Anne Sophie Michallet, MD, PhD, on MRD-Guided vs Standard Combination Therapy for Select Untreated Patients With CLL

Okay. With the emergence of targeted therapy, choosing the best first-line strategy in CLL remains challenging. So we have discussed the result of the ERADIC study, this is the phase two study begun with the fellow French organization. This study randomized 120 patients between two types of strategies. The first one is six cycles of standard FCR, and the second one is a combination of IV after leading phase of three months with ibrutinib alone. The total duration of this combination depended was based on the result at month nine, according to the result of the bone marrow minimal residual disease. If patient have bone marrow minimal residual disease undetectable, so the patient continue for six months and stop at month 15. For the others, the patient continue 18 months and stop at month 27. The primary endpoint of this study is the rate of undetectable minimal residual disease in the bone marrow at 127. We presented here the final result of this trial. According to the result of the minimal residual disease and the result of the progression-free survival. In term of bone marrow minimal residual disease, we did not show statistically significance between the two arms with 55% of bone marrow undetectable minimal residual disease for FC versus 68% for IV. But the study highlight a very important rate of peripheral blood undetectable minimal residual disease for the IV arm with 85% and depth response of minimal residual disease in term of progression-free survival. Also, the study highlight IV arm with superiority of the progression for survival for IV arm with 95% versus 82%. In term of safety, safety is very important. We have two different type of toxicity, myelosuppression for FCA, you know you are hematologist and for IV, cardiological toxicity and metabolic disorders. In term of deceased, three deceased for the FCA one myelodysplasia, one acute myeloid leukemia, and one septic shock. For the IV, we have three deceased, two third deaths and one COVID-19 patient-related diseases. For this trial, we could conclude that IV is superior than FCA in term of depths of response and also in term of progression-free survival. But we have to take strict account to the profile of the patient for IV young fit and without comorbidity, particularly cardiovascular.