Phase III Trial Finds that Anti-interleukin-1 alpha antibody MABp1 Improves Outcomes Significantly over Placebo

A novel anti-interleukin 1-alpha antibody has shown a significant impact on symptoms, and a high level of safety and tolerability in patients with advanced colorectal cancer, according to phase III data presented at the European Society for Medical Oncology’s 18th World Congress of Gastrointestinal Cancer in Barcelona, Spain. [1]

Xilonix™ (XBiotech) is the first monoclonal antibody immunotherapy to specifically target and neutralize interleukin-1 alpha (IL-1α), one of the most potent inflammatory substances manufactured by the body or tumour cells. “IL-1α in tumours 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, MD. At the same time, IL-1α effects on the brain can cause the fatigue, anxiety and anorexia associated with advanced cancer.

No response to Standard Therapy
The study enrolled 309 patients with metastatic colorectal cancer whose disease had not responded to standard chemotherapy with oxaliplatin and irinotecan and who showed a high degree of symptoms, functional impairment, weight loss or elevated systemic inflammation.

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

Patients were randomized them in a 2:1 ratio to MABp1 with best supportive care, or placebo and the same.

Treatment with MABp1 was associated with a significant 76% relative increase in clinical response rate. Patients who showed a clinical response lived almost three times as long as those who did not respond (11.5 months vs. 4.2 months).

Improved Health Status
Researchers also found that measures of improved health status correlated with improvement in almost all other self-reported and laboratory-based measures of health, including with improved control of tumor-related white blood cell activity and reduced systemic inflammation.

There were also one-quarter fewer serious adverse events in the treatment arm of the study compared to placebo.

“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,” Dr Hickish said.

“This study also provides the first evidence that health status can actually be used to measure efficacy of anti-tumour therapy in advanced, refractory colorectal cancer, and that clinical responses based on health status can be a predictor of overall survival benefit.”

References
[1] Tamas H, Thierry A, Lucjan W, Mark S, Tomasz S, Radim N, Judit K et al.  A pivotal phase 3 trial of MABp1 in advanced colorectal cancer (Abstract O-027) Presented during Session XIX: Colorectal Cancer, on Saturday, 2 July 2016, 11:15 AM (CEST).


Last editorial review: April 18, 2016. Copyright © 2016 Sunvalley Communication, LLC. All rights reserved. Republication or redistribution of Sunvalley Communication content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley Communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Onco'Zine and Oncozine are registered trademarks and trademarks of Sunvalley Communication around the world.

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