Polyphor said there has been no improvement in the results for FORTRESS, its Phase III global study for the possible treatment of patients with breast cancer.
Swiss biopharmaceutical company Polyphor has announced that its clinical trial on a potential cure for breast cancer did not meet co-primary endpoints.
In a press release, the firm said that there has been no improvement in the results for FORTRESS, its Phase III global study on the possibility of using balixafortide (POL6326) and eribulin to treat patients who have HER2 negative, locally recurrent, or metastatic breast cancer. In its early analysis, the combination of balixafortide and eribulin did not show any significant difference in the objective response rate (ORR) compared to using just eribulin, even after six months of observations. The result was 13 percent versus 13.7 percent.
Balixafortide is a potent and highly selective antagonist drug from the CXCR4 chemokine receptor, which regulates the homing and trafficking of both the patient’s immune system cells and cancer cells.
The global FORTRESS study observed 432 patients with HER2 negative MBC, with 344 participants getting their third or subsequent line chemotherapy and 88 participants who are getting second line. In addition, the Phase III trial looked into the safety, tolerability, and efficacy of using IV balixafortide with eribulin against eribulin alone.
Looking at its clinical benefit rate — its secondary endpoint — the company found response in 16.7 percent of the participants who had both balixafortide and eribulin and 19 percent in those who had just eribulin. Though the study did not meet the co-primary endpoint, it did confirm balixafortide’s tolerability and safety, similar to what is found in its Phase Ib study. It fell short on efficacy. With that said, Polyphor announced that it would continue to look deeper into its data and review the results with experts before deciding in mid-July what it would do about its research.
“Given the high unmet medical need for patients with HER2 negative breast cancer in a late stage of the disease, we are disappointed that the FORTRESS study did not meet its coprimary endpoint. We thank all the patients, investigators and healthcare professionals as well as our employees for their active participation in this study,” Gökhan Batur, chief executive of Polyphor, was quoted as saying.
Industry sources believe that the changes in the future of the company would involve either a divestment of assets and/or sales and job cuts. However, the company has not confirmed any decision or move as of this writing.
Polyphor had been working on a novel class antibiotic that targets lung infections since 2020, but pharmaceutical trends point to poor sales historically for any company that anchors on this type of drug alone. In addition, much of Polyphor’s investment had been in its cancer research, thus placing its overall future in question following the negative FORTRESS results.
Early in June, Polyphor conducted a webinar with key opinion leaders from the University of Basel, Georgetown University, and Emory University to discuss the current treatment landscape in meeting the needs of people with COVID-19, specifically in the role of the CXCR4 pathway in virus-associated mortality. At the same webinar, Polyphor’s team presented its finding on balixafortide in relation to COVID-19 infections.
