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 ( 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 unless patients experienced progressive disease or unacceptable toxicity.

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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