|AbbVie's Ibrutinib improves survival for treatment chronic lymphocytic Leukemia Patients in Phase III RESONATE-2 Trial|
|By Josh Gee|
|Thursday, 04 June 2015 18:57|
Pharmacyclics LLC, an AbbVie Inc. (NYSE:ABBV), has confirmed that ibrutinib improved progression-free survival and multiple secondary endpoints which includes overall survival and overall response rate in treating patients suffering from chronic lymphocytic leukemia.
RESONATE-2 is randomized and open-label study that makes assessment of use of ibrutinib as compared to chlorambucil in treating CLL/SLL patients with ages of 65 years or more.
The trial is the primary head-to-head trial one evaluating safety and efficacy of ibrutinib as compared to traditional chemotherapy.
IMBRUVICA is jointly developed as well as commercialized by Janssen Biotech and Pharmacyclics.
Danelle James, M.D., M.S., Head of Oncology at Pharmacyclics, opined that the firm is excited on finding of RESONATE-2 in partnership with Jannsen and it is looking forward on displaying results from potentially transformative study for CLL patients. James added that the results from IMBRUVICA study for front-line CLL patients may help in supporting future treatment paradigms.
Richard A. Gonzalez, Chairman of the Board and Chief Executive Officer at AbbVie, opined that the firm has made a lot of progress in treating CLL. He added that IMBRUVICA is demonstrating strong value and that the firm is positive that it would move into front-line treatment setting leading to an alternative option for chemotherapy.
RESONATE-2 is Pharmacyclics-sponsored trial and its specific performance goals made in special protocol assessment with U.S. Food and Drug Administration.
An SPA is an agreement with FDA stating that ongoing Phase III clinical trial design as well as other statistical analyses are agreeable to the agency for supporting an approval. The trial had 269 patients with CLL aged 65 years or more without any other treatment in U.S., EU and other regions.