Xilonix Shows Efficacy in Advanced Colorectal Cancer

Xilonix is the first monoclonal antibody immunotherapy that targets and neutralizes interleukin-1 alpha.

MABp1 (Xilonix) was found to be well tolerated and improved outcomes in patients with advanced colorectal cancer during a phase 3 trial.

Xilonix is the first monoclonal antibody immunotherapy that both targets and neutralizes interleukin-1 alpha (IL-1α). The study’s findings were presented at the European Society for Medical Oncology’s 18th World Congress of Gastrointestinal Cancer.

“IL-1α in tumors promotes angiogenesis, helping to provide crucial blood supply for tumor growth, and it can also send the body’s metabolism out of control, causing it to burn muscle and lose weight,” said lead investigator Tamas Hickish. “At the same time, IL-1α effects on the brain can cause the fatigue, anxiety, and anorexia associated with advanced cancer.”

For the study, researchers enrolled 309 metastatic colorectal cancer patients who were unresponsive to irinotecan and oxaliplatin chemotherapy. Participants also showed a high degree of symptoms, weight loss, elevated systemic inflammation, and functional impairment.

Patients were randomized in a 2:1 ratio to receive Xilonix with best supportive care or placebo and supportive care.

The results of the study found an association between treatment with Xilonix and a significant 76% relative increase in clinical response rate. Those who had a clinical repose lived nearly 3 times as long as patients who did not respond (11.5 months versus 4.2 months).

Researchers also saw a correlation between measures of improved health status and improvement in almost all other self-reported and laboratory-based measures of health, including improved control of tumor-related white blood cell activity and a reduction in systemic inflammation. Furthermore, there were one-quarter fewer serious adverse events in the Xilonix arm compared with placebo.

In addition to evaluating Xilonix, researchers also implemented new criteria for objective response based on control of symptoms. The criteria were developed in collaboration with the European Medicines Agency’ Scientific Advice Working Group, and applied in conjunction with EORTC-QLQC30 and dual-energy X-ray absorptiometry in order to assess disease control.

“These data suggest Xilonix is very well tolerated, and has the potential to meet the real and urgent need for more effective, less toxic therapies for patients with advanced colorectal cancer,” Hickish said. “This study also provides the first evidence that health status can actually be used to measure efficacy of anti-tumor therapy in advanced, refractory colorectal cancer, and that clinical responses based on health status can be a predictor of overall survival benefit.”