Polyphor announces publication of positive proof of concept data for innovative immuno-oncology candidate balixafortide in The Lancet Oncology
EQS Group-News: Polyphor AG / Key word(s): Scientific publication/Study results
Allschwil, Switzerland, April 30, 2018
The open label study recruited 56 patients with metastatic breast cancer who had previously received one to three chemotherapeutic regimens. Patients received increasing doses of balixafortide (0.5 - 5.5 mg/kg) alongside eribulin. An expanded cohort received the combination of eribulin and the recommended Phase II dose of balixafortide.
In the expanded cohort (n=24), balixafortide combined with eribulin showed a median progression free survival (PFS) of 6.2 months (n=20)[*] and a one-year survival rate of 75%. This compares to a PFS for eribulin alone of 3.7 months and survival rate of 53.9% in its registration trial for the USA ("EMBRACE")[ii]. The Clinical Benefit Rate (CBR) was 63% and Overall Response Rate (ORR) was 38% compared to a CBR of 28% and an ORR of 13% for eribulin in the EMBRACE trial.
The primary endpoints of the study were a number of safety parameters including incidents of dose limiting toxicities, type frequency and severity of AEs, determination of maximum tolerated dose, recommended Phase II dose and pharmacokinetic parameters. The safety and tolerability of balixafortide together with eribulin appeared comparable to published data on either eribulin or balixafortide monotherapy.
Dr. Javier Cortes, Head of the Breast Cancer Program at Ramon y Cajal University Hospital, Madrid, and senior Investigator at Vall d'Hebron Institute of Oncology said: "To our knowledge, this is the first clinical study exploring a CXCR4 antagonist with chemotherapy in breast cancer and the results suggest the combination of balixafortide with eribulin has potential to provide a new therapeutic option and substantial clinical benefit in heavily pre-treated metastatic breast cancer patients where there remains a significant unmet need."
"The publication of this study in one of the world's most prestigious oncology journals reflects the quality of the research and the potential importance of data which we believe shows balixafortide to be the first CXCR4 antagonist to demonstrate proof of concept in solid tumors," said Dr. Debra Barker, Chief Medical and Development Officer of Polyphor. "Following a successful end of Phase I meeting with the U.S. Food and Drug Administration (FDA), we have identified specific next steps towards a pivotal trial to potentially support registration for balixafortide in the U.S. and look forward to advancing this clinical program."
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 tumours, 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 conditional 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.
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Document: Polyphor Balixafortide Lancet 20180430
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