The Medical Research Council (MRC) has awarded funding for a study of bermekimab to treat certain advanced cancers. Under its Biomedical Catalyst grant program, financial support for this study has been granted to the Institute of Genetics and Molecular Medicine (IGMM) at the University of Edinburgh in Scotland. This sponsorship is providing financing for all clinical costs to IGMM for a phase 2, multi-center study of bermekimab to treat lung, pancreatic, and ovarian cancer. The study will examine bermekimab’s reduction of debilitating symptoms such as tumor-related wasting, loss of physical function, and decreased quality of life. XBiotech is supplying drug product for the study.
Barry J. A. Laird, M.D., Senior Lecturer in Palliative Medicine at IGMM and consultant in palliative medicine at St Columba’s Hospice in Edinburgh, is heading the study.
This phase 2 open label study will be conducted at multiple cancer centers across the UK. Sixty patients with advanced lung, pancreatic, or ovarian cancer will receive bermekimab over 8 weeks. Efficacy endpoints such as change in tumor-related wasting, patient mobility, and quality of life symptoms (using the EORTC QLQ-C30 ) will be assessed. The study was developed in conjunction with the National Institute for Health Research (NIHR) Cancer & Nutrition Collaboration and the National Cancer Research Institute (NCRI) Supportive and Palliative Care Group.
Bermekimab targets the inflammatory cytokine interleukin-1 and has been used in other innovative oncology studies. The Company previously met its primary endpoint in a randomized double-blind, placebo controlled study with bermekimab for the treatment of advanced colorectal cancer. The primary endpoint in the study was a novel symptom cluster, which assessed a combination of physical symptoms—pain, fatigue, anorexia and muscle wasting—that are key measures of patient quality of life and predictors of survival. Patients treated with bermekimab were significantly more likely to achieve the primary endpoint compared to placebo (33% vs 17%, respectively); moreover, patients who achieved the primary endpoint had one-fifth as many serious adverse events, were twice as likely to have no tumor growth, showed significant and clinically relevant improvement in all life quality measures, and had almost three-fold increase in survival compared to failures.