Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell–Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial

Martin Hutchings; Franck Morschhauser; Gloria Iacoboni; Carmelo Carlo‐Stella; Fritz Offner; Anna Sureda; Gilles Salles; Joaquín Martínez‐López; Michael Crump; Denise Thomas; Peter N. Morcos; Cristiano Ferlini; Ann-Marie E Bröske; Anton Belousov; Marina Bacac; Natalie Dimier; David Carlile; Linda Lundberg; David Pérez-Callejo; Pablo Umaña; Tom Moore; Maja Weisser; Michael Dickinson

doi:10.1200/jco.20.03175

Key Points

Assess the safety, pharmacokinetics, maximum tolerated dose, and preliminary efficacy of glofitamab in relapsed or refractory B-cell non-Hodgkin lymphoma.
Conducted a phase I dose-escalation trial using a Bayesian continuous reassessment method with overdose control to define safe dosing increments.
Treated 171 patients with relapsed or refractory B-cell non-Hodgkin lymphoma (N=171; 90.6% refractory to prior therapy; median 3 prior therapies; 74.3% aggressive histology) with at least one dose of glofitamab in multipatient cohorts.
Overall response rate across all dose cohorts was 53.8% (complete response, 36.8%), increasing to 65.7% (complete response, 57.1%) among patients receiving the recommended phase II dose.
Complete responses were durable, with 84.1% (53 of 63 patients) maintaining remission up to a maximum follow-up of 27.4 months.
Cytokine release syndrome occurred in 50.3% of patients (grade 3–4: 3.5%), grade 3 neurotoxicity occurred in 1.2%, and treatment-related adverse events prompted discontinuation in 2.9%.

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Implication

Phase I clinical trial reveals durable complete remissions from glofitamab in relapsed or refractory B-cell lymphoma, demonstrating potent antitumor efficacy with manageable toxicity.

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Hutchings et al. (2021) studied this question.

synapsesocial.com/papers/69fd8511d670694b88270ae0 https://doi.org/10.1200/jco.20.03175

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Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell–Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial

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Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell–Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial

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