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.
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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.
Reference
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
