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).


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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.

Reference

  1. 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.
  2. 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.
  3. 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.