Combination Ibrutinib Plus Venetoclax Improves Outcomes Compared With Chemoimmunotherapy in CLL

Among patients with previously untreated chronic lymphocytic leukemia (CLL), combination ibrutinib plus venetoclax appears to improve progression-free survival (PFS) rates compared with chemoimmunotherapy, according to research published in The Lancet Oncology. The authors noted, furthermore, that these findings support ibrutinib plus venetoclax as a first-line option in this patient population.

The randomized phase 3 GLOW study (ClinicalTrials.gov Identifier: NCT03462719) was designed to compare the safety and efficacy of combination ibrutinib plus venetoclax with chlorambucil plus obinutuzumab among patients with previously untreated CLL. For the present analysis, researchers conducted a 4-year follow-up from GLOW.

Overall, 211 patients were enrolled and randomly assigned to receive ibrutinib plus venetoclax (106 patients) or chlorambucil plus obinutuzumab (105 patients). In the cohort, 58% of patients were male.

The median follow-up was 46 months. Analysis showed that PFS was improved in the ibrutinib group (hazard ratio, 0.214; P <.0001); the 42-month PFS rates were 74.6% in the ibrutinib arm vs 24.8% with chlorambucil plus obinutuzumab.

Overall survival also appeared to be improved in the ibrutinib plus venetoclax group (hazard ratio, 0.487; P =.021), with an estimated 42-month overall survival rate of 87.5% vs 77.6% in the chlorambucil plus obinutuzumab group.

There was 1 patient in the chlorambucil plus obinutuzumab group who had a serious myelodysplastic syndrome event and 2 treatment-related deaths were reported in the ibrutinib plus venetoclax group. 

“In conclusion, these data should inform clinical practice as the outcomes observed at this 4-year timepoint support the use of ibrutinib–venetoclax combination as an all-oral, chemotherapy-free, fixed-duration treatment option for patients with previously untreated chronic lymphocytic leukaemia,” the authors wrote in their report.

Disclosures: This research was supported by Janssen Research & Development. Please see the original reference for a full list of disclosures.

Reference

Niemann CU, Munir T, Moreno C, et al. Fixed-duration ibrutinib-venetoclax versus chlorambucil-obinutuzumab in previously untreated chronic lymphocytic leukaemia (GLOW): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. Published online November 6, 2023. doi:10.1016/S1470-2045(23)00452-7

This article originally appeared on Hematology Advisor