Pooled outcomes data back Imbruvica potential in high risk CLL/SLL patients

An analysis of data pooled from three Phase III studies evaluating Imbruvica (ibrutinib) use in patients with high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): RESONATETM, RESONATETM-2 and HELIOS.

Imbruvica, a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Pharmacyclics, an AbbVie (NYSE: ABBV) company, and Janssen Biotech, a subsidiary of healthcare giant Johnson & Johnson (NYSE: JNJ). The drug has Food and Drug Administration and European approval, and generated first-quarter 2017 sales of $551 million and $409 million for AbbVie and J&J, respectively.

In this analysis, the CLL/SLL patients with genomic abnormalities that typically put them at high risk for poor outcomes achieved higher complete response (CR) rates and overall response rates (ORR), as well as longer progression free survival (PFS) at 24 months and overall survival (OS) at 30 months, when treated with Imbruvica versus comparator-treated patients. In RESONATE, patients received Imbruvica or ofatumumab; in RESONATE-2, patients received Imbruvica or chlorambucil; and in HELIOS, patients received Imbruvica plus bendamustine and rituximab (BR) or placebo plus BR.