Glofitamab is a "two-headed" (bispecific) antibody: one end attaches to the lymphoma cell (CD20) and the other to an immune T cell, bringing the two together so that the T cell kills the cancer cell. Unlike CAR-T, this drug is ready to use and does not need cells to be made in a laboratory. In patients for whom several earlier treatments had failed, about 4 in 10 went into complete remission, and treatment stops after about 8 months. The most common side effect is fever and low blood pressure (CRS) after the first doses, which is usually mild.
Relapsed or refractory DLBCL or LBCL arising from follicular lymphoma after 2 or more lines of therapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Cycle 1, Day 1 (pretreatment) | |||
| Obinutuzumab | 1,000 mg | IV | Day 1 |
| Cycle 1 | |||
| Glofitamab | 2.5 mg (Day 8), 10 mg (Day 15) | IV | Days 8 and 15 |
| Cycles 2–12 | |||
| Glofitamab | 30 mg | IV | Day 1 |
Premedication before each dose, including dexamethasone; hospitalisation during and for 24 hours after the 2.5 mg dose (and after subsequent doses if CRS occurred previously).
DLBCL or LBCL arising from follicular lymphoma, relapsed or refractory after at least 2 lines of systemic therapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Cycle 1 | |||
| Obinutuzumab (pretreatment) | 1000 mg | IV | Day 1 |
| Glofitamab (step-up dose 1) | 2.5 mg | IV | Day 8 |
| Glofitamab (step-up dose 2) | 10 mg | IV | Day 15 |
| Cycles 2–12 | |||
| Glofitamab | 30 mg | IV | Day 1 |
Per the FDA label for COLUMVI: hospitalisation during and for 24 hours after the 2.5 mg dose (and after the 10 mg dose if CRS of any grade occurred with the previous dose); premedication with dexamethasone 20 mg IV (cycle 1, Days 8 and 15; cycles 2 and 3), acetaminophen and an antihistamine; adequate hydration and tumour lysis syndrome prophylaxis in high-risk patients; antiviral prophylaxis against herpes and consideration of CMV and Pneumocystis prophylaxis. Dose reduction of glofitamab is not recommended. CRS occurred in 63% of patients in the trial.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Obinutuzumab 1000 mg IV once, 7 days before the first dose of glofitamab (to reduce cytokine release syndrome).
Glofitamab IV in 21-day cycles with step-up dosing: 2.5 mg on day 8 and 10 mg on day 15 of cycle 1, then 30 mg on day 1 of cycles 2 to 12 (12 cycles in total, fixed duration). Hospitalisation during and for 24 hours after the first step-up dose is recommended.
Source of the regimen details: FDA label for COLUMVI (Dosage and Administration section, 2026 version) and ClinicalTrials.gov NCT03075696 (obinutuzumab pretreatment 1000 mg on day -7)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who had received at least two prior lines of therapy; 52 patients had previously received CAR-T therapy.
Primary endpoint: complete response as assessed by an independent review committee.
Key secondary endpoints: duration of response, survival and safety.
Cytokine release syndrome (CRS) was the most common adverse event (63%); grade 3 or higher CRS 4%. Grade 3 or higher neurological events 3%. Grade 3 or higher adverse events overall 62%, and discontinuation of glofitamab because of adverse events 9%.
Based on this study, the FDA granted accelerated approval to glofitamab (Columvi) in June 2023 for relapsed or refractory DLBCL after two or more lines of systemic therapy, and the EMA granted conditional approval. In the phase 3 STARGLO trial, glofitamab combined with gemcitabine and oxaliplatin (GemOx) improved overall survival compared with R-GemOx in transplant-ineligible patients; this combination was approved by the European Commission in April 2025, but an FDA advisory committee voted against its applicability to the US population in May 2025.
The study is single-arm with no comparator group, and the primary endpoint is complete response. 12-month progression-free survival in the overall population was limited (37%), although complete responses were durable. Follow-up in this report was about one year.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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