Ten-year follow-up data from the phase 2 NCT01500733 trial showed that continuous treatment with Ibrutinib provides long-term disease control for patients with high-risk chronic lymphocytic leukemia (CLL), including those with TP53 abnormalities.
Among 84 patients, median progression-free survival reached 7.2 years, while median overall survival was not yet reached. The 10-year progression-free survival rate was 37.5%, and overall survival reached 59.6%.
Researchers also reported unexpected deep remissions. About 15.5% of patients achieved undetectable minimal residual disease after roughly five years of therapy, with some maintaining remission even after discontinuing treatment. Meanwhile, many patients with persistent residual disease still remained progression-free for more than five years, suggesting durable benefit can occur without complete MRD clearance.
The treatment was generally well tolerated. Main reasons for discontinuation included cardiac events such as atrial fibrillation, secondary cancers, and infections.