Janssen reports interim results from HELIOS trial of Imbruvica + bendamustine + rituximab in CLL/SLL.

Data from the Phase III CLL3001 (HELIOS) trial demonstrated that the combination of ibrutinib (Imbruvica) plus bendamustine and rituximab (BR) reduced the risk of progression or death by 80% and also significantly improved overall response rate (ORR) versus placebo plus BR in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Janssen Research & Development, LLC (Janssen) announced these data, which were presented at ASCO by the lead author of the study, Dr. Asher Chanan-Khan, based at the Mayo Clinic in Jacksonville, Florida.

At a median follow-up of 17 months, IRC-assessed PFS (progression free survival) was significantly longer with ibrutinib+BR, compared to placebo+BR (median not reached vs. 13.3 months; HR: 0.203, 95% CI: 0.150-0.276, P<0.0001).this difference in pfs rates between study arms was consistent across all subgroups including high-risk subgroups. irc-assessed pfs rates at 18 months were 79 for patients in the ibrutinibbr arm as compared with 24 for patients in the placebobr arm. the irc-assessed orr and complete response complete response with incomplete marrow recovery cr cri rates were 82.7 and 10.4 respectively for patients taking ibrutinibbr versus 67.8 and 2.8 for people in the placebobr arm. the median os overall survival has not yet been reached at a median follow-up of 17 months. overall ibrutinib reduced the risk of death by 37 p="0.06).">

Imbruvica is jointly developed and commercialized by Janssen Biotech, Inc.and Pharmacyclics LLC.