Date: 2017-06-03
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: XBiotech (USA - TX)
Product: Xilonix™
Action mechanism: monoclonal antibody. Xilonix™ is the first monoclonal antibody to specifically target and neutralize interleukin-1 alpha (IL-1 alpha), one of the most potent inflammatory signaling molecules. The IL-1 pathway in general, and IL-1 alpha in particular, is a desirable target for anti-cancer therapy because of its potential role in both local and systemic effects of cancer. IL-1 alpha in the tumor microenvironment is known to promote angiogenesis as well as mediate symptoms such as metabolic dysregulation, fatigue and anxiety associated with advanced cancer.
Disease: advanced colorectal cancer
Therapeutic area: Cancer - Oncology
Country: Poland
Trial details: The primary objective of this study will be to assess how effective Xilonix is in the treatment of patients with symptomatic colorectal cancer. By blocking a substance that helps tumours grow and spread, Xilonix therapy may not only slow tumour growth, but also may improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with colorectal cancer. The effectiveness of the therapy will be measured by assessing the change in these symptoms for patients treated with Xilonix versus those treated with placebo. Reversal of muscle loss will be assessed with a type of X-ray called a DEXA scanner. Improvement in pain, appetite loss, and fatigue will be measured with a questionnaire that is completed by patients enrolled on the trial. (NCT02138422)
Latest news: • On June 3, 2017, data from XBiotech’s European Phase III Study of advanced colorectal cancer patients treated with Hutruo (MABp1) have been presented at the 2017 American Society of Clinical Oncology (ASCO) meeting in Chicago, Illinois. The abstract entitled, “MABp1 improves clinical outcomes of patients with symptomatic refractory metastatic colorectal cancer patients: Per-Protocol Population analysis of Phase III Study (PT026)” was presented during the Gastrointestinal Colorectal Cancer poster sessio. Dr. Lucjan Wyrwicz from the Maria Sklodowska-Curie Memorial Cancer Centre, Institute of Oncology, Warsaw, was leading the poster session. The poster provides analysis of how patients performed during and after treatment with the prescribed 8 week treatment regimen. Patients that received the full 8 weeks of treatment are considered to have completed the study “per protocol” (i.e. did not leave the study early). Assessment of the treatment outcome for the per protocol group is particularly important, since due to the advanced stage of these patients, some are unable to complete the recommended treatment regimen and are not able to have the full potential benefit from therapy. In the Phase III study, 82% of all patients that received at least one dose of study drug did complete the 8 week treatment regimen. For these per protocol patients, 40% of patients that received treatment with the antibody therapy achieved the primary endpoint, nearly double compared to placebo (40% vs 23%, relative risk 1.76, 95% CI 1.14 to 2.72, one-tailed p=0.003). Dr. Wyrwicz is providing an analysis showing how patients in this population that achieved the primary endpoint of the study had substantially improved survival outcomes, with a median survival of 11.7 months versus 5.7 months for those that did not (HR 0.39; p<0.0001). Other key findings include RECIST assessment of tumor progression, where radiographic evidence of stable disease was more than three-fold better (42% vs 12%; p<0.001) in this population.
