and the compound remains in clinical development.