Plain Language Summary of the iNNOVATE Study: Ibrutinib Plus Rituximab is Well-Tolerated and Effective in People with Waldenström's Macroglobulinemia

Abstract

What is this summary about?

This article provides a short summary of 5-year results from the iNNOVATE trial. The original paper was published in the Journal of Clinical Oncology in October 2021. People with Waldenström's macroglobulinemia (WM) were randomly divided into two groups of 75 people each. One group received a combination treatment composed of two drugs, ibrutinib plus rituximab, and the other group took placebo (“sugar pill”) plus rituximab. Ibrutinib (also known by the brand name Imbruvica^®) is a drug that reduces cancer cells' ability to multiply and survive. Ibrutinib is an FDA-approved drug for the treatment of WM. Rituximab is a drug that helps the immune system find and kill cancer cells. Participants in the trial were treated and their health monitored for up to 5 years (63 months).

What were the results?

During the 5 years of monitoring, more people who took ibrutinib plus rituximab experienced an improvement in their disease and lived longer without their disease getting worse compared to those who took placebo plus rituximab. Side effects from ibrutinib and rituximab were manageable and generally decreased over time. Participants in both study groups reported improvements in quality of life, but those who took ibrutinib plus rituximab reported significantly greater improvement in their quality of life (as measured by FACT-An score) compared to those who took placebo plus rituximab.

What do the results mean?

These results show that ibrutinib plus rituximab is better than rituximab alone in people with WM and that ibrutinib plus rituximab is safe and effective in the long term. This information confirms the role of ibrutinib plus rituximab as a standard of care for WM.

Clinical Trial Registration: NCT02165397 (ClinicalTrials.gov)

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Link to original article here

Keywords::

• B-cell lymphoma
• ibrutinib
• rituximab
• Waldenström's macroglobulinemia

Acknowledgments

The authors thank the patients who participated in the study and their supportive families, as well as the investigators and clinical research staff from the study centers. Editorial support for development of this summary was provided by Cindi A. Hoover, PhD, and was funded by Pharmacyclics LLC, an AbbVie Company.

Financial & competing interests disclosure

Full author disclosure information can be found in the original article.