Polyphor’s future in question after co-primary endpoint in breast cancer study missed

pharmafile | June 28, 2021 | News story | Sales and Marketing Primary Endpoint, breast cancer 

Swiss biopharmaceutical company, Polyphor, has announced that its global Phase III study, FORTRESS, evaluating balixafortide (POL6326) in combination with eribulin for the treatment of patients with HER2 negative, locally recurrent or metastatic breast cancer, did not meet its co-primary endpoint.

In a release Polyphor stated that the board of directors is currently undergoing a strategic assessment and will consider a full range of options regarding the future of the company and will provide an update not later than end of July.

The FORTRESS study (POL6326-009) is an international, multicentre, randomised active-controlled, open-label Phase III trial which is investigating the efficacy, safety, and tolerability of intravenous balixafortide given with eribulin, versus eribulin alone in the treatment of HER2 negative, locally recurrent or metastatic breast cancer.

At the primary analysis, balixafortide plus eribulin showed no improvement in the objective response rate compared with eribulin alone (13.0% versus 13.7%) in the third line and later population followed for a minimum of 6 months.

The clinical benefit rate, a key secondary endpoint indicating a stable disease or any confirmed response for a duration of at least 6 months as assessed by the IRC (independent radiological committee) was observed in 16.7% of patients in the balixafortide plus eribulin arm and 19.6% in the eribulin alone arm. The study confirmed the positive safety and tolerability profile of balixafortide in line with the previously reported Phase Ib study. Polyphor will continue to analyse the data, review with the experts and will decide about the future of the study in mid-July.

Gökhan Batur, CEO of Polyphor, 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.”

Kat Jenkins

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