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ASH 2022: 4-Year Follow-up on Combination Therapy of Ibrutinib and Venetoclax in CLL

By: Jenna Carter, PhD
Posted: Thursday, January 5, 2023

A study presented at the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 95) reported the long-term outcomes with ibrutinib and venetoclax combination treatment in patients with chronic lymphocytic leukemia (CLL). Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues assessed progression-free survival in this study and found that 72% of patients achieved bone marrow–undetectable measurable residual disease (MRD) as the best response.

A total of 120 patients were included in this study (80 from an earlier publication and 40 from this expansion cohort). Patients received ibrutinib at 420 mg daily for three cycles followed by venetoclax (weekly dose escalation to 400 mg daily); combined therapy was administered for 24 cycles (28 days/cycle). An additional 12 cycles of combined therapy were administered to patients who remained MRD-positive (in the bone marrow) after the initial 24 cycles. Response assessments included bone marrow and combination therapy studies with undetectable MRD defined as < 0.01%; low MRD-positive 0.01% to < 1%; high MRD-positive ≥ 1%. Progression-free survival was assessed as the time from the start of the study drug to CLL progression, Richter transformation, or death from any cause.

After 24 cycles of the combination treatment, 64% of patients achieved bone marrow–undetectable MRD remission; 20% achieved bone marrow–MRD positivity. Overall, 72% of patients achieved bone marrow–undetectable MRD. The 4-year progression-free survival was 94.5%, and the 4-year overall survival was 96.6%. There was a total of 24 patients who achieved bone marrow–MRD positivity at the end of cycle 24, and 18 of them were cleared for and resumed an additional 12 cycles of treatment. During the third year of combined therapy, 11 of 18 patients (61%) had achieved undetectable-MRD remission.

Disclosure: For full disclosures of the study authors visit, ash.confex.com.


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