Glofitamab in combination with immunochemotherapy in patients with relapsed/refractory B‐cell non‐Hodgkin lymphoma: Phase 1b dose‐escalation study
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: Glofitamab was investigated with obinutuzumab/rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (G/R-CHOP) in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) who had ≥1 prior obinutuzumab/rituximab-containing therapy (NCT03467373). The primary end-point was to determine the optimal biological dose of glofitamab with R-CHOP. Using a modified continual reassessment method, glofitamab dose escalation was administered from cycle (C) 2 day (D)8 (70 μg, 1800 μg, 10 mg, 30 mg), with G/R- CHOP for 6-8 21-day cycles. The 70 and 1800 μg cohorts received fixed-dose glofitamab; the 10 and 30 mg cohorts received step-up dosing (C2D8, 2.5 mg; C2D15, 10 mg; C3D8+, 30 mg). Patients completing induction could receive glofitamab every 8 weeks for ≤2 years. Thirty-one patients with follicular lymphoma (including transformed), mantle cell lymphoma or marginal zone lymphoma received treatment. The most common adverse events (AEs) were anaemia and fatigue (each 58.1%). Grade 3/4 AEs occurred in 25 (80.6%) patients (serious AEs: 23 [74.2%]; grade 5 AEs: 4 [12.9%; mostly infections]). Sixteen (51.6%) patients experienced cytokine release syndrome (grade 1/2, n = 12 [38.7%]; grade 3/4, n = 4 [12.9%]). Complete metabolic response rate was 83.9%. Median progression-free survival was not reached after 44.2 months follow-up. Glofitamab plus G/R-CHOP showed promising benefit in relapsed/refractory B-NHL, supporting future investigation of glofitamab (2.5/10/30 mg) with R-CHOP in untreated diffuse large B-cell lymphoma.
Source: British Journal of Haematology
DOI: 10.1111/bjh.70741
Institutions: UCL Biomedical Research Centre, Levine Cancer Institute, Wake Forest University, University of Copenhagen, Rigshospitalet, The Royal Melbourne Hospital, The University of Melbourne, Peter MacCallum Cancer Centre, Ospedale "Santa Maria delle Croci" di Ravenna, Humanitas University, IRCCS Humanitas Research Hospital, Princess Margaret Cancer Centre, University of Alabama at Birmingham, University Medical Center Freiburg, Roche Pharma AG (Germany), Roche (United Kingdom), Roche (China), Genentech, Roche (Switzerland), Universitätsklinikum Würzburg
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,190
OpenAlex ID: W7203647249