Polyphor announces third positive Data Safety Monitoring Board (DSMB) recommendation to continue Phase III balixafortide FORTRESS study without modifications

Polyphor AG (SIX: POLN) announced today that the clinical trial independent Data Safety Monitoring Board (DSMB) has completed the third, pre-specified interim analysis, of safety outcomes based on a data cut off of 401 randomized patients 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.

"We are pleased with the DSMB recommendation that the Phase III clinical trial continues without any protocol modification." said Frank Weber, MD, CMDO of Polyphor. "We have completed the enrollment of the FORTRESS study with a total of 432 patients and are looking forward to data readouts on overall response rate (ORR) and Progression Free Survival (PFS) in Q2 and Q4 2021 respectively."

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 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).