Long-term results from a clinical study of xevinapant plus chemoradiotherapy in people with high-risk locally advanced squamous cell carcinoma of the head and neck: a plain language summary
Abstract
What is this summary about?
Squamous cell carcinoma of the head and neck (SCCHN) is the most common type of head and neck cancer. About half of the people with locally advanced (LA) SCCHN will have surgery to remove their cancer. For people who do not have surgery, chemoradiotherapy is the standard treatment, with the aim of fully removing the cancer. However, in many people, this treatment does not completely kill the cancer. This summary presents the main results of a phase 2 study of a medicine called xevinapant, which is under investigation as a potential future medicine for people with this type of cancer.
What did the researchers want to find out?
In this study, researchers wanted to find out whether xevinapant plus chemoradiotherapy could stop the cancer from growing back or getting worse in the years after treatment completion in people with LA SCCHN. They also looked at whether people with this type of cancer had side effects from taking this medicine. Short-term results were collected 18 months after treatment with chemoradiotherapy ended. These results showed that people who received xevinapant plus chemoradiotherapy were less likely to have their cancer grow back, or get worse in the part of the body where it was first found, than people who received liquid placebo—which looked and tasted the same as the active medicine (in this case, xevinapant), but did not contain any medicine—plus chemoradiotherapy. Researchers then continued to collect information for a longer amount of time (at least 3 years). They wanted to see if treatment with xevinapant plus chemoradiotherapy was stopping the cancer from growing back or getting worse and helping people live longer. After this, people were monitored for a further 2 years to see if they were alive 5 years after treatment.
What were the main findings of the study?
The results showed that people with this type of cancer who were treated with xevinapant plus chemoradiotherapy were less likely to die, lived longer on average, and were less likely to have their cancer get worse. A phase 3 study, named TrilynX, in a larger group of people, is currently taking place to confirm the results of this study.
Clinical Trial Registration:NCT02022098 (Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial) (ClinicalTrials.gov)
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Acknowledgments
The authors of this article thank the people who participated in this study and their families, as well as the investigators, co-investigators, and staff at each of the clinical sites.
Financial & competing interests disclosure
Full author disclosure information can be found in the original article. Writing support for this summary was provided by Jamie Ratcliffe of Clinical Thinking and funded by Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945).
This study was sponsored by Debiopharm International, Lausanne, Switzerland. In March 2021, Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945) gained exclusive rights to develop and commercialize xevinapant worldwide (https://www.merckgroup.com/en/news/xevinapant-01-03-2021.html).
Disclaimer
Xevinapant is not yet approved to treat any condition. This summary reports the results of a single study. The results of this study may differ from those of other studies. Health professionals should make treatment decisions based on all available evidence, not on the results of a single study.
Open access
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/
