@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: 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. 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. 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",
}