Glofitamab + GemOx Superior to Rituximab + GemOx for Lymphoma
26 Jun 2024
Clinical ResultClinical StudyPhase 3
WEDNESDAY, June 26, 2024 -- Glofitamab (Glofit) plus gemcitabine and oxaliplatin (GemOx) is superior to rituximab (R)-GemOx for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), according to a study presented at the annual hybrid congress of the European Hematology Association, held from June 13 to 16 in Madrid.
Jeremy Abramson, M.D., from the Massachusetts General Hospital Cancer CenterCancer Center in Boston, and colleagues examined the efficacy and safety of Glofit-GemOx versus R-GemOx in patients with R/R DLBCL after one or more prior lines of therapy. A total of 274 patients were randomly assigned in a 2:1 ratio to receive Glofit-GemOx or R-GemOx (183 and 91 individuals, respectively).
The researchers observed a significant overall survival benefit with Glofit-GemOx versus R-GemOx at primary analysis (cutoff date, March 29, 2023). Median overall survival was not reached for Glofit-GemOx versus nine months for R-GemOx at a median follow-up of 11.3 months. Independent review committee-assessed progression-free survival and complete remission rate demonstrated a significant benefit for Glofit-GemOx. Glofit-GemOx continued to demonstrate superior median overall survival, median progression-free survival, and complete remission rates at follow-up analysis conducted once all patients had completed therapy (cutoff date, Feb. 16, 2024; median follow-up, 20.7 months) versus R-GemOx. Adverse event rates were higher with Glofit-Gemox than R-GemOx, including grade 3 to 4 and grade 5 adverse events and serious adverse events; however, the rates were similar after adjustment for exposure differences.
"Glofitamab in combination with GemOx showed clinically significant improvement in overall survival, as well as key secondary end points, and the benefits were reinforced with an additional 11 months of follow-up," Abramson said in a statement.
The study was funded by Genentech, the manufacturer of glofitamab.
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