The proposed study is intended to support the global registration of balixafortide. Polyphor expects to enroll the first patient in the second quarter of 2019.
The FDA reviewed the design, inclusion and exclusion criteria of the international, multicenter, randomized, open-label Phase III trial which will comprise a total of 384 patients with HER2 negative MBC, of which 320 patients receiving third line and 64 patients receiving second line chemotherapy. The FDA agreed with the proposed indication for the treatment of MBC in patients who have previously received at least two chemotherapeutic regimens and confirmed the possibility to submit a filing for accelerated approval at the end of the recruitment 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 will 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.
“This FDA meeting was an important milestone to advance the development of balixafortide and potentially bringing it to the patients suffering from metastatic breast cancer, who have only limited treatment alternatives. We are excited by the opportunity to start the trial in the first quarter of 2019 and have the first patient enrolled by Q2/19,” said Giacomo Di Nepi, Chief Executive Officer of Polyphor.
Balixafortide is a potent and highly selective antagonist of CXCR4, a G-protein coupled receptor (GPCR) that regulates the trafficking and homing of both cancer cells and cells of the patient’s immune system. CXCR4 plays a critical role in tumor growth, survival, angiogenesis and metastasis[i]. High CXCR4 levels have been detected in almost all human tumor types, including breast cancer. High CXCR4 expression is known to correlate with aggressive metastatic behavior of cancer cells and a poor prognosis[ii].