Venetoclax: A Review in Previously Untreated Chronic Lymphocytic Leukaemia
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ADIS DRUG EVALUATION
Venetoclax: A Review in Previously Untreated Chronic Lymphocytic Leukaemia Hannah A. Blair1 © Springer Nature Switzerland AG 2020
Abstract Venetoclax (Venclexta®; Venclyxto®) is a first-in-class, oral, selective inhibitor of B cell lymphoma 2 (BCL2). In several countries, including the USA and those of the EU, venetoclax is indicated in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Approval was based on the results of the phase III CLL14 trial in patients with previously untreated CLL and co-existing conditions. In this study, fixed-duration (12 months) targeted treatment with venetoclax + obinutuzumab resulted in significantly longer progression-free survival (PFS; primary endpoint) relative to fixed-duration chemoimmunotherapy with chlorambucil + obinutuzumab. Venetoclax + obinutuzumab was also associated with significantly higher rates of undetectable minimal residual disease (MRD), complete response and overall response than chlorambucil + obinutuzumab. Improvements in clinical outcomes with venetoclax + obinutuzumab were maintained during long-term follow-up, when all patients had been off treatment for ≥ 2 years. No significant between-group difference was observed in overall survival (OS). Venetoclax had an acceptable tolerability profile. Notable adverse events such as grade 3 or 4 neutropenia can be managed with supportive therapy and venetoclax dose modifications. In conclusion, fixed-duration venetoclax + obinutuzumab represents an important chemotherapy-free first-line treatment option for patients with CLL, particularly those who are not fit enough to receive intensive chemoimmunotherapy. Venetoclax: clinical considerations in previously untreated CLL First-in-class, oral, selective inhibitor of the anti-apoptotic protein BCL2 Fixed-duration (12 months) venetoclax + obinutuzumab is more effective than chlorambucil + obinutuzumab in prolonging PFS and inducing undetectable MRD No significant between-group difference in OS Acceptable tolerability profile Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.13146479. The manuscript was reviewed by: M. J. S. Dyer, The Ernest and Helen Scott Haematological Research Institute, University of Leicester, Leicester, UK; S. Opat, School of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia; T. Robak, Department of Hematology, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland. * Hannah A. Blair [email protected] 1
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1 Introduction Chronic lymphocytic leukaemia (CLL), a B cell malignancy that occurs mainly in older age [1], is the most common type of adult leukaemia in the Western world [1–3]. CLL is characterized by the progressive proliferation and accumulation of B cells in the blood, bone marrow, lymph nodes and spleen [3–5]. The clinical course of the disease is heterogene
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