Drug: glofitamab-gxbm plus gemcitabine and oxaliplatin
Glofitamab-gxbm is a bispecific CD20-directed CD3 T-cell engager; the U.S. Food and Drug Administration (FDA) granted glofitamab monotherapy accelerated approval for selected relapsed or refractory (R/R) large B-cell lymphomas in 2023.
Developer: F. Hoffmann-La Roche
Indication: R/R diffuse large B-cell lymphoma (DLBCL)
Expected PDUFA Date: July 20, 2025
Summary of Key Studies
The open-label phase III STARGLO study enrolled 274 patients with R/R DLBCL who were ineligible for transplant after one or more prior therapies. Patients were randomly assigned 2:1 to glofitamab plus gemcitabine oxaliplatin (Glofit-GemOx) or rituximab GemOx (R-GemOx). The primary endpoint was overall survival (OS).
With a median follow-up of 20.73 months, treatment with Glofit-GemOx was associated with a 38% reduction in the risk for death compared with R-GemOx (hazard ratio = 0.62, 95% CI 0.43-0.88). Median OS was almost doubled with Glofit-GemOx at 25.5 months compared with 12.9 months with R-GemOx. Fifty percent of patients assigned Glofit-GemOx achieved complete response (CR) compared with 22.0% of patients assigned R-GemOx.
Cytokine release syndrome occurred in 44% of patients but was mostly low grade.
All information was current as of press time.
A Chat with Joshua Brody, MD
ASH Clinical News asked Joshua Brody, MD, director of the Lymphoma Immunotherapy Program at the Icahn School of Medicine at Mount Sinai in New York, how the combination of glofitamab plus GemOx could affect clinical practice for physicians treating patients with DLBCL.
“The glofitamab plus GemOx combination will be completely practice changing when the FDA approves it,” Dr. Brody said. “In fact, it already has been, even prior to its approval.
“The STARGLO trial showed that this regimen yielded a 50% CR rate and a doubling of OS for these patients compared to a standard-of-care therapy,” Dr. Brody said. “A similar phase II study of epcoritamab plus GemOx [NCT04663347] showed comparable results with a 60% CR rate.”
According to Dr. Brody, many lymphoma specialists have been using both of these regimens for R/R DLBCL since the publication of these results, given the remarkable efficacy and similar safety to standard options. He also noted that these bispecific antibodies require one day of hospitalization.
“To make it easy for community oncologists getting started using these meds,” Dr. Brody said, “it’s a great idea to have an academic lymphoma doc’s cell phone number on speed dial.”
Information compiled by and interview conducted by Leah Lawrence, a freelance health writer and editor based in Delaware.
References
U.S. Food and Drug Administration. FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas. June 16, 2023. Accessed April 13, 2025. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell.
Abramson JS, Ku M, Hertzberg M, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. Lancet. 2024;404(10466):1940-1954.
Brody JD, Jorgensen J, Belada D, et al. Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial. Blood. 2025;145(15):1621-1631.
