Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eribulin · 1 trial · 1 indication
ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent imaging review (IIR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) calculated by Clopper-Pearson method. As planned, data up to the primary completion date only were analyzed.
| Arm | Type | Description |
|---|---|---|
| Eribulin Mesylate + Pembrolizumab | EXPERIMENTAL | Participants with mTNBC previously treated with 0 (stratum 1) or 1 to 2 (stratum 2) lines of systemic anticancer therapy (cytotoxic or targeted anticancer agents) in the metastatic setting. |
| Name | Type | Description |
|---|---|---|
| Eribulin Mesylate | DRUG | Eribulin Mesylate will be administered as a 1.4 milligram per square meter (mg/m\^2) IV (intravenous) infusion on Day 1 and Day 8 of each 21-day cycle in the presence of clinical benefit until intercurrent illness, unacceptable toxicity, or disease progression occurs, or until the participant withdraws consent. |
| Pembrolizumab | DRUG | Pembrolizumab will be administered as a 200 milligram (mg) IV infusion on Day 1 of each 21-day cycle in the presence of clinical benefit until intercurrent illness, unacceptable toxicity, or disease progression occurs, or until the participant withdraws consent. |
Inclusion Criteria: 1. Females or males, aged \>=18 years at the time of signing the informed consent form (ICF). 2. mTNBC (confirmed from most recent tissue sample) meeting the following criteria: 1. Estrogen receptor (ER) and progesterone receptor negative (a tumor is ER and/or progesterone r...
Eribulin is a small molecule being studied for the treatment of breast neoplasms, specifically in combination with pembrolizumab for participants with metastatic triple-negative breast cancer (mTNBC). It is an investigational oncology drug currently in Phase 1 clinical development.
Eribulin is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's efficacy and safety in oncology indications.
Eribulin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, with no active trials currently ongoing.
Eribulin has been studied in one completed clinical trial, NCT02513472, which evaluated the efficacy and safety of eribulin mesylate in combination with pembrolizumab in participants with metastatic triple-negative breast cancer. The trial enrolled 258 participants in the United States.
Eribulin is the active pharmaceutical ingredient, and eribulin mesylate is the salt form used in the clinical trial. The trial NCT02513472 specifically tested eribulin mesylate in combination with pembrolizumab for metastatic triple-negative breast cancer.