@article{9a9879cad75c4661b5bd38a594765c89,
title = "The combination of ibrutinib and rituximab demonstrates activity in first-line follicular lymphoma",
abstract = "This phase 2 study evaluated the activity and safety of ibrutinib, a Bruton{\textquoteright}s tyrosine kinase inhibitor, plus rituximab in adults with previously untreated follicular lymphoma. Patients received once-daily ibrutinib 560 mg continuously plus once-weekly rituximab 375 mg/m2 for 4 weeks 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 58 years; 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 34 months in Arm 1 and 29 months 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.",
keywords = "follicular lymphoma, ibrutinib, rituximab",
author = "Fowler, {Nathan H.} and Loretta Nastoupil and {De Vos}, Sven and Mark Knapp and Flinn, {Ian W.} and Robert Chen and Advani, {Ranjana H.} and Sumeet Bhatia and Peter Martin and Raul Mena and Davis, {Richard Eric} and Neelapu, {Sattva S.} and Karl Eckert and Jerry Ping and Melannie Co and Beaupre, {Darrin M.} and Neuenburg, {Jutta K.} and Palomba, {M. Lia}",
note = "Funding Information: We thank all patients who participated in the PCYC-1125-CA phase 2 study and their families, as well as the study sub-investigators, research nurses and co-ordinators at each study site. We also thank Catherine Cheung for clinical study support and data collection. Medical writing and editorial assistance was provided by Kimberly Brooks, PhD, CMPP and supported by funding from Pharmacyclics, LLC, an AbbVie Company. This study was sponsored by Pharmacyclics, LLC, an AbbVie Company. Funding Information: We thank all patients who participated in the PCYC‐1125‐CA phase 2 study and their families, as well as the study sub‐investigators, research nurses and co‐ordinators at each study site. We also thank Catherine Cheung for clinical study support and data collection. Medical writing and editorial assistance was provided by Kimberly Brooks, PhD, CMPP and supported by funding from Pharmacyclics LLC, an AbbVie Company. This study was sponsored by Pharmacyclics LLC, an AbbVie Company. Publisher Copyright: {\textcopyright} 2020 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd",
year = "2020",
month = may,
day = "1",
doi = "10.1111/bjh.16424",
language = "English (US)",
volume = "189",
pages = "650--660",
journal = "British Journal of Haematology",
issn = "0007-1048",
publisher = "Wiley-Blackwell",
number = "4",
}