Eribulin mesylate, a synthetic analogue of halichondrin B, a substance derived from a marine sponge, inhibits the polymerization of tubulin and microtubules. Phase II studies observed a significant level of activity in heavily pretreated patients with advanced breast cancer.
Preliminary results of the phase III EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) trial were presented at the 2010 American Society of Clinical Oncology meeting [59]. In this trial, 762 heavily pretreated patients were randomly assigned to either eribulin (1.4 mg/m2 days 1 and 8 every 21 days) or other treatment of the physician’s and patient’s choice. Treatment with eribulin compared to alternative therapy significantly improved median overall survival (the primary endpoint, 13.1 versus 10.7 months). The primary toxicity with eribulin was neutropenia, with grade 3 and 4 neutropenia in 45 percent of patients, and grade 3 and 4 febrile neutropenia in 4 percent.
In November 2010, based upon results from the phase III EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) trial, the US FDA approved eribulin for treatment of metastatic breast cancer in patients who have previously received an anthracycline and taxane in the adjuvant or metastatic setting and at least two prior metastatic chemotherapy regimens.
Source:
- Cortes J, Vahdat L, Blum JL, et al. Phase II study of the halichondrin B analog eribulin mesylate in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline, a taxane, and capecitabine. J Clin Oncol 2010; 28:3922.
- Twelves, C, Loesch, JL, Blum, LT, et al. A phase III study (EMBRACE) of eribulin mesylate versus treatment of physician's choice in patients with locally recurrent or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2010; 28:18s.
- Vahdat LT, Pruitt B, Fabian CJ, et al. Phase II study of eribulin mesylate, a halichondrin B analog, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2009; 27:2954.