Swiss biotech Polyphor has reported that its investigational asset, balixafortide, has failed to meet co-primary endpoint in a late-stage breast cancer study.

The global Phase III study, FORTRESS, assessed the effectiveness of balixafortide (POL6326) in combination with eribulin for treating patients with HER2 negative, locally recurrent, or metastatic breast cancer.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

A primary analysis of the results shows that the combination drug did not improve objective response rate (ORR) when compared with eribulin alone arm (13.0% versus 13.7%; p=1.00) in the third line and later population followed for a minimum of six months.

The eribulin alone arm also outperformed the balixafortide plus eribulin arm in clinical benefit rate, a key secondary endpoint of the study.

However, the safety and tolerability profile of balixafortide in the study was in line with the previously reported Phase Ib study.

The company will continue to assess the study data, review it with experts, and confirm its future next month.

Polyphor CEO Gökhan Batur said: “Given the high unmet medical need for patients with HER2 negative breast cancer in a late stage of the disease, we are disappointed that the FORTRESS study did not meet its coprimary endpoint.

“We thank all the patients, investigators and healthcare professionals, as well as our employees for their active participation in this study.”

The failure of the FORTRESS study also forced Polyphor board of directors to initiate a strategic assessment regarding the future of the company. The assessment will explore multiple options and will provide an update before the end of next month.