Trials 55
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2021-05-18 | EMD Serono Research & Development Institute, Inc. | Results Data from EMD Serono’s Oncology Portfolio Highlight Significant Advances in Cancer Care at ASCO21 emdserono.com ↗
A pooled analysis of data from the Phase I INTR@PID Solid Tumor 001 study and a National Cancer Institute (NCI)-led Phase II study demonstrated that bintrafusp alfa monotherapy has a manageable safety profile and clinical activity in patients with platinum-pretreated, immune checkpoint inhibitor-naïve recurrent/metastatic cervical cancer. |
| 2021-03-16 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, Reports Topline Data for Bintrafusp Alfa as Second-Line Monotherapy Treatment in Biliary Tract Cancer prnewswire.com ↗
Though single-agent activity was observed, the study did not meet the pre-defined threshold that would have enabled regulatory filing for BTC in the second line setting. |
| 2021-03-16 | EMD Serono Research & Development Institute, Inc. | Results Merck KGaA, Darmstadt, Germany, Reports Topline Data for Bintrafusp Alfa as Second-Line Monotherapy Treatment in Biliary Tract Cancer emdserono.com ↗
Though single-agent activity was observed, the study did not meet the pre-defined threshold that would have enabled regulatory filing for BTC in the second line setting. |
| 2021-01-20 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany Announces Update on the INTR@PID Clinical Program Including Lung 037 Study prnewswire.com ↗
Based on this recommendation, Merck KGaA, Darmstadt, Germany has made the decision to discontinue the clinical trial, as the study is unlikely to meet the co-primary endpoint, specifically progression-free survival. |
| 2021-01-20 | EMD Serono Research & Development Institute, Inc. | Results Merck KGaA, Darmstadt, Germany Announces Update on the INTR@PID Clinical Program Including Lung 037 Study emdserono.com ↗
Based on this recommendation, Merck KGaA, Darmstadt, Germany has made the decision to discontinue the clinical trial, as the study is unlikely to meet the co-primary endpoint, specifically progression-free survival. |
| 2020-09-14 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Advances Oncology Portfolio and Pipeline with New and Long-term Data in Multiple Cancers at ESMO 2020 emdserono.com ↗
Long-term follow-up data for novel bifunctional fusion protein targeting TGF-β/PD-L1, bintrafusp alfa‡, in NSCLC and BTC demonstrate continued durability of response |
| 2018-12-10 | Merck KGaA, Darmstadt, Germany | Regulatory Merck KGaA, Darmstadt, Germany Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer prnewswire.com ↗
FDA grants M7824, an investigational bifunctional immunotherapy, orphan drug designation in biliary tract cancer |
| 2018-10-22 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, Presents Updated Results for Bifunctional Immunotherapy M7824 at ESMO 2018 Congress prnewswire.com ↗
today announced new and updated results from expansion cohorts of two ongoing M7824 Phase I clinical trials (NCT02517398 and NCT02699515) at the ESMO (European Society for Medical Oncology) 2018 Congress in Munich , October. |
| 2018-06-04 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany Presents Updated Clinical Results for Bifunctional Immunotherapy M7824 at ASCO 2018 prnewswire.com ↗ |
| 2018-05-17 | Merck KGaA, Darmstadt, Germany | Results Merck Data at ASCO 2018 to Showcase Progress and Further Optionality of Oncology Pipeline prnewswire.com ↗
Early clinical activity in advanced NSCLC and HPV-associated cancers for investigational bifunctional immunotherapy, M7824 |
| 2018-05-16 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany Data at ASCO 2018 to Showcase Progress and Further Optionality of Oncology Pipeline prnewswire.com ↗
Early clinical activity in advanced NSCLC and HPV-associated cancers for investigational bifunctional immunotherapy, M7824 |
All press releases naming this drug 13 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bintrafusp alfa | “Bintrafusp alfa (M7824) is a novel first-in-class bifunctional fusion protein composed of a monoclonal antibody against PD-L1 fused to the extracellular domain of human...” NCT04235777 ↗33“The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor...” NCT03631706 ↗ “Bintrafusp alfa (M7824) is a bifunctional fusion protein consisting of an anti-programmed death ligand 1 (PD-L1) antibody functioning as an immune checkpoint inhibitor and the...” NCT04327986 ↗ “Bintrafusp alfa (BA) is a bifunctional fusion protein composed of the extracellular domain of the transforming growth factor-β (TGF-β) receptor II fused to a human...” PMID 36066618 ↗ Sep 2022 “An Open Label, Single-arm, Multi-center Phase 1b/2 Combination Study of M7824 (Bintrafusp Alfa) and Paclitaxel in Recurrent/Metastatic Gastric Cancer as a Second-line Treatment” NCT04835896 ↗ “Bintrafusp alfa (M7824)” NCT04417660 ↗ |
| Known as | 8L9YQ2N6PA | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298024 ↗ |
| Known as | M7824 | “In this study, the optimal dose of inhaled AZA will be established in patients with unresectable pulmonary metastases who are receiving the dual immune checkpoint...” NCT04648826 ↗27“A Phase II Study of N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer” NCT05445882 ↗ “A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer” NCT04349280 ↗ “a bifunctional fusion protein targeting PD-L1 and TGF beta (M7824 (MSB0011359C)” NCT04491955 ↗ “Bintrafusp alfa (M7824)” NCT04417660 ↗ “Bintrafusp alfa (M7824)” NCT04501094 ↗ |
| Known as | MSB0011359C | “Bintrafusp alfa (M7824 or MSB0011359C) is a bifunctional protein composed of the extracellular domain of the Transforming Growth Factor Beta Receptor 2 (TGF-BetaRII) receptor...” NCT04574583 ↗5“1/ Arm 1-Gemcitabine + de-escalating dose of M7824 (MSB0011359C)” NCT03451773 ↗ |
| Action | Inhibit | “monoclonal antibody blocking PD-L1” PMID 33840050 ↗ Apr 2021 |
| Modality | Protein / enzyme biologic | “M7824 (MSB0011359C) is an innovative first-in-class bifunctional fusion protein” PMID 29298798 ↗ Jan 2018 |
| Route | Intravenous | “intravenous infusion of MSB0011359C once every 2 weeks” NCT02517398 ↗ |
| Target | CD274 | “Programmed cell death 1 ligand 1 binding agent” CHEMBL4298024 ↗ |