EQS Group-News: Polyphor AG
/ Key word(s): Conference
Allschwil, Switzerland, May 14, 2020
Polyphor announces acceptance of balixafortide abstract at the American Society of Clinical Oncology (ASCO) 2020 virtual scientific program
Polyphor AG (SIX: POLN) a research-driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing first-in-class molecules in oncology and antimicrobial resistance announced today that the abstract "Balixafortide (a CXCR4 antagonist) plus eribulin in HER2 negative metastatic breast cancer: dose-response analysis of efficacy from Phase I single arm trial" has been accepted for the ASCO 2020 Virtual Conference, which is being held from May 29-31. The data, published online on the ASCO Meeting Library, show a consistent dose response of increasing doses of balixafortide in combination with the approved dose of eribulin.
"This analysis published and supported by the steering committee of the study demonstrates an impressive overall efficacy of balixafortide at the dose of 5.5mg/kg in comparison to lower doses of balixafortide and to historical results of eribulin monotherapy in comparable populations. This benefit is observed consistently throughout all efficacy endpoints," said Peter Kaufman, Professor of Medicine, and Hematology/Oncology, at the University of Vermont Cancer Center and lead author of the abstract. Frank Weber, MD, CMDO of Polyphor adds: "Polyphor is looking forward to the results of the ongoing Phase III study FORTRESS which investigates the efficacy and safety of balixafortide at the 5.5mg/kg dose in combination with eribulin. We have randomized a total of 273 patients by today and plan to complete the enrollment of 384 patients into FORTRESS by September 2020."
The FORTRESS (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial which will investigate 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 will comprise a total of 384 patients with HER2 negative MBC, of which 320 patients receiving third or subsequent line and 64 patients receiving second line chemotherapy. Subject to the data Polyphor will have the possibility to submit a filing for accelerated approval approximately six months after the recruitment is completed on the basis of the analysis of the objective response rate (ORR), confirmed by an independent blinded review, and of the associated durability of response. The full approval would be based on the magnitude of Progression Free Survival (PFS) on blinded independent review, supported by an overall survival trend favoring balixafortide arm and a favorable risk-benefit profile. For more information about the POL6326-009 clinical trial of balixafortide, please visit www.clinicaltrials.gov (Identifier: NCT03786094)
Document title: Polyphor_14.5.2020
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