Eisai Europe Ltd and MedSIR have announced a new study investigating Halaven ® (eribulin) treatment efficacy in metastatic breast cancer (MBC).
The REVERT study will investigate the clinical activity of Halaven® (eribulin) in MBC and will investigate the efficacy of a combined endocrine-chemotherapy therapeutic approach in the condition.
MBC currently remains incurable for the majority of those affected, with a five-year survival rate of just 25%. For the last decade, aromatase inhibitors (a type of endocrine therapy) have been shown to be efficacious for post-menopausal ER-positive/HER2-negative MBC patients. Clinical trial data showed that they have a good overall response rate (ORR) and can increase progression-free survival (PFS). However, the majority of these patients eventually experience resistance to endocrine therapies, speeding up the progression of metastasis.
The primary endpoint of the REVERT study is the ORR in patients treated with the combination of eribulin and endocrine therapy, defined as the proportion of patients with complete response or partial response based on the local investigator’s assessment, according to the Response Evaluation Criteria in Solid Tumours (RECIST V.1.11) criteria. The secondary endpoints of the study include investigating progression-free survival (PFS), duration of response, clinical benefit rate, overall survival (OS), and the change in maximum tumour shrinkage in response to eribulin in monotherapy and combined with endocrine therapy as well as ORR in response to eribulin monotherapy only.
Eribulin is a single chemotherapeutic agent, currently indicated for the treatment of adult patients with locally advanced breast cancer or MBC 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. Working as a microtubule-dynamics inhibitor, which binds to a limited number of high affinity sites on the growing positive ends of microtubules to inhibit growth, eribulin is the only single cytotoxic chemotherapeutic agent that has demonstrated a significant prolongation in OS in MBC patients previously treated with an anthracycline/taxane.
The most reported adverse events related to eribulin (reported in ≥10% of patients) include neutropenia, leukopenia, anaemia, decreased appetite, peripheral neuropathy, headache, dyspnoea, cough, nausea, constipation, diarrhoea, vomiting, alopecia, arthralgia and myalgia, back pain, pain in extremity, fatigue, pyrexia and weight loss.
The first data readout from the REVERT study investigating Halaven ® (eribulin) treatment efficacy in metastatic breast cancer is estimated to be in late 2021.