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The Food and Drug Administration (FDA) has granted accelerated approval to Columvi® (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after 2 or more lines of systemic therapy.
Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed with a novel 2:1 structural format targeting CD20 expressed on the surface of B cells and to CD3 receptor expressed on the surface of T cells.
The approval was based on data from the open-label, multicenter, multicohort, single-arm phase 1/2 NP30179 study (ClinicalTrials.gov Identifier: NCT03075696) which evaluated the efficacy and safety of glofitamab in 132 patients with R/R DLBCL after 2 or more lines of systemic therapy. Patients received glofitamab via intravenous infusion, starting with a 2.5mg step-up dose on Cycle 1 Day 8, followed by a 10mg step-up dose on Cycle 1
Day 15, then 30mg on Cycle 2 Day 1 and on Day 1 of each subsequent cycle. The cycle length was 21 days. Glofitamab was administered for up to 12 cycles or until disease progression or unacceptable toxicity.
Results demonstrated an overall response rate of 56% (n=74/132; 95% CI, 47-65), with 43% (n=57; 95% CI, 35-52) achieving complete response and 13% (n=13; 95% CI, 8-20) achieving partial response. The median time to first response was 42 days (range, 31 to 178 days). After an estimated median follow-up for duration of response (DOR) of 11.6 months, the median DOR was 18.4 months (95% CI, 11.4-Not estimable).
As for safety, the most common adverse reactions (incidence at least 20%) were cytokine release syndrome (CRS), musculoskeletal pain, rash, and fatigue. The most common (incidence at least 20%) Grade 3 to 4 laboratory abnormalities are decreased lymphocyte count, decreased phosphate, decreased neutrophil count, increased uric acid, and decreased fibrinogen.
Columvi carries a Boxed Warning associated with a risk for CRS, including serious or fatal reactions. To reduce the risk for CRS, initiate treatment with Columvi step-up dosing and appropriate premedication.
Columvi is supplied as 2.5mg/2.5mg and 10mg/10mL single-dose vials.
This article originally appeared on MPR
References:
- FDA approves Genentech’s Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma. News release. Genentech. Accessed June 16, 2023. https://www.businesswire.com/news/home/20230613097002/en/FDA-Approves-Genentech%E2%80%99s-Columvi-the-First-and-Only-Bispecific-Antibody-With-a-Fixed-Duration-Treatment-for-People-With-Relapsed-or-Refractory-Diffuse-Large-B-cell-Lymphoma.
- Columvi. Package insert. Genentech; 2023. Accessed June 16, 2023. https://www.gene.com/download/pdf/columvi_prescribing.pdf.
