Drug updated on 12/11/2024
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 | Bispecific 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.
Latest News
Summary
- This summary is based on the review of one randomized controlled trial. [1]
- Glofitamab demonstrated a 39% complete response (CR) rate (95% confidence interval (CI), 32 to 48) among 155 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including a 35% CR rate in a subgroup of 52 patients who had previously received Chimeric Antigen Receptor (CAR) T-cell therapy.
- The median time to achieve a complete response was 42 days (95% CI, 42 to 44), and 78% of those who achieved CR maintained it at 12 months. The 12-month progression-free survival (PFS) rate was 37% (95% CI, 28 to 46).
- No direct comparative effectiveness data with other drugs were provided in the source.
- Cytokine release syndrome (CRS) was the most common adverse event, occurring in 63% of patients, with 4% experiencing CRS of grade 3 or higher. Neurologic events of grade 3 or higher occurred in 3% of patients.
- Adverse events of grade 3 or higher occurred in 62% of patients, and 9% of patients discontinued glofitamab due to adverse events.
- The study focused on patients with relapsed or refractory DLBCL who had received at least two lines of previous therapy. Among the 52 patients who had previously received CAR T-cell therapy, the complete response rate was 35%, slightly lower than the overall response rate of 39%. No specific safety data for this subgroup were provided.
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 | N Engl J Med |
Sex Distribution:
F:35%
M:65%
154Subjects
Year:
2022
Source:N Engl J Med