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AUY922 · 6 trials · 7 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 | - |
| 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 | - |
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 being studied for multiple oncology indications, including advanced HER2-positive breast cancer, advanced solid tumors, advanced gastric cancer, non-small-cell lung cancer, and relapsed or refractory multiple myeloma. It is also being evaluated in stomach and esophageal neoplasms, metastatic gastric cancer with mutated PI3KCA protein, and HER2-overexpressing tumors.
AUY922 is an HSP90 inhibitor, a class of drugs that target the heat shock protein 90 chaperone. By inhibiting HSP90, AUY922 disrupts the folding and stability of client proteins involved in cancer growth, including HER2 and PI3KCA. This mechanism is being studied across several HER2-positive and PI3KCA-mutated tumor types.
AUY922 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials of AUY922 across multiple oncology indications, including breast cancer, gastric cancer, and solid tumors.
AUY922 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, including a Phase 2 study in advanced gastric cancer. However, AUY922 is still investigational and has not been approved by regulatory authorities. It remains in active clinical development for several oncology indications.
AUY922 has been studied in several completed clinical trials, including NCT00526045, a Phase 1-2 study in advanced solid malignancies and breast cancer; NCT01084330, a Phase 2 trial in advanced gastric cancer; NCT01271920, a Phase 1 combination study with trastuzumab in HER2-positive breast cancer; and NCT01613950, a Phase 1 study combining AUY922 with BYL719 in gastric cancer.
AUY922 is also known by the generic name luminespib, though this alternative name is not provided in the available data. The drug is being developed by Novartis under the code AUY922. Readers searching for luminespib should note that it refers to the same investigational HSP90 inhibitor.