Journal article
Comprehensive safety analysis of Venetoclax monotherapy for patients with relapsed/refractory chronic lymphocytic leukemia
MS Davids, M Hallek, W Wierda, AW Roberts, S Stilgenbauer, JA Jones, JF Gerecitano, SY Kim, J Potluri, T Busman, A Best, ME Verdugo, E Cerri, M Desai, P Hillmen, JF Seymour
Clinical Cancer Research | AMER ASSOC CANCER RESEARCH | Published : 2018
Abstract
Purpose: The oral BCL-2 inhibitor venetoclax is an effective therapy for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), including disease with high-risk genomic features such as chromosome 17p deletion [del (17p)] or progressive disease following B-cell receptor pathway inhibitors. Patients and Methods: We conducted a comprehensive analysis of the safety of 400 mg daily venetoclax monotherapy in 350 patients with CLL using an integrated dataset from three phase I/II studies. Results: Median age was 66 years and 60% had del(17p). Patients had received a median of three prior therapies (range: 0–15); 42% previously received ibrutinib or idelalisib. Median duration ..
View full abstractGrants
Funding Acknowledgements
We would like to thank the patients and their families, study investigators, study coordinators, and support staff. Medical writing support was provided by Sharanya Ford, PhD, data-programming support was provided by Joseph Beason, and additional scientific support was provided by Cynthia Bartkus and Adrienne Rothstein; all are employees of AbbVie. Venetoclax is being developed in collaboration between AbbVie and Genentech. AbbVie and Genentech provided financial support for the studies and participated in the design, study conduct, analysis and interpretation of data, as well as the writing, review, and approval of the manuscript. Funding for the studies included in this analysis was provided by AbbVie Inc. and Genentech Inc.