Reference Detail

Ref Type

Journal Article

PMID

(32052473)

Authors

Timmerman J, Herbaux C, Ribrag V, Zelenetz AD, Houot R, Neelapu SS, Logan T, Lossos IS, Urba W, Salles G, Ramchandren R, Jacobson C, Godwin J, Carpio C, Lathers D, Liu Y, Neely J, Suryawanshi S, Koguchi Y, Levy R

Title

Urelumab alone or in combination with rituximab in patients with relapsed or refractory B-cell lymphoma.

Journal	Vol	Issue	Date	Pages	Journal Short Title
American journal of hematology	95	5	2020 05	510-520	Am J Hematol

URL

Abstract Text

Urelumab, a fully human, non-ligand binding, CD137 agonist IgG4 monoclonal antibody, enhances T-cell and natural killer-cell antitumor activity in preclinical models, and may enhance cytotoxic activity of rituximab. Here we report results in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and other B-cell lymphomas, in phase 1 studies evaluating urelumab alone (NCT01471210) or combined with rituximab (NCT01775631). Sixty patients received urelumab (0.3 mg/kg IV Q3W, 8 mg IV Q3W, or 8 mg IV Q6W); 46 received urelumab (0.1 mg/kg, 0.3 mg/kg, or 8 mg IV Q3W) plus rituximab 375 mg/m2 IV QW. The maximum tolerated dose (MTD) of urelumab was determined to be 0.1 mg/kg or 8 mg Q3W after a single event of potential drug-induced liver injury occurred with urelumab 0.3 mg/kg. Treatment-related AEs were reported in 52% (urelumab: grade 3/4, 15%) and 72% (urelumab + rituximab: grade 3/4, 28%); three led to discontinuation (grade 3 increased AST, grade 4 acute hepatitis [urelumab]; one death from sepsis syndrome [urelumab plus rituximab]). Objective response rates/disease control rates were 6%/19% (DLBCL, n = 31), 12%/35% (FL, n = 17), and 17%/42% (other B-cell lymphomas, n = 12) with urelumab and 10%/24% (DLBCL, n = 29) and 35%/71% (FL, n = 17) with urelumab plus rituximab. Durable remissions in heavily pretreated patients were achieved; however, many were observed at doses exceeding the MTD. These data show that urelumab alone or in combination with rituximab demonstrated manageable safety in B-cell lymphoma, but the combination did not enhance clinical activity relative to rituximab alone or other current standard of care.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials
Urelumab	Urelumab	0	4

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Urelumab		BMS-663513\|BMS663513\|BMS 663513	TNFRSF9 Antibody 30	Urelumab (BMS-663513) is an activating monoclonal antibody that targets CD137, resulting in activation of CD137-expressing immune cells, thereby enhancing T-cell mediated response to tumor cells (PMID: 31143521, PMID: 32052473).

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References