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EQS Group-Ad-hoc: Polyphor AG / Keyword(s): Study results 03.08.2021 / 19:00 CET / Central Central European Olschwill, Switzerland, August 3, 2021 |
Polyphor provides final update to FORTRESS Phase III study with Balixafortide in patients with HER2-negative advanced breast cancer.
The study’s primary endpoint, Progression Free Survival (PFS) was not met.
Pre-specified interim analysis of overall survival (OS) did not reveal any significant differences between study groups
Polyphor AG (SIX: POLN) today announced that a global phase III study, balixafortide (POL6326) in combination with eribulin for the treatment of patients with HER2-negative, locally recurrent, or metastatic breast cancer, also verified the primary endpoint. Achieve. As described previously, the analysis was performed following the company’s decision to begin terminating the FORTRESS study.
The FORTRESS study examines the efficacy and safety of the combination of balixafortide and eribulin compared to eribulin monotherapy in patients with HER2-negative metastatic breast cancer whose disease has progressed after one to four lines of chemotherapy. Progression-free survival (PFS) is the main primary end point of the study. The FORTRESS study included 432 patients, 348 of whom had received at least two previous lines of chemotherapy, a pre-selected subset of the study.
The study did not achieve the primary end point of PFS in the overall population (n = 432 patients): HR = 1.10 (0.85, 1.41); p = 0.445; Median PFS: 3.5 months (B + E) vs 4.0 months (E) and also not in patients with two previous lines of chemotherapy as assessed by the independent examination panel (n = 348 patients): HR = 1.07 (0, 81, 1.41 ); p = 0.6158; Median PFS: 3.5 months (B+E) versus 4.0 months (E). The investigators’ assessment of PFS was consistent with that of the independent review panel (HR = 0.99 for the total population and HR = 1.05 for the >second-line group).