Pharmaceutical Business review

Eisai doses first patient in phase 1b/2 clinical trial of eribulin in combination with PEGPH20

The collaborative phase 1b/2 clinical trial will evaluate whether the combination is beneficial to ORR in patients diagnosed with High-Hyaluronan (HA) human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

The study protocol includes metastatic HER2-negative patients with HA-high breast cancer that were previously untreated and those that received one prior line of therapy.

PEGPH20 is an investigational drug administered intravenously to target the degradation of HA, a glycosaminoglycan that can accumulate around cancer cells to inhibit other therapies.

Eribulin is a microtubule dynamics inhibitor that is believed to work primarily through a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, leading to apoptotic cell death.

In HA-high triple-negative breast preclinical animal models, the addition of PEGPH20 to eribulin demonstrated a significant increase in tumor growth inhibition and overall tumor regression when compared to eribulin alone.

Halozyme Therapeutics president and CEO Helen Torley said: "Initiation of this study is not only a major milestone in our collaboration with Eisai, it underscores our combined focus on advancing the treatment of metastatic breast cancer—one of the most common cancers in women worldwide.”