Ibrutinib plus rituximab extends PFS in Waldenström’s macroglobulinemia

Issue: January 25, 2018

The addition of ibrutinib to rituximab extended PFS for patients with Waldenström’s macroglobulinemia, according to study results released by one of the agent’s manufacturers.

The phase 3 iNNOVATE trial evaluated ibrutinib (Imbruvica; Pharmacyclics, Janssen) — a Bruton’s tyrosine kinase inhibitor — plus rituximab (Rituxan; Genentech, Biogen) compared with rituximab alone for patients with treatment-naive or previously treated Waldenström’s macroglobulinemia.

PFS served as the primary endpoint.

An independent data monitoring committee recommended the study be unblinded based on the positive outcome from a prespecified interim analysis.

“Imbruvica is the first and only treatment approved in Waldenström’s macroglobulinemia. We continue to be committed to exploring the full potential of Imbruvica and are pleased to add the results of iNNOVATE to our growing scientific understanding of its use as a combination

therapy in Waldenström’s macroglobulinemia and other blood cancers,” Thorsten Graef, MD, PhD, head of clinical development at Pharmacyclics — an AbbVie company — said in the release.

Pharmacyclics and Janssen officials intend to provide the interim analysis data to regulatory authorities. Data will be presented in a future publication or submitted for presentation at a medical congress.

In 2015, the FDA approved ibrutinib for treatment of adults with Waldenström’s macroglobulinemia.

“This is a first-of-its-kind prospective randomized trial in Waldenström's macroglobulinemia,” Meletios A. Dimopoulos, MD, professor and chairman of the department of clinical therapeutics at National and Kapodistrian University of Athens School of Medicine, said in the release. “The full report of this study will be of important clinical significance regarding the benefits of the combination of ibrutinib with rituximab in patients with Waldenström’s macroglobulinemia.”