Bintrafusp Alfa, an Anti-PD-L1:TGFβ Trap Fusion Protein, in Patients with ctDNA-positive, Liver-limited Metastatic Colorectal Cancer
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Abstract
Identification of circulating tumor DNA (ctDNA) following curative intent therapies is a surrogate for microscopic residual disease for patients with metastatic colorectal cancer (mCRC). Preclinically, in micrometastatic microsatellite stable (MSS) colorectal cancer, increased TGFβ signaling results in exclusion of antitumor cytotoxic T cells from the tumor microenvironment. Bintrafusp alfa (BA) is a bifunctional fusion protein composed of the extracellular domain of the TGFβRII receptor (“TGFβ trap”) and anti-PD-L1 antibody. Patients with liver-limited, MSS mCRC and with detected ctDNA after complete resection of all known tumors and standard-of-care therapy were treated with 1,200 mg of BA intravenously every 14 days for six doses. The primary endpoint was ctDNA clearance. Radiographic characteristics at recurrence were compared using independent t tests to historical data from a similar cohort of patients with liver-limited mCRC who underwent observation. Only 4 of 15 planned patients received BA before the study was stopped early for loss of equipoise. There was no grade ≥3 adverse event. None of the patients cleared ctDNA. All patients developed radiographic recurrence by the first planned restaging. Although not detectable at prior to treatment, TGFβ3 was found in circulation in all patients at cycle 2 day 1. Compared with a historical cohort, patients administered BA developed more metastases (15 vs. 2, P = 0.005) and greater tumor volumes (9 cm vs. 2 cm, P = 0.05). Treatment with BA in patients with ctDNA-detected, liver-limited mCRC did not clear ctDNA and was associated with large-volume recurrence, highlighting the potential context-specific complexity of dual TGFβ and PD-L1 inhibition. Significance: Use of ctDNA to identify patients with micrometastatic disease for therapeutic intervention is feasible. Treatment with BA in patients with liver-limited mCRC and with detectable ctDNA after resection generated rapid progression. Approaches targeting TGFβ signaling must consider its pathway complexity in future immunotherapy combination strategies.
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Dual TGFβ and PD-L1 inhibition with bintrafust alfa was not effective in patients with liver metastasis.
“dual TGFβ and PD-L1 inhibition with bintrafust alfa was not effective in patients with liver metastasis (62).”
From Clinical Challenges of Consensus Molecular Subtype CMS4 Colon Cancer in the Era of Precision Medicine (2024) · cites this paper as [62]
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Reframing cancer therapy through tumor plasticity
Shah, A. M., Marsh, B., & de Sauvage, F. J. (2026) · Nature Cancer · doi:10.1038/s43018-026-01232-0
- Authors
- Morris, V. K., Overman, M. J., Lam, M., Parseghian, C. M., Johnson, B., Dasari, A., Raghav, K., Kee, B. K., Huey, R., Wolff, R. A., Shen, J. P., Li, J., Zorrilla, I., Tzeng, C.-W. D., Tran Cao, H. S., Chun, Y. S., Newhook, T. E., Vauthey, N., Duose, D., Luthra, R., Haymaker, C., & Kopetz, S.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- The University of Melbourne (AU)
- 4Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
- Corresponding author
- Morris, Van K.
- ORCID
- Venue
- Cancer Research Communications
- Published
- 2022-09-14
- Volume
- 2
- Issue
- 9
- Pages
- 979-986
- ISSN
- 2767-9764 (ISSN-L)
- PMC
- PMC9648419
- OpenAlex
- W4290975641
- Cited by
- 38
- References
- 44
- Citations by year
- 2026: 11 · 2025: 9 · 2024: 11 · 2023: 5 · 2022: 2
- FWCI
- 2.83
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Cancer Research Communications (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Digital Commons-TMC (Texas Medical Center) (submittedVersion)
- Funders
- HHS | NIH | National Cancer Institute (K12 CA088084, L30 CA171000, K22 CA234406, U24 CA224285, CA016672)
- Cancer Prevention and Research Institute of Texas (RP220416, RP200356, RR180035)
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › TGF-β signaling in diseases
- Keywords
- bintrafusp alfa, PD-L1 inhibitors, TGF-β trap, TGF-beta signaling, circulating tumor DNA, microsatellite stable colorectal cancer, ctDNA clearance, tumor recurrence, TGF-beta3, tumor microenvironment, immune checkpoint inhibitors, early trial termination
- MeSH terms
- Colonic Neoplasms, Humans, Immunologic Factors, Liver Neoplasms, Rectal Neoplasms, Colorectal Neoplasms, Tumor Microenvironment
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