iNNOVATE study meets primary endpoint

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AbbVie has announced that the Phase 3 iNNOVATE (PCYC-1127) trial evaluating IMBRUVICA® (ibrutinib) in combination with rituximab in patients with treatment-naïve and previously-treated Waldenström’s macroglobulinemia (WM) successfully met its primary endpoint and demonstrated improvement of progression-free survival (PFS) compared to rituximab alone.

The Independent Data Monitoring Committee recommended that the study be unblinded based on the positive outcome from the pre-specified interim analysis data.

IMBRUVICA, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech.

Pharmacyclics and Janssen are planning to share the interim analysis data from the study with regulatory authorities and plan to present the data in a future publication or medical congress. 

In January 2015, the U.S. FDA granted approval for IMBRUVICA for adult patients with WM. The approval was supported by the FDA’s Breakthrough Therapy Designation. 

WM is a rare form of non-Hodgkin’s lymphoma, and roughly 1000 to 1500 people are diagnosed each year in the U.S.

Dr Thorsten Graef, Head of Clinical Development at Pharmacyclics. said: “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 WM and other blood cancers.”

Dr Meletios A. Dimopoulos, Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, said: “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 WM.”