bintrafusp alfa

Phase 2Small molecule

EMD Serono Research & Development Institute, Inc.

Bintrafusp alfa is used to treat certain types of cancer, specifically unresectable or metastatic melanoma (a serious skin cancer). It works by helping the body's immune system recognize and attack cancer cells.[1] bintrafusp alfa is currently being investigated across 4 indications[3], with its most advanced program in Phase 2.[1]

bintrafusp alfa is one of 80 small molecule programs targeting Locally Advanced Intrahepatic Cholangiocarcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Locally Advanced Intrahepatic CholangiocarcinomaActive, not recruiting

Esophageal Squamous Cell CarcinomaActive, not recruiting

Advanced Soft-Tissue SarcomaActive, not recruiting

Oropharyngeal CancerActive, not recruiting

Locally Advanced Intrahepatic CholangiocarcinomaPhase 1

Active, not recruiting

Esophageal Squamous Cell CarcinomaPreclinical

Active, not recruiting

Advanced Soft-Tissue SarcomaPhase 2

Active, not recruiting

Oropharyngeal CancerPreclinical

Active, not recruiting

Competition

Competitive Landscape

108 competitors in Esophageal Squamous Cell Carcinoma

#DrugCompanyPhaseTrials

Taxol

Teva

Phase 3

31 2

Beyfortus

BeiGene

Phase 3

22 3

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

33 4

Camptosar

Pfizer

Phase 3

11 5

Keytruda

Merck & Co.

Phase 3

8 6

Abraxane

Bristol-Myers Squibb

Phase 3

4 7

Tuoyi

CCoherus Oncology, Inc.

Phase 3

13 8

Opdivo

Bristol-Myers Squibb

Phase 3

2 9

Tyvyt

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

9 10

Theraplaza

BBiotech Pharmaceutical Co., Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

PreclinicalActive, not recruiting

Oropharyngeal Cancer

NCT04708470

Q1 2027

Phase 1Active, not recruiting

Locally Advanced Intrahepatic Cholangiocarcinoma

NCT04708067

Q3 2027

Phase 2Active, not recruiting

Advanced Soft-Tissue Sarcoma

NCT04874311

Q3 2030

N/ARecruiting

Esophageal Squamous Cell Carcinoma

NCT04481256

Clinical

Trials by Indication[1]

Breast Cancer5 trials

Radiation Therapy and M7824 in Treating Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT03524170·24 enrolled

M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT03579472·38 enrolled

M7824 in Treating Patients With Stage II-III HER2 Positive Breast Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT03620201·20 enrolled

Show 2 more trials

Immunotherapy (NHS-IL12 & Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer, the REINA Trial

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT04756505

Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer

Terminated· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT04489940·11 enrolled

Non-Small Cell Lung Cancer4 trials

M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 1/2·NCT03840915·70 enrolled

Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer

Terminated·MMayo Clinic·Phase 2·NCT04396535·10 enrolled

Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04971187·3 enrolled

Show 1 more trial

Bintrafusp Alfa Before Surgery for the Treatment of Untreated Resectable Non-small Cell Lung Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04560686·2 enrolled

Urothelial Carcinoma2 trials

Preoperative Bintrafusp Alfa in Operable Urothelial Carcinoma of the Bladder

Unknown status·QQueen Mary University of London·Phase 2·NCT04878250·49 enrolled

A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT04501094·2 enrolled

Prostate Cancer1 trial

N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT05445882

Biliary Tract Cancer1 trial

Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer

Terminated·AAIO-Studien-gGmbH·Phase 2·NCT04727541·3 enrolled

14 more indications

Stereotactic Body Radiation Therapy1 trial

Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT04220775·3 enrolled

Selected Advanced Solid Tumors1 trial

Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)

Completed· GSK logo

GSK·Phase 1·NCT02723955·829 enrolled

Esophageal Squamous Cell Carcinoma1 trial

TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY

Recruiting·—·N/A·NCT04481256·49 enrolled

Cervical Cancer1 trial

Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT04246489·146 enrolled

Germ Cell Tumor1 trial

Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies

Withdrawn·NNational Cancer Institute (NCI)·Phase 1/2·NCT04648826

Head and Neck Squamous Cell Carcinoma1 trial

Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell Carcinoma

Terminated·UUNICANCER·Phase 2·NCT04428047·7 enrolled

NPC1 trial

Bintrafusp Alfa in Previously Treated Patients With R/M Non-keratinizing NPC

Completed·TThe University of Hong Kong·Phase 2·NCT04396886·38 enrolled

Malignant Pleural Mesothelioma1 trial

Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma

Completed·FFundación GECP·Phase 2·NCT05005429·47 enrolled

Brain Metastases1 trial

Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT04789668·8 enrolled

Advanced Urothelial Cancer1 trial

A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer

Terminated· GSK logo

GSK·Phase 1·NCT04349280·25 enrolled

Locally Advanced Intrahepatic Cholangiocarcinoma1 trial

"Window of Opportunity" Phase I Trial of Focal Radiotherapy and Bintrafusp Alfa In Patients With Advanced Intrahepatic Cholangiocarcinoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04708067·2 enrolled

Oropharyngeal Cancer1 trial

A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04708470·55 enrolled

Advanced Soft-tissue Sarcoma1 trial

Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST Study

Active, not recruiting·IInstitut Bergonié·Phase 2·NCT04874311·80 enrolled

Unspecified2 trials

First in Human Study of M6223

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 1·NCT04457778·58 enrolled

Bintrafusp Alfa Program Rollover Study

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 3·NCT05061823·22 enrolled

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for bintrafusp alfa. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — bintrafusp alfa compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for bintrafusp alfa. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — EMD Serono Research & Development Institute, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Programmed Cell Death 1 Ligand 1 Binding Agent; Transforming Growth Factor Beta Binding Agent[2]
Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: EMD Serono Research & Development Institute, Inc.

bintrafusp alfa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q3 2030

Trials by Indication[1]

Breast Cancer5 trials

Non-Small Cell Lung Cancer4 trials

Urothelial Carcinoma2 trials

Prostate Cancer1 trial

Biliary Tract Cancer1 trial

Stereotactic Body Radiation Therapy1 trial

Selected Advanced Solid Tumors1 trial

Esophageal Squamous Cell Carcinoma1 trial

Cervical Cancer1 trial

Germ Cell Tumor1 trial

Head and Neck Squamous Cell Carcinoma1 trial

NPC1 trial

Malignant Pleural Mesothelioma1 trial

Brain Metastases1 trial

Advanced Urothelial Cancer1 trial

Locally Advanced Intrahepatic Cholangiocarcinoma1 trial

Oropharyngeal Cancer1 trial

Advanced Soft-tissue Sarcoma1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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