Drug updated on 4/16/2024
| Dosage Form | Injection (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 Class | CD20-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
- 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 Title | Year | Source |
|---|---|---|
| Columvi (glofitamab-gxbm) Prescribing Information. | 2023 | Genentech Inc., South San Francisco, CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Glofitamab for relapsed or refractory diffuse large B-Cell Lymphoma. | 154Subjects F: 35% M: 65% | 2022 | The New England Journal of Medicine |
| 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. | 171Subjects F: 41% M: 59% | 2021 | Journal of Clinical Oncology |
Sex Distribution:
F:35%
M:65%
154Subjects
Year:
2022
Source:The New England Journal of Medicine
Sex Distribution:
F:41%
M:59%
171Subjects
Year:
2021
Source:Journal of Clinical Oncology