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Safety and efficacy of obinutuzumab alone or with chemotherapy in previously untreated or relapsed/refractory chronic lymphocytic leukaemia patients: Final analysis of the Phase IIIb GREEN study Stilgenbauer, Stephan Bosch, Francesc Ilhan, Osman Kisro, Jens Mahé, Béatrice Mikuskova, Eva Institut Català de la Salut [Stilgenbauer S] Department of Internal Medicine III, Ulm University, Ulm and Innere Medizin I, Universitätsklinikum des Saarlandes, Homburg, Germany. [Bosch F] Servei d’Hematologia, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Ilhan O] Internal Medical Sciences Departments, Ankara University School of Medicine, Ankara, Turkey. [Kisro J] Onkologische Schwerpunktpraxis Lübeck, Lübeck, Germany. [Mahé B] Clinical Hematology, CHU Nantes Hôtel-Dieu, Nantes, France. [Mikuskova E] Department of Hemato-oncology II, National Cancer Institute, Bratislava, Slovakia Blokhin Vall d'Hebron Barcelona Hospital Campus Leucèmia limfocítica crònica Quimioteràpia combinada Prognosi DISEASES::Neoplasms::Neoplasms by Histologic Type::Leukemia::Leukemia, Lymphoid::Leukemia, B-Cell::Leukemia, Lymphocytic, Chronic, B-Cell ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Clinical Protocols::Antineoplastic Protocols::Antineoplastic Combined Chemotherapy Protocols ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome ENFERMEDADES::neoplasias::neoplasias por tipo histológico::leucemia::leucemia linfoide::leucemia de células B::leucemia linfocítica crónica de células B TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::protocolos clínicos::protocolos antineoplásicos::protocolos de quimioterapia antineoplásica combinada TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento Obinutuzumab; Leucèmia limfocítica crònica; Malaltia residual mínima Obinutuzumab; Leucemia linfocítica crónica; Enfermedad residual mínima Obinutuzumab; Chronic lymphocytic leukaemia; Minimal residual disease The manageable toxicity profile of obinutuzumab (GA101; G) alone or with chemotherapy in first-line (1L; fit and non-fit) and relapsed/refractory (R/R) patients with chronic lymphocytic leukaemia (CLL) was established in the primary analysis of the Phase IIIb GREEN trial (Clinicaltrials.gov: NCT01905943). The final analysis (cut-off, 31 January 2019) is reported here. Patients received G (1000 mg) alone (G-mono; fit and non-fit patients) or with chemotherapy [fludarabine and cyclophosphamide (FC; fit patients); chlorambucil (non-fit patients); bendamustine (any patient)]. Study endpoints were safety (primary) and efficacy (secondary). Subgroup analyses were performed on prognostic biomarkers in 1L CLL. Overall, 630 patients received 1L and 341 received R/R CLL treatment. At the final analysis, no new safety signals were observed [Grade ≥ 3 adverse events (AEs): 1L 82·7%, R/R 84·5%; serious AEs: 1L 58·1%, R/R 62·5%]. Neutropenia (1L 50·5%, R/R 53·4%) and thrombocytopenia (1L 14·6%, R/R 19·1%) were the most common Grade 3–5 AEs. G-mono-, G-bendamustine and G-FC-treated patients with unmutated immunoglobulin heavy chain trended towards shorter progression-free survival. Achievement of minimal residual disease negativity was greatest in 1L patients treated with G-FC. In this final analysis of the GREEN trial, the safety profile of G was consistent with current risk management strategies. Biomarker analyses supported efficacy in the specific subgroups. F. Hoffmann-La Roche Ltd. 2021-06-23T11:14:36Z 2021-06-23T11:14:36Z 2021-04 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Stilgenbauer S, Bosch F, Ilhan O, Kisro J, Mahé B, Mikuskova E, et al. Safety and efficacy of obinutuzumab alone or with chemotherapy in previously untreated or relapsed/refractory chronic lymphocytic leukaemia patients: Final analysis of the Phase IIIb GREEN study. Br J Haematol. 2021 Apr;193(2):325-338. 1365-2141 https://hdl.handle.net/11351/6091 10.1111/bjh.17326 33605445 000619541700001 http://hdl.handle.net/11351/6091 eng British Journal of Haematology;193(2) https://onlinelibrary.wiley.com/doi/10.1111/bjh.17326 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf Wiley Scientia