Pooled data from three Phase III studies of in patients with high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma: RESONATE RESONATE-2 and HELIOS achieve higher survival rates with Imbruvica (ibrutinib)- AbbVie

AbbVie announced results from 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): RESONATE RESONATE-2 and HELIOS. In this analysis, 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. The high-risk genomic abnormalities reviewed were deletion 11q (del 11q), trisomy 12, complex karyotype (CK) and unmutated immunoglobulin heavy-chain variable-region (IGHV).

In Imbruvica-treated patients, the presence of del 11q was associated with trends of longer PFS and OS than patients without del 11q when treated with Imbruvica (abstract #19). These data were presented in an oral presentation at the 17th International Workshop on Chronic Lymphocytic Leukemia (iwCLL) biennial meeting in New York, NY.

Comment: Results from data presented at the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) further suggest that risk factors typically associated with poor clinical outcomes may be less relevant with ibrutinib treatment - In ibrutinib-treated patients, the presence of deletion 11q (a difficult-to-treat genomic abnormality) was associated with trends of longer progression free survival at 24 months and overall survival at 30 months.