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

Author

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  • 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
    University College London
    Francis Crick Institute)

  • 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)

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

Suggested Citation

  • 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 Ritg, 2023. "Transcriptomic profiles and 5-year results from the randomized CLL14 study of venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab in chronic lymphocytic leukemia," Nature Communications, Nature, vol. 14(1), pages 1-12, December.
    • Handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-023-37648-w
    DOI: 10.1038/s41467-023-37648-w
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    References listed on IDEAS

    as
    1. Dan A. Landau & Eugen Tausch & Amaro N. Taylor-Weiner & Chip Stewart & Johannes G. Reiter & Jasmin Bahlo & Sandra Kluth & Ivana Bozic & Mike Lawrence & Sebastian Böttcher & Scott L. Carter & Kristian , 2015. "Mutations driving CLL and their evolution in progression and relapse," Nature, Nature, vol. 526(7574), pages 525-530, October.
    2. Carmen D. Herling & Nima Abedpour & Jonathan Weiss & Anna Schmitt & Ron Daniel Jachimowicz & Olaf Merkel & Maria Cartolano & Sebastian Oberbeck & Petra Mayer & Valeska Berg & Daniel Thomalla & Nadine , 2018. "Clonal dynamics towards the development of venetoclax resistance in chronic lymphocytic leukemia," Nature Communications, Nature, vol. 9(1), pages 1-8, December.
    Full references (including those not matched with items on IDEAS)

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