Polyphor, a clinical-stage biopharmaceutical company declared that it has completed enrollment in its FORTRESS Phase III trial of balixafortide in locally recurrent breast cancer. 411 patients are recruited which includes 323 in the third line and 88 patients in the second-line cohort. As Polyphor will allow patients who have already registered to enroll even after closing the recruitment, the final number is estimated to reach 430. According to the reports, the data on the crucial endpoint of FORTRESS, progression-free survival (PFS) in the total population is planned for Q4 2021. A study of the objective response rate (ORR) in appropriate patients in third and later lines of chemo is strategized for Q2 2021.
The FORTRESS study is a global, randomized active-controlled, multicenter, open-label Phase III study that will investigate the safety, tolerability, and effectiveness of intravenous balixafortide with eribulin in the treatment of HER2 negative, metastatic, or locally recurrent breast cancer.
The Chief Medical and Development Officer at Polyphor, Dr. Frank Weber, expressed his happiness about completing the recruitment process in the crucial study on time. He confirmed that presently, balixafortide is the only potent blocker of CXCR4, the main molecule engaged in tumor growth and metastasis, in the third phase development for a solid tumor and has substantial potential to improve the patients’ lives. He expressed his gratitude towards the patients, researchers, the local staff, and the employees for their active contribution to the study. He claimed that these efforts have helped them complete the enrolment on time and as planned, even after the difficulties caused by the ongoing pandemic.
Polyphor is predicted to submit a filing for faster approval in the US, based on the study of the ORR. The complete approval might be based on the extent of PFS on blinded independent review backed by a total overall survival trend supporting the balixafortide arm and a favorable risk-benefit profile.