XBiotech Inc. announced today the enrolment of the first patient into a Phase I single arm study evaluating the maximum tolerated dose of Onivyde® (Irinotecan liposome injection) and 5-fluorouracil/folinic acid in combination with MABp1 in a cohort of patients with advanced pancreatic adenocarcinoma and cachexia.
The patient has begun treatment at Cedars-Sinai Medical Center under the care of Dr. Andrew Hendifar, the Study’s Principle Investigator, Medical Oncology lead for the Gastrointestinal Disease Research Group and Co-Director of Pancreas Oncology at Cedars-Sinai. A total of 16 patients are expected to be enrolled in the study.
Dr. Hendifar commented, “We are excited to enroll our first patient in this novel combinatorial therapy for the treatment of advanced pancreatic cancer and cachexia. This is the first attempt to add an anti-inflammatory therapy to standard chemotherapy in an effort to improve the performance, quality of life, and survival in patients with this disease.”
The study will also assess overall and progression free survival as well as evaluate the relationship between treatment tolerance and patient functional status. Various secondary measures, including changes in lean body mass, weight stability and levels of systemic inflammation will also be monitored. Onivyde will be given intravenously with MABp1 and 5-fluorouracil/folinic acid every two weeks until disease progression.
The prognosis for advanced pancreatic cancer remains poor despite decades of studies . 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.
MABp1 was found to improve clusters of symptoms that included reduced pain, fatigue, improved appetite and increased lean body mass in advanced cancer patients. Patients that had these improvements were found to have less tumour progression, substantial reduced serious adverse events related to disease, and about a three-fold improvement in survival.