AbbVie Inc. said the phase 3 trial of Imbruvica in combination with rituximab met its main goal in patients with treatment-naïve and previously-treated Waldenström's macroglobulinemia.
Waldenström's macroglobulinemia is a rare form of non-Hodgkin's lymphoma, a type of blood cancer.
Statistically significant results from the phase 3 iNNOVATE study showed that the combination of the two drugs worked better when compared to rituximab alone.
Rituximab, which is sold under the Rituxan brand name, is jointly marketed by Genentech Inc. and Biogen Inc.
The drug combination met its primary endpoint of progression-free survival and also achieved all secondary objectives, which included overall response rate, hematological improvement measured by hemoglobin, time-to-next treatment and overall survival.
No safety concerns were found during the study.
Imbruvica, also known as ibrutinib, is a Bruton's tyrosine kinase inhibitor and is being jointly developed by AbbVie and Johnson & Johnson.
Imbruvica is already approved in the U.S. as a monotherapy for adult patients with Waldenström's macroglobulinemia.
