bintrafusp alfa   Click here for help

GtoPdb Ligand ID: 11376

Synonyms: M7824 | MSB0011359C
Compound class: Antibody
Comment: Bintrafusp alfa (M7824) is an investigational bifunctional fusion protein that combines two TGFβ 'trap' domains (derived from the extracellular domain of TGFBR2) that are linked to each of the C-terminal domain of the heavy chains of an anti-PD-L1 IgG1 monoclonal (mAb) [1,3]. The antibody component is similar to the anti-PD-L1 mAb avelumab and similarly, bintrafusp alfa was developed as a cancer immunotherapeutic [5]. Based on evidence that both the TGFβ pathway and the PD-PD-L1/PD-1 immune checkpoint are associated with tumour immune evasion, simultaneous targeting these pathways was predicted to control tumour growth by restoring and enhancing anti-tumour immune responses [2,4].
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Summary of Clinical Use Click here for help
As of January 2021 ClinicalTrials.gov had >40 clinical trials involving bintrafusp alfa (M7824) in a range of solid tumours, including HPV associated malignancies. The most advanced was Phase 3 NCT03631706 that was comparing bintrafusp alfa with pembrolizumab (Keytruda®) in NSCLC.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT03427411 M7824 in Subjects With HPV Associated Malignancies Phase 2 Interventional National Institutes of Health Clinical Center (CC) 5
NCT02517398 MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors Phase 1 Interventional EMD Serono 5
NCT03631706 M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC) Phase 3 Interventional EMD Serono A press release in January 2021 stated that early analysis indicated that bintrafusp alfa failed to show superiority over pembrolizumab in this study, but at this time the full results had not been published.