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

GI Medical Oncology

Research output: Contribution to journal › Article › peer-review

6 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 (US)
Pages (from-to)	e124-e127
Journal	The oncologist
Volume	28
Issue number	2
DOIs	https://doi.org/10.1093/oncolo/oyac254
State	Published - Feb 8 2023

Keywords

bintrafusp alfa
colorectal cancer
phase I

ASJC Scopus subject areas

Oncology
Cancer Research

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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. The oncologist, 28(2), e124-e127. https://doi.org/10.1093/oncolo/oyac254

Spira, A, Wertheim, MS, Kim, EJ, Tan, B, Lenz, HJ, Nikolinakos, P, Rich, PL, Jehl, G, Machl, A, Ito, R, Gulley, JL & 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', The oncologist, vol. 28, no. 2, pp. e124-e127. https://doi.org/10.1093/oncolo/oyac254

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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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doi = "10.1093/oncolo/oyac254",

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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

Abstract

Keywords

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