GHP Q2 2019

26 GHP / Q2 2019 , REVERT study is amulticenter, randomised, phase II trial evaluating the efficacy of Halaven® (eribulin) monotherapy and eribulin plus endocrine therapy in locally-recurrent or metastatic breast cancer patients (MBC) after progression on endocrine therapy. Eisai and MedSIR Announce Initiation Of New Study Investigating Halaven® (Eribulin) Treatment Efficacy In Metastatic Breast Cancer Eisai Europe Ltd and MedSIR today announced the initiation of the REVERT study to investigate the clinical activity of Halaven® (eribulin) in MBC.1 The trial aims to investigate the efficacy of a combined endocrine-chemotherapy therapeutic approach in MBC. MBC currently remains incurable for the majority of those affected, with a five-year survival rate of just 25 percent. 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 overall response rate (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. “Endocrine resistance is one of the most important clinical issues within the treatment landscape of metastatic breast cancer,” commented Dr Javier Cortés, Head of Breast Cancer Programme at the IOB Institute of Oncology in Madrid & Barcelona, Spain. “The REVERT study will look at the possibility of a combined endocrine- chemotherapy therapeutic approach, which could benefit a significant number of patients across Europe.” “The REVERT Study has the potential to unlock some interesting properties that we did not previously know about eribulin,” said Maria Campos, Strategy Director in MedSIR. “We hope that the findings from this trial will ultimately benefit many patients across Europe who currently are faced with such treatment challenges.” 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. [6] 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.6 The first data readout from the REVERT study is estimated to be in late 2021