Hematology AdvisorIanalumab, Ibrutinib Combination Promising in Chronic Lymphocytic Leukemia

As reported at the at the AACR Annual Meeting 2023, the combination of Ianalumab and ibrutinib showed promising results in treating chronic lymphocytic leukemia (CLL) in a phase 1b, dose-escalation and expansion trial. Ianalumab, an anti-BAFF-R monoclonal antibody, works by inhibiting B-cell differentiation, proliferation, and survival, and depleting B-cells through antibody-dependent cellular cytotoxicity within the tumor microenvironment. The trial treated 15 patients with CLL who were already receiving ibrutinib with different doses of Ianalumab for 6 cycles, with patients continuing the combination up to cycle 8 if they showed evidence of disease, and then followed up every 3 months for 2 years.

The ORR at cycle 9 or before treatment discontinuation was 56.7%, with a complete response (CR) rate of 37.8%. Patients who were in their first line of treatment showed better outcomes than patients who had relapsed or refractory disease, with the ORR for previously-untreated patients being 81.8% with a CR of 54.5% and a CR + CRi of 63.6%. Additionally, 45.9% of patients achieved undetectable minimal residual disease (uMRD) in blood or bone marrow by cycle 9 of treatment, including 63.6% of patients in their first line of therapy and 38.5% of patients with relapsed/refractory disease. There were no dose-limiting toxicities, and the combination was well-tolerated with an acceptable safety profile.