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Bintrafusp alfa (M7824), a bifunctional fusion protein targeting TGF-β and PD-L1: results from a phase I expansion cohort in patients with recurrent glioblastoma

Khasraw, Mustafa, Weller, M, Lorente, D, Kolibaba, K, Lee, CK, Gedye, C, I. de La Fuente, M, Vicente, D, Reardon, DA, Gan, HK, Scott, AM, Dussault, I, Helwig, C, Ojalvo, LS, Gourmelon, C and Groves, M 2021, Bintrafusp alfa (M7824), a bifunctional fusion protein targeting TGF-β and PD-L1: results from a phase I expansion cohort in patients with recurrent glioblastoma, Neuro-Oncology Advances, vol. 3, no. 1, January-December, pp. 1-11, doi: 10.1093/noajnl/vdab058.

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Title Bintrafusp alfa (M7824), a bifunctional fusion protein targeting TGF-β and PD-L1: results from a phase I expansion cohort in patients with recurrent glioblastoma
Author(s) Khasraw, MustafaORCID iD for Khasraw, Mustafa orcid.org/0000-0003-3249-9849
Weller, M
Lorente, D
Kolibaba, K
Lee, CK
Gedye, C
I. de La Fuente, M
Vicente, D
Reardon, DA
Gan, HK
Scott, AM
Dussault, I
Helwig, C
Ojalvo, LS
Gourmelon, C
Groves, M
Journal name Neuro-Oncology Advances
Volume number 3
Issue number 1
Season January-December
Article ID vdab058
Start page 1
End page 11
Total pages 11
Publisher Oxford University Press
Place of publication Oxford, Eng.
Publication date 2021-01
ISSN 2632-2498
2632-2498
Keyword(s) bintrafusp alfa
glioblastoma
M7824
PD-L1
TGF-β
Summary Abstract Background For patients with recurrent glioblastoma (rGBM), there are few options following treatment failure with radiotherapy plus temozolomide. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-βRII receptor (a TGF-β “trap”) fused to a human IgG1 antibody blocking PD-L1. Methods In this phase I, open-label expansion cohort (NCT02517398), patients with rGBM that progressed after radiotherapy plus temozolomide received bintrafusp alfa 1200 mg Q2W until disease progression, unacceptable toxicity, or trial withdrawal. Response was assessed per RANO criteria. The primary endpoint was disease control rate (DCR); secondary endpoints included safety. Results As of August 24, 2018, 35 patients received bintrafusp alfa for a median of 1.8 (range, 0.5–20.7) months. Eight patients (22.9%) experienced disease control as assessed by an independent review committee: 2 had a partial response, 4 had stable disease, and 2 had non-complete response/non-progressive disease. Median progression-free survival (PFS) was 1.4 (95% confidence interval [CI], 1.2–1.6) months; 6- and 12-month PFS rates were 15.1% and 11.3%, respectively. Median overall survival (OS) was 5.3 (95% CI, 2.6–9.4) months; 6- and 12-month OS rates were 44.5% and 30.8%, respectively. The DCR (95% CI) was 66.7% (22.3–95.7%) for patients with IDH-mutant GBM (n = 6) and 13.8% (3.9–31.7%) for patients with IDH–wild-type GBM (n = 29). Disease control was seen regardless of PD-L1 expression. Twenty-five patients (71.4%) experienced treatment-related adverse events (grade ≥3; 17.1% [n = 6]). Conclusions The percentage of patients achieving disease control and the manageable safety profile may warrant further investigation of bintrafusp alfa in GBM.
Language eng
DOI 10.1093/noajnl/vdab058
HERDC Research category C1 Refereed article in a scholarly journal
Free to Read? Yes
Persistent URL http://hdl.handle.net/10536/DRO/DU:30152182

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.