Polyphor announces second positive Data Safety Monitoring Board recommendation to continue Phase III FORTRESS study without modifications
Polyphor AG (SIX: POLN) announced today that the Phase III clinical trial independent Data Safety Monitoring Board (DSMB) has completed the second, pre-specified interim analysis on July 31 of safety outcomes for 284 randomized patients (data lock June 1st) in the Phase III pivotal study with balixafortide in HER2 negative, locally recurrent or metastatic breast cancer patients. The DSMB indicated that the Phase III clinical study should continue without modifications.
"While we approach the completion of the enrollment of the FORTRESS study in the near future and many patients continue on their treatment, we are very pleased with the DSMB recommendation that the Phase III clinical trial with balixafortide continues without any protocol modification", said Frank Weber, MD, CMDO of Polyphor. "Despite the unprecedented challenges posed by the COVID-19 pandemic, and thanks to the tremendous efforts of our teams and investigators around the world, we have been able to randomize 339 patients to date."
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, with at least 320 patients receiving third or subsequent line and 64 patients receiving second line chemotherapy. Subject to the data Polyphor may be able to submit a filing for accelerated approval approximately six months after the recruitment is completed on the basis of the analysis of the overall 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).