Bintrafusp Alfa: A Bifunctional Fusion Protein Targeting PD-L1 and TGF-β, in Patients with Pretreated Colorectal Cancer: Results from a Phase I Trial

Alexander Spira; Michael S. Wertheim; Edward J. Kim; Benjamin Tan; Heinz Josef Lenz; Petros Nikolinakos; Patricia L. Rich; Genevieve Jehl; Andreas Machl; Rena Ito; James L. Gulley; Scott Kopetz

doi:10.1093/oncolo/oyac254

Bintrafusp Alfa: A Bifunctional Fusion Protein Targeting PD-L1 and TGF-β, in Patients with Pretreated Colorectal Cancer: Results from a Phase I Trial

Alexander Spira, Michael S. Wertheim, Edward J. Kim, Benjamin Tan, Heinz Josef Lenz, Petros Nikolinakos, Patricia L. Rich, Genevieve Jehl, Andreas Machl, Rena Ito, James L. Gulley, Scott Kopetz

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11 Scopus citations

Abstract

Colorectal cancer (CRC) is a heterogeneous and complex disease with limited treatment options. Targeting transforming growth factor β (TGF-β) and programmed death ligand 1 pathways may enhance antitumor efficacy. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of TGF-β receptor II (a TGF-β “trap”) fused to a human IgG1 monoclonal antibody blocking programmed cell death ligand 1. We report results from an expansion cohort of a phase I study (NCT02517398) in patients with heavily pretreated advanced CRC treated with bintrafusp alfa. As of May 15, 2020, 32 patients with advanced CRC had received bintrafusp alfa for a median duration of 7.1 weeks. The objective response rate was 3.1% and the disease control rate was 6.3% (1 partial response, 1 stable disease); 2 patients were not evaluable. The safety profile was consistent with previously reported data.

Original language	English
Pages (from-to)	e124-e127
Journal	Oncologist
Volume	28
Issue number	2
DOIs	https://doi.org/10.1093/oncolo/oyac254
State	Published - Feb 2023

Keywords

bintrafusp alfa
colorectal cancer
phase I

Access to Document

10.1093/oncolo/oyac254

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Spira, A., Wertheim, M. S., Kim, E. J., Tan, B., Lenz, H. J., Nikolinakos, P., Rich, P. L., Jehl, G., Machl, A., Ito, R., Gulley, J. L., & Kopetz, S. (2023). Bintrafusp Alfa: A Bifunctional Fusion Protein Targeting PD-L1 and TGF-β, in Patients with Pretreated Colorectal Cancer: Results from a Phase I Trial. Oncologist, 28(2), e124-e127. https://doi.org/10.1093/oncolo/oyac254

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title = "Bintrafusp Alfa: A Bifunctional Fusion Protein Targeting PD-L1 and TGF-β, in Patients with Pretreated Colorectal Cancer: Results from a Phase I Trial",

abstract = "Colorectal cancer (CRC) is a heterogeneous and complex disease with limited treatment options. Targeting transforming growth factor β (TGF-β) and programmed death ligand 1 pathways may enhance antitumor efficacy. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of TGF-β receptor II (a TGF-β “trap”) fused to a human IgG1 monoclonal antibody blocking programmed cell death ligand 1. We report results from an expansion cohort of a phase I study (NCT02517398) in patients with heavily pretreated advanced CRC treated with bintrafusp alfa. As of May 15, 2020, 32 patients with advanced CRC had received bintrafusp alfa for a median duration of 7.1 weeks. The objective response rate was 3.1% and the disease control rate was 6.3% (1 partial response, 1 stable disease); 2 patients were not evaluable. The safety profile was consistent with previously reported data.",

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author = "Alexander Spira and Wertheim, {Michael S.} and Kim, {Edward J.} and Benjamin Tan and Lenz, {Heinz Josef} and Petros Nikolinakos and Rich, {Patricia L.} and Genevieve Jehl and Andreas Machl and Rena Ito and Gulley, {James L.} and Scott Kopetz",

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year = "2023",

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doi = "10.1093/oncolo/oyac254",

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AU - Wertheim, Michael S.

AU - Kim, Edward J.

AU - Tan, Benjamin

AU - Lenz, Heinz Josef

AU - Nikolinakos, Petros

AU - Rich, Patricia L.

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AU - Gulley, James L.

AU - Kopetz, Scott

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AB - Colorectal cancer (CRC) is a heterogeneous and complex disease with limited treatment options. Targeting transforming growth factor β (TGF-β) and programmed death ligand 1 pathways may enhance antitumor efficacy. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of TGF-β receptor II (a TGF-β “trap”) fused to a human IgG1 monoclonal antibody blocking programmed cell death ligand 1. We report results from an expansion cohort of a phase I study (NCT02517398) in patients with heavily pretreated advanced CRC treated with bintrafusp alfa. As of May 15, 2020, 32 patients with advanced CRC had received bintrafusp alfa for a median duration of 7.1 weeks. The objective response rate was 3.1% and the disease control rate was 6.3% (1 partial response, 1 stable disease); 2 patients were not evaluable. The safety profile was consistent with previously reported data.

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Bintrafusp Alfa: A Bifunctional Fusion Protein Targeting PD-L1 and TGF-β, in Patients with Pretreated Colorectal Cancer: Results from a Phase I Trial

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