Polyphor today announced the enrollment of the first patient in its FORTRESS clinical trial, the pivotal Phase III study evaluating balixafortide (POL6326) in combination with eribulin for the treatment of patients with HER2 negative, locally recurrent or metastatic breast cancer (MBC). Balixafortide is the only CXCR4 antagonist in development for breast cancer and is the most advanced CXCR4 antagonist being developed in solid tumors.
"The enrollment of the first patient in our Phase III clinical study is a significant step forward for the development of balixafortide. There is a significant unmet need for new treatment options for women with metastatic breast cancer who have failed initial standard-of-care chemotherapies. Developing a new treatment option will provide new hope for women with this devastating disease," said Giacomo Di Nepi, Chief Executive Officer of Polyphor. "We are hopeful that the response rates seen in our proof-of-concept study can be replicated in the FORTRESS trial and that balixafortide can make a positive impact on patient outcomes."
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)