A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Summary

This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.

Timeline

Start

2021-02-23

Primary completion

2028-03-31

Completion

2028-03-31

Outcome

Met primary endpoint

paper overall survival was significantly improved with Glofit-GemOx versus R-GemOx PMID 39550172 ↗

release “The Phase III STARGLO study met its primary endpoint of overall survival.” gene.com ↗

release “Updated data from the pivotal Phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit” gene.com ↗

release “These updated data continue to demonstrate the statistically significant and clinically meaningful survival benefit” gene.com ↗

Publications

• Abramson JS, Townsend W, Fox CP, Ku M, Hertzberg M, Huang HQ, Zhang H, Yoon DH, Kim WS, Abdulhaq H, Herbaux C, Zaucha JM, Zhang QY, Chang H, Liu Y, Cheah CY, Ghesquieres H, Mulvihill E, Kesavan M, Kallemeijn M, Ta R, Choeurng V, Belousov A, Relf J, Bottos A, Lundberg L, Gregory GP. Glofitamab plus gemcitabine and oxaliplatin for relapsed/refractory DLBCL: 3-year follow-up of STARGLO. Blood Adv. 2026 Aug 11;10(15):5367-5377. doi: 10.1182/bloodadvances.2026019764.
• Sam J, Leclercq-Cohen G, Gebhardt S, Surowka M, Herter S, Lechner K, Relf J, Briner S, Varol A, Appelt B, Domocos I, Nicolini V, Bez M, Bommer E, Jenni S, Schoenle A, Le Clech M, Colombetti S, Klein C, Umana P, Lundberg P, Korfi K, Bottos A, Bacac M. Preclinical advances in glofitamab combinations: a new frontier for non-Hodgkin lymphoma. Blood. 2025 Oct 9;146(15):1824-1836. doi: 10.1182/blood.2025028863.
• Abramson JS, Ku M, Hertzberg M, Huang HQ, Fox CP, Zhang H, Yoon DH, Kim WS, Abdulhaq H, Townsend W, Herbaux C, Zaucha JM, Zhang QY, Chang H, Liu Y, Cheah CY, Ghesquieres H, Simko S, Orellana-Noia V, Ta R, Relf J, Dixon M, Kallemeijn M, Mulvihill E, Huang H, Lundberg L, Gregory GP. 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 Nov 16;404(10466):1940-1954. doi: 10.1016/S0140-6736(24)01774-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glofitamab	Monoclonal antibody	30 mg	Intravenous
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Background	Obinutuzumab	Monoclonal antibody	—	Intravenous
Background	Oxaliplatin	Small molecule	100 mg/m2	Intravenous
Background	Tocilizumab	Monoclonal antibody	—	Intravenous

Indications