Citations 1
Ibrutinib plus Obinutuzumab as Frontline Therapy for Chronic Lymphocytic Leukemia Is Associated with a Lower Rate of Infusion-Related Reactions and with Sustained Remissions after Ibrutinib Discontinuation: A Single-Arm, Open-Label, Phase 1b/2 Clinical Tri
Castro, Januario E. , Lengerke-Diaz, Paula A. , Luján, Juliana Vélez, Choi, Michael Y. , Moreno-Cortes, Eider , Forero-Forero, José Vicente , García-Robledo, Juan Esteban , Jacobs, C , McCarthy, Colin, Heinen, Alaina, Amaya-Chanaga, Carlos I., Moreno-Cortes, Eider F , Forero, Jose V , Jacobs, Chaja , Kipps, Thomas J , Castro, Januario E , Garcia-Robledo, Juan Esteban , Diaz, Paula A Lengerke , Kipps, Thomas J.
Advances in Hematology | January 22, 2022 | Volume: 2022 | Issue: No issue available | Pages: 1-8
Ibrutinib-based therapies are costly and require continuous administration. We hypothesized combining BTK inhibition with anti-CD20 monoclonal antibodies would yield deep remissions allowing discontinuation. We enrolled 32 therapy-naïve CLL patients to receive ibrutinib plus obinutuzumab, followed by single-agent ibrutinib. Patients could discontinue ibrutinib after 36 months with sustained complete response (CR). We evaluated treatment safety, efficacy, and outcomes after ibrutinib discontinuation. The overall response rate was 100%, 28% achieved a CR, and 12.5% achieved bone marrow undetectable minimal residual disease. At a three-year median follow-up, 91% remain in remission with 100% overall survival. Five patients in sustained CR stopped ibrutinib and have not progressed. Eight non-CR patients discontinued for other reasons, with only two progressing. The treatment was safe, with a lower IRR rate. All patients responded to treatment with longer time-to-progression after discontinuation of ibrutinib. Our data support the evaluation of ibrutinib discontinuation strategies in more extensive clinical trials (https://Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT02315768).