Eisai's Eribulin Combination Therapy Succeeds In Metastatic Breast Cancer Phase 2 Study
By C. Rajan, contributing writer
Eisai has announced that its halichondrin drug, Eribulin (Halaven) in combination with capecitabine, provided significant clinical benefit to women with metastatic breast cancer in a Phase 2 study, suggesting that this combination could be a useful adjuvant treatment option in women with early HER2-Normal/HER2 Negative and ER positive breast cancer.
In the open-label, dose-confirmation Phase 2 study, patients receiving the combination therapy showed a median progression free survival of 7.1 months. The eribulin/capecitabine combination had good safety and tolerability profiles and gave an overall response rate of 43 percent and a clinical benefit rate of 57 percent to the patients.
The company presented the results at the 2014 San Antonio Breast Cancer Symposium (SABCS).
"A major short-coming of most chemotherapy combinations in metastatic breast cancer has been that although more active, the side effects of combinations are often unacceptable. This Phase 2 study suggests that eribulin in combination with capecitabine could provide an additional treatment option for women with metastatic breast cancer that is both effective and well tolerated," comments Dr. Chris Twelves, professor at the University of Leeds and St James's Institute of Oncology.
Eribulin is also being evaluated in two additional studies, and the positive results of these trials were also presented by the company. In the first Phase 2 study assessing eribulin as a first line therapy for women with HER2 negative metastatic breast cancer, there was an improvement in quality of life. In the second Phase 2 study evaluating eribulin in combination with trastuzumab, there were improvements in pain and other symptoms.
Eribulin (Halaven) is a synthetic version of the natural product, halichondrin B, which works by inhibiting the growth phase of microtubule dynamics, thus preventing cell division. Eribulin has already been approved in Europe for treating women with locally advanced or metastatic breast cancer who have progressed after a chemotherapy regimen. The European MAA for eribulin was based on results from two global Phase 3 trials, including a multi-centre study of eribulin versus capecitabine with 1,102 patients with locally advanced or metastatic breast cancer.
Additional results from the different Phase 2 and Phase 3 trials show that the benefit of eribulin was similar for women with invasive lobular carcinoma and invasive ductal carcinoma, which are common subtypes of breast cancer.
Eisai has also reported another set of positive results this week from a Phase 2 clinical trial of its investigational dual orexin receptor antagonist (DORA) E2006 in patients with insomnia disorder.