AbbVie's combo therapy meets goal in rare blood disease trial

The Phase III 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 (NYSE: ABBV) subsidiary, and Janssen Biotech, a unit of Johnson & Johnson (NYSE: JNJ).

Obviously, this is a big move forward for patients with Waldenstrom's, as combination with rituximab will likely become a new standard option if and when it is approved for treatment here, commented Dr Zach Hartman on the Seeking Alpha blog. These findings continue an ongoing trend of expanding the reach of ibrutinib, further cementing the return on investment for AbbVie's $21 billion acquisition of Pharmacyclics back in 2015, he noted.