Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gimistotug · 1 trial · 1 indication
Overall response rate (ORR) is defined as the percentage of participants with best overall response (BOR) of a confirmed complete response (CR) or partial response (PR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1. CR is defined as: * Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. * Disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes must be nonpathological in size (\< 10 mm short axis). * No new lesions. PR is defined as: * At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * Non-progressive disease with regard to non-target lesions, persistence of 1 or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. * No new lesions.
| Arm | Type | Description |
|---|---|---|
| Gimistotug + Docetaxel | EXPERIMENTAL | Participants received gimistotug and docetaxel 75 mg/m\^2 both by intravenous infusion once every 3 weeks until disease progression, intolerable toxicity, withdrawal of informed consent, or other discontinuation criterion were met. |
| Gimistotug + BGB-15025 | EXPERIMENTAL | Participants received gimistotug by intravenous infusion once every 3 weeks and BGB-15025 orally once daily during each 3-week cycle until disease progression, intolerable toxicity, withdrawal of informed consent, or other discontinuation criterion were met. |
| Name | Type | Description |
|---|---|---|
| Gimistotug | DRUG | Administered intravenously |
| Docetaxel | DRUG | 75 milligrams per square meter (mg/m\^2) administered intravenously |
| BGB-15025 | DRUG | Administered orally |
Inclusion Criteria: * Advanced or metastatic NSCLC (nonsquamous or squamous) that is histologically or cytologically confirmed * Participants who have received no more than 2 lines of prior systemic therapies which must include anti-programmed cell death protein ligand-1 (anti-PD-(L)1) treatment an...
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Gimistotug is an investigational small molecule being studied for the treatment of Non-Small Cell Lung Cancer (NSCLC). It is currently in Phase 2 clinical development and has been evaluated in a completed clinical trial involving 35 participants.
Gimistotug is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ONC. The company is conducting clinical research on this investigational drug for Non-Small Cell Lung Cancer.
Gimistotug is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for treating Non-Small Cell Lung Cancer.
Gimistotug has been studied in a Phase 2 clinical trial registered as NCT06029127, titled 'A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer.' This trial was completed and enrolled 35 participants in China and South Korea.
Yes, Gimistotug is also known as BGB-A445. The clinical trial NCT06029127 refers to the drug as Gimistotug (BGB-A445), indicating that these names are used interchangeably for the same investigational drug being developed for Non-Small Cell Lung Cancer.