AbbVie announced 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 (IDMC) 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 commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech.
"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 WM and other blood cancers," said Thorsten Graef, M.D., Ph.D., Head of Clinical Development at Pharmacyclics.
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 1,000 to 1,500 people are diagnosed each year in the U.S.