Polyphor is investigating balixafortide in combination with eribulin in its pivotal Phase III study FORTRESS. The trial is treating patients with HER2 negative, locally recurrent or metastatic breast cancer, as was reported in a press release. Balixafortide is reportedly the “only CXCR4 antagonist in development for breast cancer and is the most advanced CXCR4 antagonist being developed in solid tumors”. The antagonist is being developed to improve therapy outcomes in cancer when used in combination with other agents.
“There is a significant unmet need for new treatment options for women with metastatic breast cancer who have failed initial standard-of-care chemotherapies,” said Giacomo Di Nepi, Chief Executive Officer of Polyphor. “Developing a new treatment option will provide new hope for women with this devastating disease.”
In enrolling the first patient, the study is on course. It will comprise a total of 384 patients with HER2 negative metastatic breast cancer. “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,” commented Giacomo Di Nepi. Subject to the data, Polyphor can submit a filing for accelerated approval approximately six months after the recruitment is completed.