Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bavituximab · 1 trial · 2 indications
Incidence of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.
Severity of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.
ORR was based on RECIST version 1.1 criteria for target lesions, where a patient may achieve as best overall response (BOR) either complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline summary of diameters. ORR is calculated as the number of patients achieving a CR or PR (objective response) divided by the number of efficacy patients.
| Arm | Type | Description |
|---|---|---|
| bavituximab and pembrolizumab | EXPERIMENTAL | Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks |
| Name | Type | Description |
|---|---|---|
| Bavituximab | DRUG | Bavituximab IV infusion |
| Pembrolizumab Injection | DRUG | Pembrolizumab IV Infusion |
Inclusion Criteria: * Signed written informed consent * Men and women ≥ 18 years old; ≥ 20 years old in South Korea and Taiwan * Unresectable metastatic or locally advanced gastric or GEJ adenocarcinoma * Progressed on and/or after at least 1 prior regimen for metastatic disease or achieved stable ...
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Bavituximab is an investigational antibody being studied for the treatment of gastric cancer and gastroesophageal junction cancer. It is being evaluated in combination with pembrolizumab in patients with advanced disease. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Bavituximab is a monoclonal antibody, indicated by the '-mab' suffix in its name. As an antibody-based therapy, it is designed to bind to specific targets involved in cancer progression. However, its precise molecular target has not been specified in the available clinical trial information.
Bavituximab is being developed by Merck & Company, Inc., a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with gastric cancer.
Bavituximab is currently in Phase 2 clinical development. It has completed one Phase 2 trial, which was an open-label study in patients with advanced gastric and gastroesophageal junction cancer. The drug remains investigational and has not received FDA approval.
Bavituximab has been studied in one completed clinical trial, registered as NCT04099641. This Phase 2 study was an open-label trial evaluating Bavituximab in combination with pembrolizumab in 80 patients with advanced gastric and gastroesophageal cancer. The trial was conducted in the United States, South Korea, Taiwan, and the United Kingdom.
No, Bavituximab is not the same as pembrolizumab. Bavituximab is an investigational antibody being developed by Merck, while pembrolizumab is a separate immunotherapy drug. In the clinical trial NCT04099641, Bavituximab was studied in combination with pembrolizumab to assess their combined effect in treating gastric cancer.