On May 2, 2019 XBiotech Inc. (NASDAQ: XBIT) reported enrollment of the final patient into its Phase I study1 evaluating bermekimab in patients with advanced pancreatic adenocarcinoma and cachexia (Press release, XBiotech, MAY 2, 2019, http://investors.xbiotech.com/news-releases/news-release-details/xbiotech-announces-enrollment-completion-positive-findings [SID1234535579]). The study is being conducted and led by principal investigator Andrew Hendifar, M.D., Medical Oncology lead for the Gastrointestinal Disease Research Group and Co-Director of Pancreas Oncology at Cedars-Sinai Medical Center2. A total of 18 patients are enrolled in the study.
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1NCT03207724
2 This research was partially supported through an external research grant from the US marketer of the chemotherapy product.
The purpose of the study is to assess the safety and tolerability of bermekimab in combination with chemotherapy. The study will also assess progression-free survival and overall survival of patients, as well as evaluate the relationship between treatment tolerance and patient functional status. Various health-related secondary measures, including changes in lean body mass, weight stability, and levels of systemic inflammation are also being assessed. Chemotherapy is being given intravenously with bermekimab every two weeks until disease progression. Extensive historical data on the pancreatic cancer population will be used to evaluate secondary endpoints in this study.
Dr. Hendifar commented, "We have seen excellent tolerability with bermekimab in combination with the chemotherapy regimen. Therapeutic activity and patient outcomes appear to be favorable when compared to similar pancreatic cancer patient populations refractory to therapy."
John Simard, President & CEO of XBiotech, said, "This is our first combination therapy for bermekimab and we are very happy to see this regimen may improve the tolerability and efficacy of treatment for pancreatic cancer patients. We are grateful to Cedars-Sinai, Dr. Hendifar, and especially the courageous patients for participating in the study."
The prognosis for advanced pancreatic cancer remains poor despite decades of studies [1]. The 5-year survival has remained close to 5%, unchanged despite improvements in chemotherapeutics, surgical outcomes, and diagnostic techniques [1, 2]. Other than multi-agent cytotoxic therapy, there have been no treatment advances for pancreatic cancer or its associated cachexia. Bermekimab was found to improve clusters of symptoms and led to improvements such as reduced pain and fatigue, improved appetite, and increased lean body mass in advanced cancer patients. Patients who had these improvements were found to have less tumor progression, substantially reduced serious adverse events related to disease, and approximately a three-fold improvement in survival [3].
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XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.