Glofitamab-gxbm

(Columvi®)

Columvi®

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Drug updated on 4/16/2024

Dosage FormInjection (intravenous; 2.5 mg/2.5 mL [1 mg/mL] in a single-dose vial, 10 mg/10 mL [1 mg/mL] in a single-dose vial)
Drug ClassCD20-directed CD3 T-cell engagers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

Summary
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  • Glofitamab-gxbm (Columvi) is used for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy.
  • Two randomized controlled trials were analyzed to gather information about the efficacy and safety of this treatment in DLBCL and other forms of aggressive B-NHL.
  • The first study involved 155 patients with relapsed or refractory DLBCL, reporting a complete response rate of 39% and a progression-free survival rate at 12 months of 37%. Responses were consistent among patients previously treated with chimeric antigen receptor T-cell therapy.
  • The second study focused on 171 patients with predominantly refractory, aggressive B-NHL. An overall response rate of about 53.8% was observed, with a complete response rate across all doses of approximately 36.8%. With the recommended phase II dose regimen, these rates significantly increased to up to 65.7% ORR and 57.1% CRR, respectively.
  • Regarding the safety profile, cytokine release syndrome (CRS) was reported in both studies, affecting 63% and 50.3% of participants, respectively. Severe cases of CRS constituted 4% in the first study and 3.5% in the second. Other adverse events included neurological incidents at 3% in the first study, and transient immune effector cell-associated neurotoxicity syndrome-like symptoms affected only 1.2% in the second study.
  • Both studies underscore the potential benefit of Columvi for heavily pretreated patient populations, including those resistant to prior therapies such as CAR T-cell therapy, due to its ability to induce durable complete responses, especially when administered under recommended phase II dosage levels.

Product Monograph / Prescribing Information

Document TitleYearSource
Columvi (glofitamab-gxbm) Prescribing Information.2023Genentech Inc., South San Francisco, CA

Randomized Controlled Trials


Sex Distribution:

F:35%
M:65%
154Subjects

Year:

2022

Source:The New England Journal of Medicine