Ibrutinib Improves Survival in CLL and SLL Patients: Results From the RESONATE Study

MILAN, June 13, 2014 /PRNewswire/ --

On Behalf of the RESONATE Investigators, Dr Hillmen will present the results from the Phase III trial in CLL and SLL patients. 

Patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL) who experience short response duration or adverse cytogenetics have poor outcomes. We evaluated the efficacy of ibrutinib, the first-in covalent inhibitor of Bruton's tyrosine kinase, in these difficult-to-treat patients. This multicenter, international, phase 3 study (RESONATE™) assessed daily ibrutinib monotherapy versus the anti-CD20 antibody ofatumumab. Relapsed or refractory CLL/SLL patients (N=391) were randomized to receive ibrutinib or ofatumumab. At a median follow-up of 9.4 months, ibrutinib significantly improved progression free survival (PFS); median PFS was not reached with ibrutinib and was 8.1 months with ofatumumab (hazard ratio [HR], 0.22; P<0.001). Ibrutinib also significantly improved overall survival (HR, 0.43; P=0.005). This effect was observed despite cross over from ofatumumab to ibrutinib at progression as recommended by the data monitoring committee. Similar effects were observed regardless of del17p or purine analog-refractory disease. The Response rate by IRC was 63% for ibrutinib including 20% responses with lymphocytosis vs. 4% with ofatumumab. Toxicities were manageable and did not frequently result in dose reduction or treatment discontinuation with 86.4% continuing ibrutinib at time of analysis.  In summary, ibrutinib significantly improved PFS, overall survival, and response rate compared to ofatumumab in previously treated CLL/SLL. This study validates ibrutinib as an effective new single agent therapy for CLL/SLL patients.

Presenter: Dr Peter Hillmen

Affiliation: The Leeds Teaching Hospitals, St. James's Institute of Oncology, Leeds, United Kingdom

Topic: Randomized Comparison of Ibrutinib Versus Ofatumumab in Previously Treated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma:  Results From the Phase III PCYC-1112 RESONATETM Trial.

Abstract S693 will be presented by Dr Peter Hillmen on Saturday, June 14, 2014, 14:15 - 16:00 in Room Gold (SW-Level 2).

About the EHA Annual Congress 

Hematology is a specialty that covers everything to do with blood: its origin in the bone marrow, diseases of blood and their treatments. The latest data on research and developments will be presented. The topics range from stem cell physiology and development, to leukemia, lymphoma, myeloma - diagnosis and treatment; red blood cells -, white blood cells- and platelet disorders; thrombosis and bleeding disorders.