EQS-Adhoc

Polyphor completes recruitment in Phase III trial of balixafortide in metastatic breast cancer

EQS Group-Ad-hoc: Polyphor AG / Key word(s): Study Polyphor completes recruitment in Phase III trial of balixafortide in metastatic breast cancer 29-Oct-2020 / 07:30 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 KR The issuer is solely responsible for the content of this announcement. Allschwil, Switzerland, October 29, 2020

Polyphor completes recruitment in Phase III trial of balixafortide in metastatic breast cancer

Polyphor AG (SIX: POLN) today announces that it has completed recruitment in its FORTRESS Phase III study of balixafortide in metastatic breast cancer. A total of 411 patients have been recruited, including 323 in the third line cohort and 88 patients in the second line cohort. Although recruitment is closed, Polyphor will allow all patients that have already registered for the study to be enrolled. This may increase the final number of patients enrolled in the study to approximately 430. As previously communicated, data on the key primary endpoint of FORTRESS, progression free survival (PFS) in the overall population, is planned for Q4 2021. An analysis of the objective response rate (ORR) in eligible patients in third and later lines of chemotherapy is planned for Q2 2021.

"We are pleased to have completed recruitment in this important study in a timely manner. Balixafortide is currently the only potent blocker of CXCR4, a key molecule involved in tumor growth and metastasis, in Phase 3 clinical development for a solid tumor and as such, it has significant potential to improve the lives of patients," said Dr. Frank Weber, Chief Medical and Development Officer at Polyphor. "We would like to take this opportunity to thank first and foremost the patients, but also the investigators and the local staff as well as our employees for their active participation in this study. This great effort has enabled us to complete the recruitment as planned, despite the difficulties caused by the current pandemic."