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.

Details

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
Author
Spira, Alexander 1   VIAFID ORCID Logo  ; Wertheim, Michael S 2 ; Kim, Edward J 3 ; Tan, Benjamin 4 ; Lenz, Heinz-Josef 5 ; Nikolinakos, Petros 6 ; Rich, Patricia L 7 ; Jehl, Genevieve 8 ; Machl, Andreas 9 ; Ito, Rena 10 ; Gulley, James L 11 ; Kopetz, Scott 12   VIAFID ORCID Logo 

1  US Oncology Research , Fairfax, VA , USA 
2  Hematology Oncology Associates of the Treasure Coast , FL , USA 
3  Department of Internal Medicine, UC Davis Comprehensive Cancer Center , Sacramento, CA , USA 
4  Department of Medicine, Washington University School of Medicine, Siteman Cancer Center , St. Louis, MO , USA 
5  Department of Medicine, Keck School of Medicine, University of Southern California Norris Comprehensive Cancer Center , Los Angeles, CA , USA 
6  University Cancer & Blood Center , Athens, GA , USA 
7  Cancer Treatment Centers of America, Southeastern Regional Medical Center , Newnan, GA , USA 
8  Merck Healthcare KGaA , Darmstadt , Germany 
9  EMD Serono Research & Development Institute , Billerica, MA , USA an affiliate of Merck KGaA 
10  Merck Biopharma Co., Ltd. , Tokyo , Japan an affiliate of Merck KGaA 
11  Center for Cancer Research, National Cancer Institute, National Institutes of Health , Bethesda, MD , USA 
12  Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center , Houston, TX , USA 
Pages
e124-e127
Publication year
2023
Publication date
Feb 2023
Publisher
Oxford University Press
ISSN
10837159
e-ISSN
1549490X
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1093/oncolo/oyac254
ProQuest document ID
3191884089
Copyright
© The Author(s) 2022. Published by Oxford University Press. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.