Eisai Europe has partnered with MedSIR to assess Halaven (eribulin) in the REVERT clinical study, which involves metastatic breast cancer patients.
The trial is designed to evaluate the clinical activity of the therapeutic as part of a combined endocrine-chemotherapy approach.
Halaven is a chemotherapeutic agent that acts as a microtubule-dynamics inhibitor. The compound binds to limited high-affinity sites on microtubules to prevent growth. It is indicated for adults with locally advanced or metastatic breast cancer that have seen progress following at least one chemotherapeutic regimen for advanced disease.
Previous therapies should have included an anthracycline and a taxane in the adjuvant or metastatic setting, except in cases where the patient was not suitable for these treatments.
The primary endpoint of the REVERT study is overall response rate (ORR) in patients treated with the combination of eribulin and endocrine therapy.
ORR will be defined as the proportion of patients with complete response (CR) or partial response (PR), which will be determined using the Response Evaluation Criteria in Solid Tumours (RECIST V.1.11).
The trial will assess secondary endpoints, including progression-free survival (PFS), duration of response, clinical benefit rate, overall survival (OS) and change in maximum tumour shrinkage with eribulin monotherapy and in combination with endocrine therapy.
It will also track the objective response rate (ORR) to eribulin monotherapy. The first data readout from the study is expected to take place in late-2021.
MedSIR strategy director Maria Campos said: “The REVERT Study has the potential to unlock some interesting properties that we did not previously know about eribulin.
“We hope that the findings from this trial will ultimately benefit many patients across Europe who currently are faced with such treatment challenges.”
In previous studies, eribulin monotherapy is said to have shown significant prolongation in OS in metastatic breast cancer patients that previously received an anthracycline/taxane.
Some of the most reported AEs include neutropenia, anaemia, decreased appetite, peripheral neuropathy, headache, nausea, constipation and diarrhoea.