The MERIBEL Trial
First-line Eribulin Therapy for Taxane-Pretreated HER2-Negative Metastatic Breast Cancer
Since its foundation in 2012, MedSIR has embarked on a journey to improve the lives of cancer patients by designing and developing innovative clinical trials in Medical Oncology. One of our initial projects was the MedSIR-designed and MedSIR-sponsored MERIBEL study and we are very pleased to announce that the results of this study have just been published in the latest edition of Clinical Breast Cancer.
The MERIBEL trial is a good example of how MedSIR seeks -in a very patient-focused manner- to find new niches for established drugs, like eribulin, outside of their current indications. Here, we look to assess the efficacy and safety of first-line single-agent eribulin in patients with aggressive taxane-pretreated Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic breast cancer (MBC) with a short disease-free interval (DFI).
Eribulin is a non-taxane microtubule dynamic inhibitor that has demonstrated significant clinical benefit through two large, randomized, comparative phase III studies: the EMBRACE trial and the 301 Study. Prior to the MERIBEL study, eribulin had been approved as monotherapy for the treatment of patients with MBC who have previously received at least 1 and up to 5 prior chemotherapeutic regimens, including a taxane and an anthracycline.
In patients with HER2-negative MBC, taxanes and anthracyclines have been the standard front-line chemotherapy. However, these agents have been frequently used as neoadjuvant or adjuvant therapy. Consequently, the number of patients previously exposed to taxanes and anthracyclines by the time they have developed MBC has been increasing.
A short DFI and previous exposure to a taxane-based regimen in the neoadjuvant or adjuvant setting have been associated with worse overall survival (OS) for patients receiving first-line chemotherapy for HER2-negative MBC. Thus, new therapeutic options are urgently needed for this poor-prognosis population.
Since September 2013, 53 patients were enrolled in 12 sites in Spain and Portugal. The findings demonstrated that the median time to progression was 4.1 months, and the clinical benefit rate was 26.4%. Moreover, eribulin monotherapy demonstrated a manageable toxicity profile.
Based on these results, we conclude that eribulin monotherapy has substantial antitumor activity and an acceptable safety profile as first-line therapy for patients with aggressive taxane-pretreated HER2-negative MBC, with a short DFI after completing adjuvant taxane-based chemotherapy.
It was a long journey with many challenges, but the perseverance and effort of the site investigators and collaborators from Spain and Portugal –as well as the MedSIR Operations team– were key in delivering the much-anticipated data. On behalf of MedSIR, we would like to thank all the patients who have participated in the MERIBEL trial as well as their families and support groups.
Also, MedSIR is currently evaluating eribulin in two other MedSIR-designed trials in patients with Hormone Receptor-positive/HER2-negative, unresectable locally advanced or MBC: (1) The KELLY trial assessing efficacy of eribulin in combination with pembrolizumab in patients who have previously received an anthracycline and a taxane; (2) The REVERT trial exploring the efficacy of eribulin in combination with hormone therapy in patients who had previously shown progression while on an aromatase inhibitor-containing regimen.