NORTH CHICAGO, Ill. - AbbVie (NYSE: ABBV), announced extended long-term data from the Phase 3 RESONATE-2 study (PCYC-1115/1116) evaluating single-agent IMBRUVICA (ibrutinib) versus chlorambucil with up to seven years of follow-up in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).1 These data will be presented on June 4th during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #7523). Additionally, new data will be presented during the European Hematology Association (EHA) Virtual Congress from June 9-17, including findings from the informCLL real-world prospective observational registry assessing how real-world treatment patterns align with National Comprehensive Cancer Network (NCCN)-recommended regimens for CLL/SLL.

'These data add to the overall body of evidence that patients treated with ibrutinib can achieve extended progression-free survival and overall survival when used as a first-line therapy,' said Paul M. Barr, M.D., lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. 'The results add to the extensive clinical evidence supporting the use of single-agent ibrutinib for long-term disease control.'

The RESONATE-2 study evaluated 269 patients 65 years or older with previously untreated CLL/SLL, without 17p deletion, who received continuous single-agent IMBRUVICA until progression or chlorambucil up to 12 cycles.1 With up to seven years of follow-up, progression-free survival (PFS) benefit with single-agent IMBRUVICA was sustained (Hazard Ratio [HR] 0.160 [95 percent Confidence Interval (CI): 0.111-0.230]).1 At 6.5 years of follow-up, median PFS in the IMBRUVICA treatment arm was not reached: the PFS rate for patients treated with single-agent IMBRUVICA was 61 percent compared with only nine percent in patients treated with chlorambucil.1 Additionally, at 6.5 years, the IMBRUVICA treatment arm showed an overall survival (OS) rate of 78 percent; OS was not captured for the chlorambucil treatment arm for patients with disease progression after a median of five years of follow-up.1 In this latest follow-up, the overall response rate (ORR) was 92 percent.1

With up to seven years of follow-up, the complete response (CR)/complete response increase (CRi) rate increased over time to 34 percent; median duration of response (range,

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