^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    bintrafusp alfa (M7824)

    i
    Other names: M7824, MSB0011359C, MSB 0011359C, M-7824, GSK4045154, MSB-0011359C, GSK-4045154
    Company:
    EMD Serono
    Drug class:
    PD-L1 inhibitor, TGFβ inhibitor
    Related drugs:
    18d
    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=107, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025
    Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 negative
    |
    Jingzhuda (entinostat) • bintrafusp alfa (M7824) • PDS01ADC
    18d
    A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer (clinicaltrials.gov)
    P1, N=25, Terminated, GlaxoSmithKline | Active, not recruiting --> Terminated; Primary investigator withdrew the participant due to an SAE
    Trial termination • Metastases
    |
    bintrafusp alfa (M7824)
    19d
    Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (clinicaltrials.gov)
    P1/2, N=53, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=113 --> 53
    Enrollment closed • Enrollment change
    |
    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)
    20d
    Blockade of TGF-β and PD-L1 by bintrafusp alfa promotes survival in preclinical ovarian cancer models by promoting T effector and NK cell responses. (PubMed, Br J Cancer)
    Our preclinical studies of BA in advanced ovarian cancer models support further testing of BA as an improved immunotherapy option for patients with advanced ovarian cancer.
    Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    PD-L1 expression • IFNG expression
    |
    bintrafusp alfa (M7824)
    1m
    N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, National Cancer Institute (NCI) | N=28 --> 0 | Trial completion date: Aug 2026 --> Apr 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Nov 2024 --> Apr 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Combination therapy
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln)
    2ms
    Efficacy, safety, and biomarker analyses of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with advanced non-small cell lung cancer. (PubMed, J Immunother Cancer)
    Bintrafusp alfa was observed to have modest clinical activity and manageable safety, and was associated with notable immunologic changes involving modulation of the tumor immune microenvironment in patients with advanced NSCLC.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    bintrafusp alfa (M7824)
    2ms
    Hyperprogressive disease following bintrafusp alfa and DNA damaging chemotherapy in relapsed small cell lung cancer (AACR 2024)
    Cohort 1 enrolled patients with relapsed SCLC across Arms A (bintrafusp alfa 2400 mg q3 wks), B (bintrafusp alfa 2400 mg on D1 plus topotecan 1 mg/m2/day on D1-5 q3 wks), and C (bintrafusp alfa 1200 mg on D1 q2 wks plus temozolomide 200 mg/m2/day on D1-5 q4 wks). Concomitant TGF-beta and PD-L1 blockade is associated with a high frequency of HPD in SCLC patients. cfDNA could be critical for monitoring HPD. Tumor and blood immune signatures may inform the likelihood of HPD, with immune excluded tumors more likely to develop HPD.NCT Number: NCT03554473Bintrafusp alfa was provided by EMD Serono (CrossRef Funder ID: 10.13039/100004755)
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • IL10 (Interleukin 10) • CCL19 (C-C Motif Chemokine Ligand 19) • TGFB1 (Transforming Growth Factor Beta 1) • CCL8 (C-C Motif Chemokine Ligand 8) • GZMH (Granzyme H)
    |
    DELFI-Tumor Fraction assay
    |
    temozolomide • topotecan • bintrafusp alfa (M7824)
    2ms
    LUNG 037: 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) (clinicaltrials.gov)
    P3, N=304, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Mar 2024 --> Jun 2024
    Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • bintrafusp alfa (M7824)
    3ms
    Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    bintrafusp alfa (M7824)
    3ms
    Combination Immunotherapy in Biochemically Recurrent Prostate Cancer (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    bintrafusp alfa (M7824) • Panvac-VF (falimarev/inalimarev) • ProstVac (rilimogene galvacirepvec)
    3ms
    M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers (clinicaltrials.gov)
    P1/2, N=80, Recruiting, National Cancer Institute (NCI) | Phase classification: P2 --> P1/2 | Trial primary completion date: Jan 2024 --> Jan 2025
    Phase classification • Trial primary completion date • Tumor mutational burden
    |
    temozolomide • topotecan • bintrafusp alfa (M7824)
    3ms
    Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON). (clinicaltrials.gov)
    P2, N=32, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Aug 2025
    Enrollment closed • Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824)
    4ms
    Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma (clinicaltrials.gov)
    P2, N=38, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Jan 2024 --> Dec 2024
    Trial primary completion date
    |
    bintrafusp alfa (M7824)
    4ms
    21-C-0001: M9241 in Combination With Docetaxel in Adults With Metastatic Castration Sensitive and Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1/2, N=86, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    docetaxel • abiraterone acetate • prednisone • bintrafusp alfa (M7824) • PDS01ADC
    4ms
    Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=10, Terminated, Mayo Clinic | N=80 --> 10 | Trial completion date: Dec 2024 --> Dec 2023 | Active, not recruiting --> Terminated; EMD Serono recommendation based on three other studies that failed to show benefit for bintrafusp alfa
    Enrollment change • Trial completion date • Trial termination • Metastases
    |
    docetaxel • bintrafusp alfa (M7824)
    4ms
    Phase 1 trial of first-line bintrafusp alfa in patients with locally advanced or persistent/recurrent/metastatic cervical cancer. (PubMed, Clin Cancer Res)
    Bintrafusp alfa had manageable safety and demonstrated clinical activity, further supporting the investigation of TGF-β/PD-L1 inhibition in HPV-associated cancers, including cervical cancer.
    P1 data • Journal • Metastases
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    Avastin (bevacizumab) • cisplatin • carboplatin • paclitaxel • bintrafusp alfa (M7824)
    5ms
    Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases (clinicaltrials.gov)
    P1/2, N=8, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Dec 2023 | Trial primary completion date: May 2025 --> Dec 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    HR positive
    |
    bintrafusp alfa (M7824) • pimasertib (AS703026)
    5ms
    20-C-0012: Bintrafusp Alfa (M7824) and NHS-IL12 (M9241) Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies (clinicaltrials.gov)
    P1, N=66, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CD4 (CD4 Molecule)
    |
    PD-L1 expression
    |
    bintrafusp alfa (M7824) • PDS01ADC
    5ms
    Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (clinicaltrials.gov)
    P1/2, N=113, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    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)
    5ms
    First in Human Study of M6223 (clinicaltrials.gov)
    P1, N=58, Completed, EMD Serono Research & Development Institute, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    bintrafusp alfa (M7824) • dargistotug (M6223)
    5ms
    20-C-0104: HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers (clinicaltrials.gov)
    P1/2, N=39, Active, not recruiting, National Cancer Institute (NCI) | N=20 --> 39 | Trial completion date: Oct 2023 --> Nov 2025
    Enrollment change • Trial completion date
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PRGN-2009
    6ms
    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 2023 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Nov 2024
    Trial completion date • Trial primary completion date • Adverse events
    |
    bintrafusp alfa (M7824)
    6ms
    Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov)
    P2, N=32, Active, not recruiting, National Cancer Institute (NCI) | Completed --> Active, not recruiting | N=23 --> 32 | Trial completion date: Feb 2023 --> Jan 2026
    Enrollment closed • Enrollment change • Trial completion date • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5) • CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)
    6ms
    MS200647_0055: Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC (clinicaltrials.gov)
    P2/3, N=309, Terminated, EMD Serono Research & Development Institute, Inc. | Completed --> Terminated; Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this study as the study was unlikely to achieve the primary objective of overall survival.
    Trial termination
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    cisplatin • gemcitabine • bintrafusp alfa (M7824)
    6ms
    Effect of CD4+ T cell count on treatment-emergent adverse events among patients with and without HIV receiving immunotherapy for advanced cancer. (PubMed, J Immunother Cancer)
    There was no significant difference in baseline CD4 or the proportions of any TEAE and grade ≥3 TEAE by HIV status. CD4 count thresholds for cancer clinical trials should be carefully reviewed to avoid unnecessarily excluding patients with HIV and cancer.
    Retrospective data • Journal • Adverse events • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • Imfinzi (durvalumab) • bintrafusp alfa (M7824)
    6ms
    N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=28, Not yet recruiting, National Cancer Institute (NCI) | Trial primary completion date: Nov 2023 --> Nov 2024
    Trial primary completion date • Combination therapy
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln)
    6ms
    LUNG 037: 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) (clinicaltrials.gov)
    P3, N=304, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Nov 2023 --> Mar 2024
    Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • bintrafusp alfa (M7824)
    7ms
    Coordinated blockade of TGF-β and PD-L1 by bintrafusp alfa promotes survival in preclinical ovarian cancer models by promoting T effector memory responses (SITC 2023)
    Conclusions These results show that coordinated blockade of TGF-β and PD-L1 by bintrafusp alfa leads to acquired anti-tumor immunity in HGSC models. Since bintrafusp alfa has advanced to clinical trials in other cancers, this project has potential to inform new immunotherapy regimes for ovarian cancer patients.
    Preclinical • BRCA Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • GZMB (Granzyme B) • TGFB1 (Transforming Growth Factor Beta 1) • ITGAE (Integrin Subunit Alpha E)
    |
    bintrafusp alfa (M7824)
    8ms
    NHS-IL12 Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma (clinicaltrials.gov)
    P1/2, N=64, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2028
    Trial completion date • Combination therapy • Metastases
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PDS01ADC
    8ms
    20-C-0012: Bintrafusp Alfa (M7824) and NHS-IL12 (M9241) Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies (clinicaltrials.gov)
    P1, N=66, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Sep 2023 --> Dec 2023
    Trial primary completion date • Combination therapy • Metastases
    |
    CD4 (CD4 Molecule)
    |
    PD-L1 expression
    |
    bintrafusp alfa (M7824) • PDS01ADC
    8ms
    Efficacy, safety, and correlative biomarkers of bintrafusp alfa in recurrent or metastatic nasopharyngeal cancer patients: a phase II clinical trial. (PubMed, Lancet Reg Health West Pac)
    Bintrafusp alfa demonstrated modest activity in R/M NPC but high rates of HPD and treatment discontinuation secondary to TRAEs are concerning. The project was supported by Alice Ho Miu Ling Nethersole Charity Foundation Professorship Endowed Fund and Merck KGaA.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    PD-L1 expression
    |
    bintrafusp alfa (M7824)
    9ms
    Bintrafusp alfa versus pembrolizumab in patients with treatment-naive, PD-L1-high advanced non-small cell lung cancer: a randomized, open-label, phase 3 trial. (PubMed, J Thorac Oncol)
    First-line treatment with bintrafusp alfa did not demonstrate superior efficacy compared with pembrolizumab in patients with PD-L1-high, advanced NSCLC.
    P3 data • Journal • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Keytruda (pembrolizumab) • bintrafusp alfa (M7824)
    9ms
    Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) (clinicaltrials.gov)
    P1; Active, not recruiting --> Completed
    Combination therapy • Trial completion • Metastases
    |
    MSI (Microsatellite instability) • ICOS (Inducible T Cell Costimulator)
    |
    MSI-H/dMMR
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • 5-fluorouracil • pemetrexed • Jemperli (dostarlimab-gxly) • bintrafusp alfa (M7824) • cobolimab (TSR-022) • feladilimab (GSK3359609) • GSK3174998
    9ms
    A phase Ib single-arm trial of bintrafusp alfa (BA) for pretreated, locally advanced/unresectable or metastatic (advanced) urothelial cancer (aUC) (ESMO 2023)
    Limitations: relatively small sample size and no randomization. Future studies can assess the role of TGF-β pathway inhibition in UC.
    P1 data • Metastases
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    bintrafusp alfa (M7824)
    10ms
    LUNG 037: 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) (clinicaltrials.gov)
    P3, N=304, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Jul 2023 --> Nov 2023
    Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • bintrafusp alfa (M7824)
    10ms
    Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies (clinicaltrials.gov)
    P1/2, N=51, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jul 2026 | Trial primary completion date: Jun 2023 --> Jul 2022
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CD4 (CD4 Molecule)
    |
    PD-L1 negative
    |
    bintrafusp alfa (M7824) • PDS0101 • PDS01ADC
    10ms
    Combination Immunotherapy in Biochemically Recurrent Prostate Cancer (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    bintrafusp alfa (M7824) • Panvac-VF (falimarev/inalimarev) • ProstVac (rilimogene galvacirepvec)
    11ms
    Dual targeting of TGF-β and PD-L1 inhibits tumor growth in TGF-β/PD-L1-driven colorectal carcinoma. (PubMed, Life Sci)
    Furthermore, M7824 inhibited tumor growth via targeting TGF-β and PD-L1 pathways, resulting in modulation of inflammatory response and fibrosis via TNF-α/IL6/CD4-8 and COL1A1/1A2, respectively. In conclusion, our data illustrated that co-targeting PD-L1 and TGF-β pathways increased the effect of Fluorouracil (5-FU) and reduced the tumor growth in PD-L1/TGF-β expressing tumors, providing a new therapeutic option in the treatment of CRC.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CCND1 (Cyclin D1) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • TGFB1 (Transforming Growth Factor Beta 1) • COL1A1 (Collagen Type I Alpha 1 Chain) • MMP9 (Matrix metallopeptidase 9) • CORIN (Corin, Serine Peptidase)
    |
    PD-L1 expression
    |
    5-fluorouracil • bintrafusp alfa (M7824)
    11ms
    Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection (clinicaltrials.gov)
    P1/2, N=21, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    CDKN2A negative
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-051 • ETBX-061
    12ms
    A multistate modeling and simulation framework to learn dose-response of oncology drugs: Application to bintrafusp alfa in non-small cell lung cancer. (PubMed, CPT Pharmacometrics Syst Pharmacol)
    Despite dose failed to be statistically significant for any individual transition, the combined effect quantified through a model with dose-specific transition estimates was still informative. Simulations predicted a 69.2% probability of at least 1 month longer, and, 55.6% probability of at least 2-months longer median OS from the 1200 mg compared to the 500 mg dose, supporting the selection of 1200 mg for future studies.
    Journal
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    bintrafusp alfa (M7824)
    12ms
    Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) (clinicaltrials.gov)
    P1/2, N=12, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Oct 2021 --> Feb 2023
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)
    |
    HER-2 amplification • HER-2 negative • CDKN2A negative
    |
    bintrafusp alfa (M7824) • SX-682 • Panvac-VF (falimarev/inalimarev)
    1year
    Peripheral immunological response to treatment with a novel bifunctional anti-PD-L1/TGFβRII agent in recurrent/metastatic nasopharyngeal carcinoma. (ASCO 2023)
    The apoptotic response of peripheral blood TEMRA CD4 T cells (CD95DR/R vsNR) may be a useful surrogate biomarker for predicting prognosis to M7824 therapy in NPC. The finding of a lower frequency of CD95D0TEMRA in R patients suggesting that CD95 may potentially act as a biomarker for predicting treatment response as well as reveal a possible target for guiding therapeutic strategy for R/M NPC. >
    PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD8 (cluster of differentiation 8) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • TGFB1 (Transforming Growth Factor Beta 1) • FAS (Fas cell surface death receptor)
    |
    bintrafusp alfa (M7824)