Transcriptomic profiles and 5-year results from the randomized CLL14 study of venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab in chronic lymphocytic leukemia

Othman Al-Sawaf (), Can Zhang, Hyun Yong Jin, Sandra Robrecht, Yoonha Choi, Sandhya Balasubramanian, Alex Kotak, Yi Meng Chang, Anna Maria Fink, Eugen Tausch, Christof Schneider, Matthias Ritgen, Karl-Anton Kreuzer, Brenda Chyla, Joseph N. Paulson, Christian P. Pallasch, Lukas P. Frenzel, Martin Peifer, Barbara Eichhorst, Stephan Stilgenbauer, Yanwen Jiang, Michael Hallek () and Kirsten Fischer ()
Additional contact information
Othman Al-Sawaf: University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf
Can Zhang: University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf
Hyun Yong Jin: Genentech Inc.
Sandra Robrecht: University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf
Yoonha Choi: Genentech Inc.
Sandhya Balasubramanian: Genentech Inc.
Alex Kotak: Roche Products Ltd
Yi Meng Chang: Hoffmann-la Roche
Anna Maria Fink: University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf
Eugen Tausch: Department III of Internal Medicine, Ulm University
Christof Schneider: Department III of Internal Medicine, Ulm University
Matthias Ritgen: Department II of Internal Medicine, University of Schleswig Holstein
Karl-Anton Kreuzer: University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf
Brenda Chyla: AbbVie Inc.
Joseph N. Paulson: Genentech Inc.
Christian P. Pallasch: University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf
Lukas P. Frenzel: University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf
Martin Peifer: University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Translational Genomics
Barbara Eichhorst: University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf
Stephan Stilgenbauer: Department III of Internal Medicine, Ulm University
Yanwen Jiang: Genentech Inc.
Michael Hallek: University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf
Kirsten Fischer: University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf

Nature Communications, 2023, vol. 14, issue 1, 1-12

Abstract: Abstract Data on long-term outcomes and biological drivers associated with depth of remission after BCL2 inhibition by venetoclax in the treatment of chronic lymphocytic leukemia (CLL) are limited. In this open-label parallel-group phase-3 study, 432 patients with previously untreated CLL were randomized (1:1) to receive either 1-year venetoclax-obinutuzumab (Ven-Obi, 216 patients) or chlorambucil-Obi (Clb-Obi, 216 patients) therapy (NCT02242942). The primary endpoint was investigator-assessed progression-free survival (PFS); secondary endpoints included minimal residual disease (MRD) and overall survival. RNA sequencing of CD19-enriched blood was conducted for exploratory post-hoc analyses. After a median follow-up of 65.4 months, PFS is significantly superior for Ven-Obi compared to Clb-Obi (Hazard ratio [HR] 0.35 [95% CI 0.26–0.46], p

Date: 2023
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DOI: 10.1038/s41467-023-37648-w

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