Venclexta Plus Gazyva Induces Minimal Residual Disease, Improves Survival in CLL

First-line treatment with Venclexta (venetoclax) and Gazyva (obinutuzumab) — with or without Imbruvica (ibrutinib) — was superior to chemoimmunotherapy for patients with chronic lymphocytic leukemia (CLL), according to findings from a recent phase 3 trial.

Results from this trial, which were published in The New England Journal of Medicine, demonstrated that treatment with Venclexta and Gazyva, regardless of Imbruvica use, may induce undetectable minimal residual disease and prolong progression-free survival.

Researchers assessed data from 926 patients with CLL who did not have mutations on the TP53 gene. Of note, genetic mutations on this specific gene may cause cancer cells to grow and spread throughout the body, according to the National Cancer Institute.

Patients in this trial were also considered fit, meaning they had a low burden of coexisting conditions.

Patients enrolled in the trial were randomly assigned chemoimmunotherapy (229 patients); Venclexta plus Rituxan (rituximab; 237 patients); Venclexta plus Gazyva (229 patients); or Venclexta plus Gazyva and Imbruvica (231 patients).

Researchers focused on several outcomes throughout the trial including undetectable minimal residual disease (a small number of cancer cells in the body during or after treatment, which can indicate how well a treatment is working) at 15 months and progression-free survival (the time during and after treatment when a patient with cancer is alive without disease worsening).

At 15 months, the Venclexta-Gazyva and then Venclexta-Gazyva-Imbruvica groups had significantly higher percentages of patients with undetectable minimal residual disease (86.5% and 92.2%, respectively).

“These percentages are among the highest reported in first-line therapy for CLL,” the researchers wrote in the study.

Also at this time point, 52% of patients assigned chemoimmunotherapy achieved undetectable minimal residual disease compared with 57% of those assigned Venclexta plus Rituxan.

“Data from this trial confirm the superiority of (Venclexta)-(Gazyva) over even more potent chemoimmunotherapy regimens than chlorambucil (Leukeran)-(Gazyva) and are leading to the approval of (Venclexta)-(Gazyva) for CLL,” the study authors added.

Venclexta plus Gazyva resulted in superior progression-free survival in patients with CLL.

Three-year progression-free survival in patients treated with Venclexta plus Gazyva was 90.5% compared with 75.5% in those treated with chemoimmunotherapy. Patients treated with Venclexta plus Gazyva also had a higher progression-free survival rate at three years (87.7%), although this was not observed in those treated with Venclexta plus Rituxan (80.8%).

Severe and life-threatening infections occurred more often in patients in the chemoimmunotherapy (18.5%) and Venclexta-Gazyva-Imbruvica groups (21.2%) compared with those in the Venclexta-Rituxan (10.5%) and Venclexta-Gazyva groups (13.2%).

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