Insight

A Phase Ib/II study (Study 219) presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2016 is investigating the novel combination of eribulin mesylate and PEGylated recombinant human hyaluronidase (PEGPH20) in patients with HER2-negative, metastatic breast cancer who have failed first or second-line prior chemotherapy. In an interview filmed at the symposium, the lead investigator, Ricardo Alvarez of the Cancer Centers of America, Atlanta, USA, described this study. Study 219 is a randomized, open-label, multicentre, Phase Ib/II clinical trial that involves initial administration of PEGPH20 to target the tumour microenvironment and degrade glycosaminoglycans.¹ Subsequent treatment with the microtubule inhibitor eribulin mesylate directly targets the cancer cells. Patients will be given PEGPH20, followed by eribulin mesylate after 24 h.¹ The study aims to enrol approximately 114 patients.¹

The primary endpoint of the Phase Ib portion of the study is to determine the recommended dosage of the eribulin and PEGPH20 combination.¹ Safety and efficacy data will also be reported.¹ The primary endpoint of the Phase II study is overall response rate.¹ Secondary endpoints will include progression-free and overall survival. The study includes only patients with high hyaluronan tumours in order to target a treatment-sensitive population.¹

Eribulin is indicated in the European Union for the treatment of adults 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.

This article and interview have been initiated and funded by Eisai.