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    DRUG:

    bintrafusp alfa (M7824)

    i
    Other names: M7824, MSB0011359C, MSB 0011359C, M-7824, GSK4045154, MSB-0011359C, GSK-4045154, GSK 4045154, M 7824
    Company:
    EMD Serono
    Drug class:
    PD-L1 inhibitor, TGFβ inhibitor
    Related drugs:
    10d
    M7824 Related Adverse Effects in Adults With Cancer (clinicaltrials.gov)
    P=N/A, N=232, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2025 --> Nov 2027 | Trial primary completion date: Nov 2025 --> Nov 2027
    Trial completion date • Trial primary completion date • Adverse events
    |
    bintrafusp alfa (M7824)
    3ms
    NHS-IL12 Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma (clinicaltrials.gov)
    P1/2, N=80, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Sep 2025 --> Dec 2028
    Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PDS01ADC
    7ms
    MS200647_0054: Bintrafusp Alfa Program Rollover Study (clinicaltrials.gov)
    P3, N=32, Completed, EMD Serono Research & Development Institute, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    bintrafusp alfa (M7824)
    8ms
    Tri-Ad5 vaccine plus bintrafusp alfa for newly diagnosed, advanced-stage head and neck cancer not associated with human papillomavirus infection. (PubMed, Oncologist)
    In this small study, Tri-Ad5 vaccine plus bintrafusp alfa resulted in CPD in 2/6 patients. Participants also had favorable 2-year RFS compared to historical values. Ongoing tissue and peripheral immunome analyses may provide mechanistic insight. (ClincalTrials.gov Identifier: NCT04247282; IRB Approved.).
    Journal
    |
    MUC1 (Mucin 1) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    bintrafusp alfa (M7824) • ETBX-011 • ETBX-051 • ETBX-061 • Tri-Ad5
    8ms
    A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers (clinicaltrials.gov)
    P1/2, N=55, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=107 --> 55
    Enrollment closed • Enrollment change
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 negative
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    Jingzhuda (entinostat) • bintrafusp alfa (M7824) • PDS01ADC
    9ms
    PRGN-2009 and bintrafusp alfa for patients with advanced or metastatic human papillomavirus-associated cancer. (PubMed, Cancer Immunol Immunother)
    PRGN-2009 was well tolerated, and immune responses were observed to PRGN-2009. Encouraging anti-tumor activity and OS were noted in the combination with BA arm, consisting mainly of checkpoint-resistant patients. Trial Registration ClinicalTrials.gov Identifier: NCT04432597.
    Journal
    |
    CXCL8 (Chemokine (C-X-C motif) ligand 8) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    bintrafusp alfa (M7824) • PRGN-2009
    10ms
    Novel Combination Immunotherapy and Clinical Activity in Patients With HPV-Associated Cancers: A Nonrandomized Clinical Trial. (PubMed, JAMA Oncol)
    In this trial, the combination of PDS0101, PDS01ADC, and bintrafusp alfa showed an acceptable safety profile and promising antitumor activity and improved OS in patients with HPV-16-positive cancers, in both ICB-naive and ICB-resistant patients, warranting further evaluation of the combination of PDS0101 and PDS01ADC with simultaneous PD-L1/TGF-β inhibition in these populations.
    Clinical • Journal
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
    10ms
    TIGIT inhibitor M6223 as monotherapy or in combination with bintrafusp alfa in patients with advanced solid tumors: a first-in-human, phase 1, dose-escalation trial. (PubMed, J Immunother Cancer)
    M6223±BA had a manageable safety profile, with RDEs defined for both monotherapy and combination therapy. Further evaluation of M6223 is ongoing in combination with the PD-L1 inhibitor avelumab in patients with advanced urothelial carcinoma (JAVELIN Bladder Medley; NCT05327530).
    P1 data • Journal
    |
    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Bavencio (avelumab) • bintrafusp alfa (M7824) • dargistotug (M6223)
    12ms
    Efficacy and Safety of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting Transforming Growth Factor-β and Programmed Death-Ligand 1, Plus Chemotherapy in Patients With Stage IV NSCLC. (PubMed, JTO Clin Res Rep)
    On the basis of an interim analysis, the data were considered mature, and no further analysis has been planned. Bintrafusp alfa with chemotherapy was found to have a manageable safety profile and encouraging clinical activity in patients with stage IV NSCLC.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    bintrafusp alfa (M7824)
    12ms
    20-C-0012: Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies (clinicaltrials.gov)
    P1, N=100, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CD4 (CD4 Molecule)
    |
    PD-L1 expression
    |
    bintrafusp alfa (M7824) • PDS01ADC
    1year
    NCI-2018-00919: M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability (clinicaltrials.gov)
    P1/2, N=4, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | N=74 --> 4
    Trial completion • Enrollment change • Combination therapy • Circulating tumor DNA • Metastases
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    bintrafusp alfa (M7824)
    1year
    Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (clinicaltrials.gov)
    P1/2, N=53, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion
    |
    TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
    |
    TMB-H • MSI-H/dMMR
    |
    bintrafusp alfa (M7824) • epacadostat (INCB024360) • Anktiva (nogapendekin alfa inbakicept-pmln)