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Key clinical point: Compared with the current standard chemoimmunotherapy, venetoclax-obinutuzumab with or without ibrutinib as first line treatment improved outcomes in fit patients with advanced chronic lymphocytic leukemia (CLL).
Major finding: The venetoclax-obinutuzumab and venetoclax-obinutuzumab-ibrutinib groups vs the chemoimmunotherapy group had significantly higher undetectable minimal residual disease rates at 15 months (86.5% and 92.2% vs 52.0%, respectively; both P < .001) and 3-year progression-free survival (hazard ratio for disease progression or death 0.42 and 0.32, respectively; both P < .001) and numerically lower fatal adverse event rate (3.9% and 3.9% vs 4.6%, respectively).
Study details: This phase 3 trial, GAIA-CLL13, included 926 fit adult patients with previously untreated, advanced CLL and no del(17p) or TP53 mutations who were randomly assigned to receive standard chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab), venetoclax-rituximab, venetoclax-obinutuzumab, or venetoclax-obinutuzumab-ibrutinib.
Disclosures: This study was supported by AbbVie, Janssen, and Roche. Some authors declared serving as consultants, advisory board members, or speakers and receiving research grants, speaker honoraria, or travel support from the study funders and others.
Source: Eichhorst B et al for the GCLLSG, the HOVON and Nordic CLL Study Groups, the SAKK, the Israeli CLL Association, and Cancer Trials Ireland. First-line venetoclax combinations in chronic lymphocytic leukemia. N Engl J Med. 2023;388(19):1739-1754 (May 11). Doi: 10.1056/NEJMoa2213093
Key clinical point: Compared with the current standard chemoimmunotherapy, venetoclax-obinutuzumab with or without ibrutinib as first line treatment improved outcomes in fit patients with advanced chronic lymphocytic leukemia (CLL).
Major finding: The venetoclax-obinutuzumab and venetoclax-obinutuzumab-ibrutinib groups vs the chemoimmunotherapy group had significantly higher undetectable minimal residual disease rates at 15 months (86.5% and 92.2% vs 52.0%, respectively; both P < .001) and 3-year progression-free survival (hazard ratio for disease progression or death 0.42 and 0.32, respectively; both P < .001) and numerically lower fatal adverse event rate (3.9% and 3.9% vs 4.6%, respectively).
Study details: This phase 3 trial, GAIA-CLL13, included 926 fit adult patients with previously untreated, advanced CLL and no del(17p) or TP53 mutations who were randomly assigned to receive standard chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab), venetoclax-rituximab, venetoclax-obinutuzumab, or venetoclax-obinutuzumab-ibrutinib.
Disclosures: This study was supported by AbbVie, Janssen, and Roche. Some authors declared serving as consultants, advisory board members, or speakers and receiving research grants, speaker honoraria, or travel support from the study funders and others.
Source: Eichhorst B et al for the GCLLSG, the HOVON and Nordic CLL Study Groups, the SAKK, the Israeli CLL Association, and Cancer Trials Ireland. First-line venetoclax combinations in chronic lymphocytic leukemia. N Engl J Med. 2023;388(19):1739-1754 (May 11). Doi: 10.1056/NEJMoa2213093
Key clinical point: Compared with the current standard chemoimmunotherapy, venetoclax-obinutuzumab with or without ibrutinib as first line treatment improved outcomes in fit patients with advanced chronic lymphocytic leukemia (CLL).
Major finding: The venetoclax-obinutuzumab and venetoclax-obinutuzumab-ibrutinib groups vs the chemoimmunotherapy group had significantly higher undetectable minimal residual disease rates at 15 months (86.5% and 92.2% vs 52.0%, respectively; both P < .001) and 3-year progression-free survival (hazard ratio for disease progression or death 0.42 and 0.32, respectively; both P < .001) and numerically lower fatal adverse event rate (3.9% and 3.9% vs 4.6%, respectively).
Study details: This phase 3 trial, GAIA-CLL13, included 926 fit adult patients with previously untreated, advanced CLL and no del(17p) or TP53 mutations who were randomly assigned to receive standard chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab), venetoclax-rituximab, venetoclax-obinutuzumab, or venetoclax-obinutuzumab-ibrutinib.
Disclosures: This study was supported by AbbVie, Janssen, and Roche. Some authors declared serving as consultants, advisory board members, or speakers and receiving research grants, speaker honoraria, or travel support from the study funders and others.
Source: Eichhorst B et al for the GCLLSG, the HOVON and Nordic CLL Study Groups, the SAKK, the Israeli CLL Association, and Cancer Trials Ireland. First-line venetoclax combinations in chronic lymphocytic leukemia. N Engl J Med. 2023;388(19):1739-1754 (May 11). Doi: 10.1056/NEJMoa2213093