@article{7ef7da5263584753b14860bf07c2f4e4,
title = "Phase 2, multicenter GIBB study of obinutuzumab plus bendamustine in previously untreated patients with chronic lymphocytic leukemia",
abstract = "The single-arm, multicenter, phase 2 GIBB study (NCT02320487) investigated bendamustine plus obinutuzumab (BG) in previously untreated CLL. Patients (N = 102) received six cycles of intravenous obinutuzumab (cycle [C] 1: 100 mg day 1/900 mg day 2, and 1000 mg days 8/15; C2–6 1000 mg day 1) plus bendamustine (C1 90 mg/m2 days 2/3; C2–6 days 1/2). Complete response (CR), the primary endpoint, was 50%, overall response 89%. Estimated 2-year progression-free survival (PFS) and overall survival (OS) were 86% and 97%, respectively. Following initial minimal residual disease (MRD) negativity, median MRD negativity duration was 28.9 months. Undetectable MRD (<10−4) was observed in up to 83% of evaluable patients in peripheral blood (any time) and 59% in bone marrow at response evaluation. Most common grade 3/4 adverse events (AEs) were neutropenia (25%; 5% febrile) and infusion-related reactions (9%). BG proved clinically active in CLL with high response, MRD negativity, and survival rates, consistent with other first-line studies of anti-CD20 antibody/bendamustine combinations.",
keywords = "Bendamustine, chronic lymphocytic leukemia, minimal residual disease, obinutuzumab, survival",
author = "{on behalf of the GIBB study investigators} and Sharman, {Jeff P.} and Burke, {John M.} and Yimer, {Habte A.} and Boxer, {Michael A.} and Sunil Babu and Jia Li and Yong Mun and Danilov, {Alexey V.}",
note = "Funding Information: AVD reports consultancy and other travel reimbursement and research funding with Verastem Oncology; consultancy with Celgene, Curis, Janssen, Seattle Genetics, Teva Oncology, and TG Therapeutics; research funding with Aptose Biosciences, Bristol-Myers Squibb, and Takeda Oncology; and consultancy and research funding from AstraZeneca, Bayer Oncology, Genentech, and Gilead Sciences. Funding Information: We would like to thank the patients, their families and caregivers, and the study investigators, coordinators, and nurses who participated in the GIBB clinical trial. Thank you to the data monitoring committee that served as an independent expert advisory group to evaluate safety and efficacy throughout the study. We would also like to thank Ken Wilhelm, MD for his work on this study. This study was sponsored by Genentech, South San Francisco, CA. The authors directed development of the manuscript and were fully responsible for all content and editorial decisions for this manuscript. The GIBB study was sponsored by Genentech, South San Francisco, CA. Funding Information: JPS reports consultancy, honoraria, and research funding from AbbVie, Acerta, AstraZeneca, Celgene, Genentech, Gilead, Pharmacyclics LLC (an AbbVie Company), and TG Therapeutics; consultancy and research funding from Janssen and Seattle Genetics; and employment with Willamette Valley Cancer Institute and Research Center. Funding Information: JMB reports consultancy from AbbVie, AstraZeneca, Bayer, Celgene, Gilead, Juno, Kite, Roche/Genentech, Tempus Labs, and Verastem; consultancy and speakers{\textquoteright} bureau from Seattle Genetics; research funding from Janssen; and employment with Rocky Mountain Cancer Center. Publisher Copyright: {\textcopyright} 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.",
year = "2021",
doi = "10.1080/10428194.2020.1850719",
language = "English (US)",
volume = "62",
pages = "791--800",
journal = "Leukemia and Lymphoma",
issn = "1042-8194",
publisher = "Informa Healthcare",
number = "4",
}