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TOPLINE:
METHODOLOGY:
- A total of 432 patients with previously untreated CLL and coexisting conditions were enrolled in the study.
- Participants were randomized 1:1 to receive either 12 cycles of venetoclax with 6 cycles of obinutuzumab or 12 cycles of chlorambucil with 6 cycles of obinutuzumab.
- The primary endpoint was PFS, with secondary endpoints including TTNT, overall survival (OS), and adverse events.
- Minimal residual disease was assessed in peripheral blood and bone marrow at the end of treatment and at several follow-up points.
- The study was conducted across multiple centers and was registered with clinical trial identifiers NCT02242942 and EudraCT 2014-001810-24.
TAKEAWAY:
- The 6-year PFS rate was significantly higher in the venetoclax-obinutuzumab group (53%) than in the chlorambucil-obinutuzumab group (21.7%) (P < .0001).
- The TTNT rate was 65.2% in the venetoclax-obinutuzumab group vs 37.1% in the chlorambucil-obinutuzumab group (P < .0001).
- The OS rate at 6 years was 78.7% in the venetoclax-obinutuzumab group and 69.2% in the chlorambucil-obinutuzumab group (P = .052).
- Patients in the venetoclax-obinutuzumab group reported better quality of life and less fatigue than those in the chlorambucil-obinutuzumab group.
IN PRACTICE:
“Patients treated with the venetoclax-obinutuzumab combination showed a statistically significant sustained prolongation of PFS, compared with patients treated with chlorambucil-obinutuzumab (76.2 vs 36.4 months). Overall, the PFS rate was 53% in the venetoclax-obinutuzumab group vs 21.7% after chlorambucil-obinutuzumab,” the study’s authors wrote.
In a related article, Silvia Deaglio, University of Turin in Italy, noted: “A second important observation of the study is that in the venetoclax-obinutuzumab arm, patients who relapsed more frequently presented with unmutated IGHV genes, deletion of 17p, or TP53 mutations.”
SOURCE:
This study was led by Othman Al-Sawaf, Sandra Robrecht, and Can Zhang, University of Cologne in Germany. It was published online on October 31 in Blood.
LIMITATIONS:
This study’s limitations included the relatively small sample size and the short duration of follow-up for some endpoints. Additionally, the study population was limited to older adult patients with coexisting conditions, which may limit the generalizability of the findings to a broader CLL population.
DISCLOSURES:
This study was supported by F. Hoffmann-La Roche and AbbVie. Al-Sawaf disclosed receiving grants from BeiGene, AbbVie, Janssen, and Roche. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- A total of 432 patients with previously untreated CLL and coexisting conditions were enrolled in the study.
- Participants were randomized 1:1 to receive either 12 cycles of venetoclax with 6 cycles of obinutuzumab or 12 cycles of chlorambucil with 6 cycles of obinutuzumab.
- The primary endpoint was PFS, with secondary endpoints including TTNT, overall survival (OS), and adverse events.
- Minimal residual disease was assessed in peripheral blood and bone marrow at the end of treatment and at several follow-up points.
- The study was conducted across multiple centers and was registered with clinical trial identifiers NCT02242942 and EudraCT 2014-001810-24.
TAKEAWAY:
- The 6-year PFS rate was significantly higher in the venetoclax-obinutuzumab group (53%) than in the chlorambucil-obinutuzumab group (21.7%) (P < .0001).
- The TTNT rate was 65.2% in the venetoclax-obinutuzumab group vs 37.1% in the chlorambucil-obinutuzumab group (P < .0001).
- The OS rate at 6 years was 78.7% in the venetoclax-obinutuzumab group and 69.2% in the chlorambucil-obinutuzumab group (P = .052).
- Patients in the venetoclax-obinutuzumab group reported better quality of life and less fatigue than those in the chlorambucil-obinutuzumab group.
IN PRACTICE:
“Patients treated with the venetoclax-obinutuzumab combination showed a statistically significant sustained prolongation of PFS, compared with patients treated with chlorambucil-obinutuzumab (76.2 vs 36.4 months). Overall, the PFS rate was 53% in the venetoclax-obinutuzumab group vs 21.7% after chlorambucil-obinutuzumab,” the study’s authors wrote.
In a related article, Silvia Deaglio, University of Turin in Italy, noted: “A second important observation of the study is that in the venetoclax-obinutuzumab arm, patients who relapsed more frequently presented with unmutated IGHV genes, deletion of 17p, or TP53 mutations.”
SOURCE:
This study was led by Othman Al-Sawaf, Sandra Robrecht, and Can Zhang, University of Cologne in Germany. It was published online on October 31 in Blood.
LIMITATIONS:
This study’s limitations included the relatively small sample size and the short duration of follow-up for some endpoints. Additionally, the study population was limited to older adult patients with coexisting conditions, which may limit the generalizability of the findings to a broader CLL population.
DISCLOSURES:
This study was supported by F. Hoffmann-La Roche and AbbVie. Al-Sawaf disclosed receiving grants from BeiGene, AbbVie, Janssen, and Roche. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- A total of 432 patients with previously untreated CLL and coexisting conditions were enrolled in the study.
- Participants were randomized 1:1 to receive either 12 cycles of venetoclax with 6 cycles of obinutuzumab or 12 cycles of chlorambucil with 6 cycles of obinutuzumab.
- The primary endpoint was PFS, with secondary endpoints including TTNT, overall survival (OS), and adverse events.
- Minimal residual disease was assessed in peripheral blood and bone marrow at the end of treatment and at several follow-up points.
- The study was conducted across multiple centers and was registered with clinical trial identifiers NCT02242942 and EudraCT 2014-001810-24.
TAKEAWAY:
- The 6-year PFS rate was significantly higher in the venetoclax-obinutuzumab group (53%) than in the chlorambucil-obinutuzumab group (21.7%) (P < .0001).
- The TTNT rate was 65.2% in the venetoclax-obinutuzumab group vs 37.1% in the chlorambucil-obinutuzumab group (P < .0001).
- The OS rate at 6 years was 78.7% in the venetoclax-obinutuzumab group and 69.2% in the chlorambucil-obinutuzumab group (P = .052).
- Patients in the venetoclax-obinutuzumab group reported better quality of life and less fatigue than those in the chlorambucil-obinutuzumab group.
IN PRACTICE:
“Patients treated with the venetoclax-obinutuzumab combination showed a statistically significant sustained prolongation of PFS, compared with patients treated with chlorambucil-obinutuzumab (76.2 vs 36.4 months). Overall, the PFS rate was 53% in the venetoclax-obinutuzumab group vs 21.7% after chlorambucil-obinutuzumab,” the study’s authors wrote.
In a related article, Silvia Deaglio, University of Turin in Italy, noted: “A second important observation of the study is that in the venetoclax-obinutuzumab arm, patients who relapsed more frequently presented with unmutated IGHV genes, deletion of 17p, or TP53 mutations.”
SOURCE:
This study was led by Othman Al-Sawaf, Sandra Robrecht, and Can Zhang, University of Cologne in Germany. It was published online on October 31 in Blood.
LIMITATIONS:
This study’s limitations included the relatively small sample size and the short duration of follow-up for some endpoints. Additionally, the study population was limited to older adult patients with coexisting conditions, which may limit the generalizability of the findings to a broader CLL population.
DISCLOSURES:
This study was supported by F. Hoffmann-La Roche and AbbVie. Al-Sawaf disclosed receiving grants from BeiGene, AbbVie, Janssen, and Roche. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.