On June 28, 2021 Polyphor AG (SIX: POLN), a research driven clinical stage, Swiss biopharmaceutical company committed to discovering and developing best-in-class molecules in oncology and antimicrobial resistance reported 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 (Press release, Polyphor, JUN 28, 2021, View Source [SID1234584398]).
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At the primary analysis, balixafortide plus eribulin showed no improvement in the objective response rate (ORR) compared with eribulin alone (13.0% versus 13.7%; p=1.00) in the third line and later population (n=330 patients) 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 analyze the data, review with the experts and will decide about the future of the study in mid-July.
The board of directors is 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.
"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," says Gökhan Batur, CEO of Polyphor. "We thank all the patients, investigators and healthcare professionals as well as our employees for their active participation in this study."
About the FORTRESS study
The FORTRESS study (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial which investigates 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. The study had randomized 432 patients with HER2 negative MBC with at least 344 patients receiving third or subsequent line and 88 patients receiving second line chemotherapy.
About balixafortide
Balixafortide (POL6326) is a potent, specific, and highly selective antagonist of the chemokine receptor CXCR4, a G-protein coupled receptor (GPCR) that regulates the trafficking and homing of both cancer cells and cells of the patient’s immune system.