Eisai Phase 3 study of Halaven failed to meet co-primary endpoints

9th July 2012 (Last Updated July 9th, 2012 18:30)

Eisai has reported preliminary results of the Phase 3 study of Halaven versus capecitabine (Xeloda) in patients with locally advanced or metastatic breast cancer.

Esai

Eisai has reported preliminary results of the Phase 3 study of Halaven versus capecitabine (Xeloda) in patients with locally advanced or metastatic breast cancer.

The open-label, randomised study failed to meet the pre-specified criteria for either of the co-primary endpoints of overall survival (OS) and progression-free survival (PFS).

President of Eisai Oncology Product Creation Unit, Kenichi Nomoto, said that the study was a head-to-head comparison designed to show superiority against a commonly used drug approved in an earlier line of therapy than the FDA-approved indication for Halaven.

"We will look closely at the full data results to determine meaningful learnings for the medical community," Nomoto added.

"Eisai remains committed to evaluating the safety and efficacy of eribulin in patients living with locally advanced or metastatic breast cancer, an area of significant unmet medical need."

The trial included 1,102 women with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes either in the (neo) adjuvant setting or for locally advanced or metastatic disease.

The study observed a trend toward improved OS for patients who received Halaven compared with capecitabine, but the improvement was not statistically significant. No difference was reported in PFS.

The company is conducting a detailed analysis of the data, such as the secondary endpoints and subgroups pre-specified in the study protocol, and is planning to discuss the data with health authorities for regulatory filing.

Adverse events observed in the two-parallel-arm, multicentre study were consistent with the known safety profile of Halaven found in the full prescribing information.

Halaven, a natural product that was isolated from the marine sponge Halichondria okadai, is indicated for patients with breast cancer who have received at least two other types of anticancer medicines for their breast cancer once it has spread.


Image: Eisai's Phase 3 breast cancer study of Halaven did not meet the pre-specified criteria for either of the co-primary endpoints of OS and PFS. Photo courtesy of: ja.wikipedia.