Fixed-duration ibrutinib and venetoclax produces similar outcomes in patients with chronic lymphocytic leukemia (CLL), regardless of high-risk features, according to study results published in Clinical Cancer Research.
Patients had similar progression-free survival (PFS) and overall survival (OS) outcomes whether they had high-risk features or not, the data showed.
This post hoc analysis from the phase 2 CAPTIVATE trial (ClinicalTrials.gov identifier: NCT02910583) included 202 patients who were treated with 3 cycles of ibrutinib followed by ibrutinib plus venetoclax for an additional 12 cycles. Patients received no further treatment, regardless of minimal residual disease (MRD) status.
Of the 195 patients with known risk status, 129 had at least 1 high-risk feature. This included 29 patients with del(17p) or a TP53 mutation and 119 patients with unmutated IGHV.
The overall response rate was 98% in patients with high-risk features and 96% in those without high-risk features. Rates of complete response (CR) or CR with incomplete count recovery were 61% and 53%, respectively.
The rate of undetectable MRD in the peripheral blood was 88% in patients with high-risk features and 70% in patients without high-risk features. In bone marrow, the rates of undetectable MRD were 72% and 61%, respectively.
The 36-month PFS rate was 88% in patients with high-risk features and 92% in patients without them. The 36-month OS rate was 98% and 100%, respectively.
The rates of grade 3-4 treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuation or dose reduction due to TEAEs were similar for patients with and without high-risk features.
“These results support first-line treatment with ibrutinib plus venetoclax as an all-oral, once-daily, chemotherapy-free, fixed-duration regimen that provides clinically meaningful PFS and treatment-free remissions in patients with CLL/SLL [small lymphocytic leukemia], including those with high-risk genomic features,” the researchers concluded.
Disclosures: This research was supported by Pharmacyclics, LLC, in collaboration with Janssen Research and Development, LLC. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Allan JN, Flinn IW, Siddiqi T, et al. Outcomes in patients with high-risk features after fixed-duration ibrutinib plus venetoclax: Phase II CAPTIVATE study in first-line chronic lymphocytic leukemia. Clin Cancer Res. Published online June 7, 2023. doi:10.1158/1078-0432.CCR-22-2779
This article originally appeared on Cancer Therapy Advisor