Results of a Phase 2, open-label, dose-confirmation study of eribulin in combination with capecitabine, suggests that this therapy is efficacious in women with metastatic breast cancer (overall response rate 42.9% and clinical benefit rate 57.1%), with a safety and tolerability profile consistent with previous data. In combination, eribulin and capecitabine had a median progression free survival of 7.1 months (95% CI: 4.4, 9.8).
Data from five posters presented during the 2014 San Antonio Breast Cancer Symposium (SABCS) provide further evidence on the efficacy, safety and quality of life profile of eribulin, in the treatment of patients with locally advanced or metastatic breast cancer (MBC) and data in early stage breast cancer.
A second Phase 2, multicentre, open-label study, explores the feasibility of eribulin plus capecitabine as an adjuvant therapy in women with early-stage, estrogen receptor (ER) positive breast cancer.
“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 of Clinical Cancer Pharmacology and Oncology, and Honorary Consultant in Medical Oncology at the University of Leeds and St James’s Institute of Oncology.
Two additional studies highlight quality of life outcomes for women treated with eribulin first line in monotherapy and combination with trastuzumab, respectively. The first Phase 2 study assesses eribulin as a first line therapy for women with HER2 negative metastatic breast cancer and generates a stable or improvement in quality of life scales measured by the EORTC scale, QLQ-C30. The second Phase 2 study investigates eribulin in combination with trastuzumab and shows positive improvements in pain and in arm and breast symptoms which warrant further investigation.
Additional data pooled from the pivotal Phase 3 trial EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician’s Choice Versus Eribulin), Study 301 and a single-arm Phase 2 study highlights that the benefit of eribulin was similar for women with invasive lobular carcinoma and invasive ductal carcinoma (overall survival; 13.4 vs 13.6 months; hazard ratio [HR] = 1.07; 95% CIs 0.72, 1.10). Invasive lobular carcinoma is the second most common form of breast cancer subtype and is associated with lower response rates to preoperative chemotherapy compared to invasive ductal carcinoma. Results from this study contrast with data from current chemotherapies.
First approved by the European Commission in 2011, eribulin received European Marketing Authorisation Approval (MAA) in June 2014 for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.The MAA for eribulin is based on clinical evidence from two global Phase 3 trials; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician’s Choice Versus Eribulin) and Study 301.
Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of women and their families. This passion for people is part of Eisai’s human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides.
 Source: Eisai EMEA
Date:Â December 9, 2014
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