The combination of ibrutinib and rituximab demonstrates activity in first-line follicular lymphoma. British journal of haematology Fowler, N. H., Nastoupil, L., De Vos, S., Knapp, M., Flinn, I. W., Chen, R., Advani, R. H., Bhatia, S., Martin, P., Mena, R., Davis, R. E., Neelapu, S. S., Eckert, K., Ping, J., Co, M., Beaupre, D. M., Neuenburg, J. K., Palomba, M. L. 2020


This phase 2 study evaluated the activity and safety of ibrutinib, a Bruton's tyrosine kinase inhibitor, plus rituximab in adults with previously untreated follicular lymphoma. Patients received once-daily ibrutinib 560mg continuously plus once-weekly rituximab 375mg/m2 for 4weeks beginning Week 1 (Arm 1, n=60) or Week 9 (following an 8-week ibrutinib lead-in) to explore biomarkers (Arm 2, n=20). The primary endpoint was the best overall response rate (ORR). The median age was 58years; most had an Eastern Cooperative Oncology Group Performance Status of 0 (74%) and Stage III/IV disease (84%). At a median study follow-up of 34months in Arm 1 and 29months in Arm 2, ORRs were 85% [95% confidence interval (CI) 73-93] and 75% (95% CI 51-91), respectively, with complete responses in 40% and 50%. The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2). The most common adverse events were fatigue, diarrhoea and nausea. Higher grade (Grade 3/4) haematological, haemorrhagic and cardiac events occurred infrequently. Ibrutinib plus rituximab was active and tolerable in first-line follicular lymphoma.

View details for DOI 10.1111/bjh.16424

View details for PubMedID 32180219