Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Telisotuzumab Vedotin · 3 trials · 2 indications
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per BICR or death from any cause.
OS is defined as the time from randomization to the event of death from any cause.
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication (any-grade and Grade \>= 2).
Peripheral neuropathy is defined by peripheral neuropathy SMQ (narrow) (any-grade and Grade \>= 2)
Treatment-emergent ocular surface disorders defined by corneal epitheliopathy company MedDRA query (CMQ) (any-grade and Grade \>= 2).
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
OR will be defined as achieving confirmed complete response (CR) or confirmed partial response (PR) based on response evaluation criteria in solid tumors (RECIST), version 1.1.
ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Telisotuzumab Vedotin | EXPERIMENTAL | Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. |
| Docetaxel | ACTIVE_COMPARATOR | Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria. |
| Telisotuzumab Vedotin Dose A | EXPERIMENTAL | Participants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration. |
| Telisotuzumab Vedotin Dose B | EXPERIMENTAL | Participants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration. |
| Telisotuzumab Vedotin Dose C | EXPERIMENTAL | Participants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration. |
| Name | Type | Description |
|---|---|---|
| Telisotuzumab Vedotin | BIOLOGICAL | Intravenous (IV) Infusion |
| Docetaxel | DRUG | IV Infusion |
Inclusion Criteria: * Projected life expectancy of at least 12 weeks. * Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay. * Archival or fresh tumor materia...
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Telisotuzumab Vedotin is an investigational monoclonal antibody being developed for the treatment of Non-Small Cell Lung Cancer (NSCLC), specifically in adult participants with previously treated non-squamous NSCLC. It is currently being evaluated in clinical trials for this indication.
Telisotuzumab Vedotin targets MET, a receptor tyrosine kinase that is often overexpressed in certain cancers. As a MET inhibitor, it is designed to bind to MET-expressing tumor cells. This targeting mechanism is being studied in patients with previously treated c-Met+ Non-Small Cell Lung Cancer.
Telisotuzumab Vedotin is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is conducting clinical trials to evaluate the drug's safety and efficacy in Non-Small Cell Lung Cancer.
Telisotuzumab Vedotin is currently in Phase 3 clinical development. It is being studied in a Phase 3 trial comparing it to docetaxel in previously treated non-squamous Non-Small Cell Lung Cancer. The drug is investigational and has not been approved by regulatory authorities.
Telisotuzumab Vedotin is being evaluated in several clinical trials. NCT04928846 is a Phase 3 study comparing it to docetaxel in previously treated non-squamous NSCLC. NCT03539536 is a Phase 2 study in previously treated c-Met+ NSCLC. NCT06568939 is a Phase 2 pharmacokinetic study in previously treated non-squamous NSCLC.
Yes, Telisotuzumab Vedotin is also known as ABBV-399. Clinical trial records reference both names, with ABBV-399 appearing in study titles. This alternative name is used interchangeably in research and development contexts.