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Polyphor AG / Key word(s): Study results
Allschwil, Switzerland, May 17, 2019
The Phase Ib trial investigated balixafortide in combination with eribulin in 56 patients with advanced HER2 negative MBC. The overall survival for the expanded cohort was 50% at 18 months and 33.3% at 24 months, whereas the overall survival for the overall efficacy population was 42.4% at 18 months and 25% at 24 months. These data are consistent with the positive trend of all efficacy read-outs observed in this study and safety information is consistent with what was previously reported. Although inter-trial comparisons should be interpreted with caution, these survival rates, especially for the expanded cohort, are higher than those reported for eribulin monotherapy in similar MBC populations.These promising results suggest that balixafortide in combination with eribulin could potentially provide a new treatment option in heavily pre-treated patients with HER2 negative MBC.
Balixafortide is being developed to improve therapy outcomes in cancer, when used in combination with other agents. Balixafortide is the only CXCR4 antagonist in development for breast cancer and is the most advanced CXCR4 antagonist, being developed in solid tumors, being the first product candidate to reach proof of concept. The molecule was discovered based on Polyphor's proprietary macrocycle technology platform. Balixafortide showed strong results in a Phase Ib/proof of concept clinical trial in combination with eribulin in patients affected with advanced metastatic breast cancer. The development path identified with the input of the FDA is to conduct a single pivotal study to achieve approval in HER-2 negative metastatic breast cancer patients who previously received at least two chemotherapeutic regimens in the metastatic setting. Additionally, there is the possibility of achieving an accelerated approval based on interim results. Polyphor is also conducting preclinical work to establish the potential for balixafortide in combination with other drugs and in other oncology indications.
Document title: Polyphor_ASCO_Balixafortide_17.5.2019
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