Patients in the treatment arm were also 53% more likely to achieve stable disease compared with placebo at 8 weeks (P = .12).
Although the study was not looking for differences in serious adverse events between the 2 arms, researchers observed a 26% reduction in the risk for developing serious adverse events in the MABp1 arm compared with the placebo arm (P = .062).
In terms of safety, results to date suggest a unique safety profile for monoclonal antibody therapy that is expected to be among the most tolerated oncologic therapies.
“This study serves as a confirmation that Xilonix is a unique anti-cancer agent for gently treating patients with advanced cancer,” said John Simard, CEO of XBiotech. “The study also represents a milestone in the development of new clinical endpoints to assess efficacy of novel treatments that help heal patients with advanced disease.”1
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One additional phase 3 trial is currently evaluating MABp1, in patients with refractory, metastatic colorectal cancer. It will investigate overall survival, changes in lean body mass and quality of life, progression-free survival, and objective response rate.3
“We look forward to seeking approval to deliver this unprecedented cancer agent to patients,” Simard said.
- XBiotech reports additional positive data from phase III European trial of Xilonix™ in advanced colorectal cancer [news release]. Austin, TX: XBiotech; January 8, 2016. http://www.xbiotech.com/about/news/xbiotech-reports-additional-positive-data-from-phase-iii-european-trial-of-xilonix-in-advanced-colorectal-cancer.html. Accessed January 11, 2016.
- What are the key statistics about colorectal cancer? American Cancer Society website. http://www.cancer.org/cancer/colonandrectumcancer/detailedguide/colorectal-cancer-key-statistics. Published August 13, 2015. Accessed January 11, 2016.
- A phase 3 study to evaluate Xilonix as an anticancer therapy in patients with symptomatic colorectal cancer. Clinical Trials website. https://clinicaltrials.gov/ct2/show/NCT02138422?term=xilonix&rank=1. Updated January 4, 2016. Accessed January 11, 2016.