Obinutuzumab plus bendamustine in previously untreated patients with CLL: a subgroup analysis of the GREEN study

Leukemia
Stephan StilgenbauerFrancesc Bosch

Abstract

GREEN (NCT01905943) is a non-randomized, open-label phase IIIb study investigating obinutuzumab alone or plus chemotherapy in chronic lymphocytic leukemia (CLL). We report a preplanned subgroup analysis of 158 previously untreated CLL patients receiving obinutuzumab-bendamustine (G-B). Patients received six 28-day cycles (C) of G-B: obinutuzumab day (D)1/D2 of C1 (25 mg D1/975 mg D2), 1000 mg D8 and D15 of C1, and D1 of C2-6; and bendamustine 70/90 mg/m2 D1 and D2 of C1-6. The primary endpoint was safety/tolerability. Grade ≥3 adverse events (AEs) occurred in 82.3% of patients, including neutropenia (49.4%), thrombocytopenia (12.0%) and febrile neutropenia (10.8%). Serious AEs included neutropenia (12.7%), febrile neutropenia (9.5%) and pneumonia (7.6%). Rates of grade ≥3 infections and infusion-related reactions were 20.3% and 17.1%, respectively. Due to tumor lysis syndrome (TLS; 8.2%), including two associated fatalities (one in another study cohort), additional risk-minimization measures were implemented. Overall response rate was 81.0%. After 32.8 months' median observation time, 2-year progression-free survival was 81.8%. Minimal residual disease was undetectable in 59.5% (94/158) and 27.8% (44/158) of patients for blood ...Continue Reading

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Citations

Sep 18, 2018·Expert Opinion on Pharmacotherapy·Laura S Samples, Solomon A Graf
Jan 23, 2019·Leukemia & Lymphoma·Anca Prica, Michael Crump
Feb 25, 2020·Expert Opinion on Biological Therapy·Iwona HusTadeusz Robak
Sep 27, 2019·Frontiers in Oncology·Ilaria Del GiudiceRobin Foà
Mar 17, 2020·Current Oncology Reports·Kate MilneTimothy Chevassut
Aug 17, 2021·The Cancer Journal·Antonio CuneoGian Matteo Rigolin

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Methods Mentioned

BETA
biopsy
flow cytometry

Clinical Trials Mentioned

NCT01905943

Software Mentioned

GREEN

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