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Last Updated: 11/14/23

Information below provided by the Pharmaceutical Company.

Glofitamab-gxbm (COLUMVI™)

Agent Description

Glofitamab-gxbm is a full-length, humanized IgG1 bispecific monoclonal antibody with two ‘Fab’ regions that bind to CD20 and bind to CD3 in a 2:1 (CD20:CD3) format.

Mechanism of Action

Glofitamab-gxbm is a bispecific antibody that binds to CD20 expressed on the surface of B cells, and to CD3 receptor expressed on the surface of T cells. Glofitamab-gxbm causes T-cell activation and proliferation, secretion of cytokines, and the lysis of CD20-expressing B cells even under low effector-to-target cell ratios. Glofitamab-gxbm showed anti-tumor activity in vivo in mouse models of DLBCL.

Classification

Bispecific monoclonal antibody

Molecular Targets

CD20 expressed on the surface of B cells and CD3 receptor expressed on the surface of T cells.

Monograph

Glofitamab-gxbm is the first T-cell-engaging bispecific monoclonal antibody to demonstrate clinically meaningful outcomes for patients with R/R DLBCL. Glofitamab-gxbm is also being evaluated with preliminary efficacy data and favorable safety in the post-BTKi R/R MCL setting.

Package insert: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761309s000lbl.pdf

Studies of Interest

The incorporation of rich translational endpoints in any proposed study is encouraged. Depth and durability of response as measured by MRD/ctDNA clearance as well as biomarkers of response and toxicity.

Areas of interest include, but are not limited to:

  • DLBCL settings in patient populations at high risk for progression; in combination with chemotherapy or targeted agents (other than RGemOx and CHOP); or in consolidation post autologous stem cell transplantation
  • Patient populations with high unmet medical needs such as pediatrics or patients who are refractory to autologous SCT or CAR-T
  • Combination regimens in rare B-cell malignancies where there is strong biological rationale
  • Ways to decrease the risk of CRS in patients who receive glofitamab-gxbm
  • Rational combinations with treatment modalities such as immunomodulatory agents that enhance effector T-cell activity

Information collaborator would like included in investigator proposals

Sponsor-investigator must indicate appropriate facilities/personnel, experience treating patients in desired research population and that they have an adequate sample size they can enroll into study, and a proven track record for conducting and publishing research. Formulary LOI proposal needs to describe if they have ongoing studies at their institution that would compete with the research population of interest during the expected patient accrual window.