03 Jun CLL: Ibrutinib (IMBRUVICA®) Demonstrated Durable Responses for High Risk Patients
MedicalResearch.com Interview with:
Paul M. Barr, M.D.
Associate Professor of Medicine and Director of the Clinical Trials Office
Director of the Clinical Trials Office
Wilmot Cancer Institute
MedicalResearch.com: What is the background for this study?
Response: When the study was designed, chronic lymphocytic leukemia (CLL) treatment options were largely limited to chemotherapy and monoclonal antibodies.
Ibrutinib had shown promise in early studies. The intent was to compare ibrutinib to a standard of care treatment option at that time, of atumumab, in patients with relapsed or refractory disease. The goal of the current analysis is to evaluate the durability of ibrutinib and report the long-term safety results.
MedicalResearch.com: What are the main findings?
Response: Extended follow up demonstrates that ibrutinib provides durable responses for many patients. In this predominantly high-risk group, 41% received >4 years of ibrutinib therapy. The median PFS was 44 months with the highest risk patients performing equally as well. Further, no new safety concerns were identified.
MedicalResearch.com: What should readers take away from your report?
Response: Based on this study and others, Ibrutinib remains an excellent treatment option for this population and for CLL patients receiving first line therapy.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Ongoing studies are investigating ibrutinib based combinations in order to provide deep remissions with treatment plans of limited duration.
MedicalResearch.com: Is there anything else you would like to add?
Response: While novel combinations are of considerable interest, this study demonstrates that many patients are served well with single agent ibrutinib administered until disease progression.
Citation: ASCO abstract Monday June 3, 2019
Final analysis from RESONATE: Six-year follow-up in patients (pts) with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) on ibrutinib.
Author(s): Paul M. Barr, Talha Munir, Jennifer R. Brown, Susan Mary O’Brien, Jacqueline Claudia Barrientos, Nishitha M. Reddy, Steven Coutre, Constantine Si Lun Tam, Stephen P. Mulligan, Ulrich Jäger, Thomas J. Kipps, Carol Moreno, Marco Montillo, Jan Andreas Burger, John C. Byrd, Peter Hillmen, Sandra Dai, Anita Szoke, James P. Dean, Jennifer Ann Woyach; University of Rochester Medical Center, Rochester, NY; St James’s University Hospital, Leeds, United Kingdom; Dana-Farber Cancer Institute, Boston, MA; University of California, Irvine, Irvine, CA; Hofstra Northwell School of Medicine, Hempstead, NY; Vanderbilt University Ingram Cancer Center, Nashville, TN; Stanford University School of Medicine, Stanford, CA; Peter MacCallum Cancer Centre, St. Vincent’s Hospital, University of Melbourne, Melbourne, Australia; University of Sydney, Royal North Shore Hospital, Sydney, Australia; Clinical Division of Hematology and Hemostaseology, Department of Medicine I, Vienna General Hospital–Medical University of Vienna, Vienna, Austria; University of California San Diego Moores Cancer Center, La Jolla, CA; Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Department of Haematology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy; The University of Texas MD Anderson Cancer Center, Department of Leukemia, Houston, TX; The Ohio State University, Division of Hematology, Columbus, OH; St. James’s University Hospital, Leeds, United Kingdom; Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA; The Ohio State University Comprehensive Cancer Center, Columbus, OH
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